Celebrex and Vioxx Update

Bextra Lawsuits Filed in New York

2005-04-19T14:20:00.000-04:00

Three Bextra Lawsuits Filed in New York
The Philadelphia lawfirm of Kline & Specter, has announced that they have filed three Bextra lawsuits against Pfizer Inc. on behalf of three individuals who allegedly were injured by the pain relief drug, Bextra. Two of the plaintiffs suffered heart attacks and one sustained a stroke after taking Bextra, attorneys for the plaintiffs stated.

Pfizer, the world's largest drug maker, suspended sales of Bextra in the United States and the European Union after the Food and Drug Administration concluded that its overall risk versus benefit profile is "unfavorable."

The Bextra lawsuits, filed in the Supreme Court of the State of New York on Friday, claim Pfizer failed to adequately and properly test Bextra, and failed to warn doctors, patients and others about its potential risks.

The plaintiffs in the Bextra lawsuits are Luis G. Flores, 33, of Texas, Jimmy Kitchen, 67, of Arkansas, and Theodis Maddox, Jr., 48, of Arkansas.

Many more Bextra lawsuits can be expected.

Law Change Would Help Vioxx and Bextra Sufferers

2005-04-18T14:48:00.000-04:00

Proposal Could Aid Vioxx and Bextra Victims
(Salem Ore.)A bill expanding the number of people who can sue due to health problems caused by Vioxx and Bextra got its first hearing in the Senate Thursday. Prior to 2004 state law required that victioms must file lawsuits within two years of suffering an injury.

For many Vioxx and Bextra users, the statute of limitations ran out before the drugs were found to cause heart disease. This two year limitation unfairly restricted some patients' right to sue.

The bill, would change the deadline for filing lawsuits to two years after the cause of an injury is discovered. For Vioxx users, that would be Sept. 30, 2004, the date it was removed from the market.

Bill Limits Vioxx and Bextra Victims Ability to Sue
Mike Yukert testified for his wife, (who sat in a wheelchair beside him, cannot speak and is paralyzed on her right side because of the stroke he believes was caused by Vioxx.)"Imagine how frustrated you'd feel if, simply because you live in Oregon, that we cannot have our day in court," he said.

The law effectively blocks Yukert's wife from seeking damages because her stroke happened in 2002. No action has yet been taken by the Senate committee.

FDA Calls for Bextra Recall

2005-04-09T16:25:00.000-04:00

Bextra to be Recalled - Warning Labels Added to Celebrex
The FDA has asked Pfizer Inc. to withdraw the painkiller drug, Bextra from the market. Pfizer and other manufacturers have also been asked to revise their labels to include boxed warnings of potential cardiovascular risks and gastrointestinal bleeding from certain arthritis drugs. What follows is the FDA's statement:

The FDA today announced a series of important changes pertaining to the marketing of the non-steroidal anti-inflammatory class of drugs, including COX-2 selective and prescription and non-prescription (over-the-counter (OTC)) non-selective NSAID medications.

"Today's actions protect and advance the health of the millions of Americans who rely on these drugs everyday," said Dr. Steven K. Galson, Acting Director of FDA's Center for Drug Evaluation and Research (CDER). "FDA is providing the public information based on the latest available scientific data to guide the careful and appropriate use of these drugs aimed at maximizing their potential benefits and minimizing their risks."

FDA has asked Pfizer, Inc. to withdraw Bextra (valdexocib) from the market because the overall risk versus benefit profile for the drug is unfavorable. FDA has also asked Pfizer to include a boxed warning in the Celebrex (celecoxib) label. Pfizer has agreed to suspend sales and marketing of Bextra in the U.S., pending further discussions with the agency. Pfizer has agreed to work with FDA on the boxed warning for Celebrex. FDA is asking manufacturers of all other prescription NSAIDs to revise their labels to include the same boxed warning highlighting the potential for increased risk of cardiovascular (CV) events and gastrointestinal (GI) bleeding associated with their use. Manufacturers of Celebrex and all other prescription NSAIDs will be asked to revise their labeling to include a Medication Guide for patients to help make them aware of the potential for CV and GI adverse events associated with the use of this class of drugs.

In addition, FDA is asking the manufacturers of all OTC NSAIDs to revise their labels to include more specific information about the potential CV and GI risks, and information to assist consumers in the safe use of the drugs. FDA is also asking manufacturers of OTC NSAIDs to include a warning about potential skin reactions. The labeling of the prescription NSAIDs already addresses potential skin reactions.

This current reexamination of the CV risks of NSAIDs began after Merck conducted a voluntary worldwide withdrawal of its COX-2 selective NSAID, Vioxx (rofecoxib), in September 2004. FDA will carefully review any proposal from Merck for resumption of marketing of Vioxx.

These actions are based on the available scientific data, including data accumulated since the drugs were approved. The FDA has carefully considered the presentations, discussions, and recommendations from the joint meeting of the Agency's Arthritis and Drug Safety and Risk Management Advisory Committee held on February 16-18, 2005.

To inform the public and healthcare community of its decisions, FDA today issued a Public Health Advisory (PHA) and updated patient and healthcare practitioner fact sheets.

Puerto Ricans Not Adequately Warned On Vioxx Dangers

2005-03-18T14:09:00.000-05:00

According to the Consejo de Latinos Unidos (Council of United Latinos) Merck did not provide adequeate warning about the dangers of Vioxx.

"The tragedy in Puerto Rico is that many patients took the product without knowing the risks of heart attack or stroke," executive director K.B. Forbes said Thursday. The advocacy group presented a report on Vioxx in San Juan, Puerto Rico which said in part,

"Merck appears not to have adequately informed the public or medical community in Puerto Rico of the cardiovascular dangers of Vioxx, even after the (Food and Drug Administration) called on them to do so in late 2001."

Vioxx Warnings in English Only
"We believe that in 2002 Merck should have aggressively informed physicians and patients in Puerto Rico about the risks associated with Vioxx in Spanish- language materials," Forbes said. "This oversight, this possible negligence, may have also impacted other Hispanic strongholds in the United States."

New information was added to the Vioxx labels, but these new labels and doctor information were published in English in Puerto Rico. Spanish is the most common language spoken in the U.S. territory.

Related articles: Foreign Vioxx Lawsuits Continue to Grow and New Zealanders File Vioxx Lawsuits

Vioxx Danger Buried by Merck

2005-03-09T11:04:00.000-05:00

The following article is published here with permission, was written by Mike Adams and was first published at News Target. The opinions expressed in the article are those of the author.

Merck caught in scandal to bury Vioxx heart attack risks, intimidate scientists and keep pushing dangerous drugs; Vioxx lawsuits now forming

The truth has finally come out about Vioxx: insider emails published by the Wall Street Journal reveal that Merck, the maker of Vioxx, was fully aware of the health risks of its COX-2 inhibitor anti-inflammatory drug as early as March, 2000. As is apparent from the published emails, there was a concerted effort to bury the negative evidence and even distort the drug trials by excluding heart patients from the Vioxx studies so that, "...the rate of cardiovascular problems for Vioxx patients would not be evident."

This has all been revealed now, thanks to the publication of Merck's own insider emails. One email, authored by Edward Scolnick, chief of research for Merck, says that cardiovascular risks, "...are clearly there." Additional emails contribute to the evidence that points to a fairly straightforward case of consumer deception.

Statements from several of these emails were recently published in a scathing article at the Wall Street Journal, which wrote, "Merck's first worry, in the mid-to-late 1990s, was that its drug would show greater heart risk than cheaper painkillers that were harsh on the stomach but were believed to reduce the risk of heart attacks. Several company officials discussed in e-mails how to design a study that would minimize the unflattering comparison, even while admitting to themselves that it would be difficult to conceal."

Even the medical journals are astonished at Merck's behavior. Dr. Richard Horton, editor of The Lancet (one of the most respected journals in the world), says, "the licensing of Vioxx and its continued use in the face of unambiguous evidence of harm have been public health catastrophes. This controversy will not end with the drug's withdrawal. Merck's likely litigation bill is put at between $10bn and $15bn. The company has seen its revenues and its capitalization slashed. It has been financially disabled and its reputation lies in ruins. It is not at all clear that Merck will survive this growing scandal."

Merck threatens scientists to suppress anti-Vioxx information

Merck has even been caught red-handed trying to suppress negative information about its drugs. Gurkirpal Singh, a Stanford University researcher, was threatened by the company and told he would "flame out" (meaning his career would be ended) unless he stopped giving "anti-Merck" lectures. This has now been revealed in a letter of complaint written to Merck by Dr. James Fries, a Stanford University Medical School professor, who went on to say, as reported in the Wall Street Journal, "There is a line that you can't go across. ... It had gone over that line."

And it wasn't just Stanford University, either: chief researchers at several top medical schools were being threatened by Merck. Dr. James Fries called it, "a consistent pattern of intimidation of investigators by Merck."

Merck's Chief Executive Raymond Gilmartin, in response, says it the firm has "a deep and abiding commitment to the highest ethical standards in all our dealings with physicians and other healthcare providers." Sure it does. And Vioxx is good for you, too.

As if all this wasn't enough, a Merck training manual was developed and distributed to help company officials fend off criticisms about Vioxx and instill pro-Vioxx propaganda in the minds of doctors. The document listed questions about the safety of Vioxx and said in capital letters, "DODGE!" Internally, it was even called the "Dodge Ball Vioxx" document. The primary purpose of the document was to convince doctors to keep prescribing Vioxx, even while evidence of the drug's dangers mounted.

Classic Big Pharma behavior

What does all this add up to? It's Big Pharma as usual, folks: distorted clinical studies, lying to consumers, threatening critics, burying negative evidence and all the while heavily promoting the drug to physicians and consumers. This is exactly what I've been talking about all along. These companies are knowingly harming patients just so they can keep selling dangerous drugs to a population that's generally too uninformed to know any better. And most conventional physicians just kept on prescribing the drug, oblivious to the true causes of disease or health.

Given all the damning evidence about Vioxx and its handling by Merck, does the company apologize and try to make amends? Of course not. Merck said in a recent news release that it "acted responsibly and appropriately as it developed and marketed Vioxx."

See, it's not just that these pharmaceutical companies act with reckless endangerment to the public, it's also the stunning fact that they don't see anything wrong with it. They will develop a dangerous drug, distort the clinical trials, lean on the FDA for approval, threaten scientists who speak out against the drug, and finally when the body bags start mounting, they'll claim they are innocent and have been acting ethically and honestly all along.

Dangerous drugs still generate profits

Yet the pattern of exploiting the public for profit is quite clear. An email authored by Dr. Scolnick, Merck's research chief, during the development of Vioxx reveals that even though the drug was known to be dangerous, it was bound to be a great seller just like the company's other drugs which, he admitted, are also dangerous: "We have a great drug and like angioedema with vasotec and seizures with primaxin and myopathy with mevacor there is always a hazard. The class will do well and so will we."

By saying, "The class will do well and so will we," he clearly means that despite the health hazards of the drugs, they're going to sell well anyway, and everyone who owns stock at Merck (or who works at Merck) is going to financial benefit from that.

Even prestigious medical journals (which are funded primarily by drug advertising money, by the way), joined in pumping up the credibility of Vioxx. In November, 2000, the New England Journal of Medicine published an article written by academics who were literally paid by Merck. This article heralded the "benefits" of Vioxx in reducing stomach problems and -- get this -- reducing heart attack rates. The article, of course, left out all the negative information about Vioxx, including what was obvious even in 2000: that Vioxx increased the risk of heart attacks, strokes and blood clots, even in healthy people.

The FDA: asleep at the wheel

For its part, the FDA does nothing to protect consumers. As always, the agency ignored the dangers of prescription drugs and, for many years, continued to allow Merck to keep pushing this dangerous drug right up to the day the evidence was undeniable and the drug was finally pulled. The behavior of the FDA was so irresponsible (if not downright criminal) that it earned itself scathing criticism from The Lancet, where Dr. Horton explained, "This discovery points to astonishing failures in Merck's internal systems of post-marketing surveillance, as well as to lethal weaknesses in the U.S. Food and Drug Administration's regulatory oversight." (Emphasis added.) This phrase, "lethal weaknesses," has never before been used to describe the FDA... at least not by anybody in the medical industry. It means, simply stated, that the FDA's mistakes are killing people.

In effect, the FDA acted as a Big Pharma propaganda machine, catering to the interests of drug companies at every turn. In 2001, when the FDA became increasingly aware of the dangers of the drug, it went to Merck and asked the company to include prominent new warnings on the drug label. Merck balked and complained that the FDA should, instead, highlight the drug's positive gastrointestinal features. Instead of demanding the inclusion of the warning label (like a fully empowered regulatory body might do), the FDA caved in and actually reached a compromise with Merck that resulted in a new label promoting the claim that Vioxx would caused fewer stomach upsets! Below that claim, in small print, it mentioned that the drug would also cause more heart attacks and strokes.

Meanwhile, people were dying. How many people were harmed or killed in those four years during which Merck and the FDA hid the truth about Vioxx? And how many other drugs are just as dangerous and yet heavily promoted? According to the American Medical Association, prescription drugs kill -- yes, kill -- 100,000 Americans each year. Another document, Death by Medicine authored in part by Dr. Gary Null, shows as many as 750,000 people being killed each year by medications and surgical procedures combined. Clearly, these deaths dwarf the fatalities caused by terrorists, wars, and all national crime statistics combined.

Drug companies far more dangerous than terrorists

It leads to a startling, but true, conclusion: drug companies are killing far more Americans than all terrorists, murderers and criminals combined, and yet the deaths are allowed to go on thanks to a Bush Administration that's closely allied with Big Pharma and a Food and Drug Administration that might as well be called the "Drug Promotion Agency."

"the FDA continues to see the pharmaceutical industry as its customer -- a vital source of funding for its activities -- and not as a sector of society in need of strong regulation." - Dr. Richard Horton, editor, The Lancet

Outraged

I'm outraged by this. I'm outraged by the pain, suffering and fatalities that are caused every day by prescription drugs. I'm outraged by the behavior of the FDA and its campaign to discredit herbs and vitamins while ignoring far more dangerous prescription drugs. I'm outraged by the drug company executives who earn millions of dollars each year peddling dangerous drugs to elderly people who have to choose between food and medicine because they can't afford the sky-high prices of prescription drugs. I'm outraged by the FDA's efforts to monopolize the U.S. drug market, ban drug imports from Canada, and force senior citizens to pay ridiculous prices for deadly drugs. And I'm outraged by a national media that's so tied to drug company advertising revenues that we'll probably never be able to repeal direct-to-consumer advertising (which is partly responsible for this Vioxx mess).

It's time for serious action. It's time to go after these criminal pharmaceutical executives and charge them with the crimes they have committed against humanity. It's time to hit these companies where it hurts: right in the pocketbook. It's time to put Merck and its competition out of business for good... and thereby save the lives of untold Americans who can be spared the harm caused by prescription drugs.

And here's how I'm going to help make that happen:

For the first time ever, I am publicly supporting legal action against a pharmaceutical company. Today, I am announcing that I will assist individuals who were harmed by Vioxx in filing lawsuits against Merck for the damage caused by their products. I'll do this by getting you in touch with capable legal teams who are involved in ongoing legal action against the pharmaceutical giant. So if you've taken Vioxx and want to join what could become a multi-billion-dollar settlement against Merck, contact us at feedback48@newstarget.com and include your name and address. We'll forward your information to a legal team who will take it from there. (We're doing this at no charge, and without any financial compensation of any kind.)

Or, you can search on Google or some other search engine and find a legal team yourself. Whatever you do, don't sit back. This is not just about getting a financial reward for yourself, this is about bankrupting an evil empire that is knowingly damaging the health of millions of people in order to make a buck. And these "smoking gun" emails are probably just the tip of the iceberg. Who knows how many more evils are taking place behind closed doors at Merck and other companies, where the business philosophy seems to be, "profits at all costs!" Ethics be damned. These companies are going to sell you drugs that may, indeed, kill you. And they're going to keep raising the prices each year, too, so you have to pay more even while you continue to be harmed. It is unethical, unjust, and unacceptable.

It's time to stand up and take action. If you've been harmed by Vioxx, I urge you to demand justice and join the legal action against Merck. Let's put this company out of business for good and send a message to Big Pharma that they can no longer exploit Americans' health for their own corporate greed.

Related information: How to Select a Vioxx Attorney

FDA Panel Biased in Vioxx, Celebrex and Bextra Decisions?

2005-03-02T09:23:00.000-05:00

An FDA panel of scientists and doctors recently voted to keep Celebrex and Bextra on the market and to allow for a possible return to the market for Vioxx. The FDA typically follows recommendations of its advisory panels and these decisions were widely seen as a victory for both Merck and Pfizer.

With Vioxx and Celebrex lawsuits increasing daily, both Merck and Pfizer were looking for any edge they could get. The fact that the FDA panel did not remove the products from the market and in fact voted to return Vioxx to the market meant that lawyers could point to the panel decision and say, "The FDA didn't find a serious problem here - these products must be OK!" Attorneys for Merck and Pfizer were elated with the decisions. Attorneys for Vioxx and Celebrex plaintiffs were troubled. Their lawsuits just became more difficult to win.

However, as is usually the case when discussing lawsuits that involve huge sums of money, not everything is quite as simple as it appears. The New York Times asked the Center for Science in the Public Interest to look into the panel to see if there were any conflicts of interest. The results of the research showed that 10 of the 32 panel members were paid consultants for either Pfizer or Merck. Further analysis showed that if those 10 panelists had not voted, the committee would have rejected future sales of Bextra and Vioxx.

"Votes are tainted", Sen. Charles Grassley
"Unfortunately, the votes ... are now, justly or unjustly, tainted," said Iowa Republican Sen. Charles Grassley, chairman of the Senate Finance Committee.

With this information now out in the open, what had appeared as a victory for Merck and Pfizer, is a hollow victory at best. If they try to use the decision of the FDA panel in court, the plaintiff lawyers will point out the there was a clear conflict of interest and that the findings of the panel have no merit.

The FDA had been looked upon as a source of information. Information that could make or break the pending Vioxx, Celebrex and Bextra lawsuits. Unfortunately, once again, the FDA was not up to the task.

Related story: Vioxx Inquiry Panel Biased?

More Vioxx News: Conflict of Interest on COX-2 Panel

The Vioxx Saga - A Daughters Concern

2005-02-25T09:38:00.000-05:00

The following is a thought provoking letter written to Elites TV, who have been kind enough to allow it to be re-published here. This is not the kind of article that you usually find on this site. It is not about Vioxx lawyers or class action lawsuits. It's about someone that wanted to help out, someone that wanted to do the right thing and the consequences of that decision.

***

"Last year, my 80-year-old mother underwent knee replacement surgery. She was in otherwise good health, and decided to have the surgery to improve the quality of her life. The old knee had made walking difficult, and her doctor assured her that a replacement would give her back the ability to walk and exercise with much less pain and effort.

The surgery was successful, and after a few days in the hospital, she was released to a rehabilitation center where she was to stay for a week to receive some therapy. She is a determined woman and wanted to get back on her feet, literally.

But things didn't quite go as planned. A few days into her stay, she began complaining of pain in the knee and noticed some swelling. Medical personnel assured her that this was normal, but as the swelling and pain increased, she knew instinctively that something was wrong.

Finally, a doctor was called in to look at her knee and realized that this swelling was not routine. She was rushed back to the hospital where doctors confirmed that she had developed a blood clot, which had it dislodged, would have most likely had dire effects, and might even have killed her.

She was confined to bed rest, given blood thinners and her recovery was set back two weeks. Once she was released, she had to endure more therapy but the knee had already set up and even now, a year later, she is still not able to use it normally.

Why did this happen? The doctors had no answers, but when her history was studied, they determined that it may have been due to her participating in a drug trial several years prior. She had been in a test group for Vioxx, but never learned whether she had been given the drug or a placebo. Those records weren't available but, considering what has been learned about this drug since, it is not a stretch to think that this was the case.

How many people participate in trials without knowing the drug that they were given? If those people ultimately suffer side effects, do they have any recourse? This is an area that has received little publicity but certainly opens up a new area of discussion. At the least, potential subjects might want to think twice before taking part in such a study.

It is understandable that patients might want to be part of a study. Arthritis sufferers will go to any lengths to find relief, even if for a short time. And certainly, these drugs are effective. But at what cost?

My mother has had to give up taking any kind of arthritis pain medication for over a year and continues to take blood thinners to prevent clots. She can't even go to the dentist for fear of bleeding. This vital woman who thought she was going to be improving the quality of her life is now angry and discouraged, and still in pain. There is no recourse, but she hopes that her experience can alert others to at least ask the hard questions when participating in these trials. Understandably, she is reluctant to have the other knee done and is willing to live with the pain rather than risk death.

In an age where people are suing for being injured by coffee that is too hot, one wonders how these companies protect themselves from litigation during these trials. Participants sign lots of forms, acknowledging their risk and signing away their rights to sue. But, for a daughter who loves her mother, no amount of money could have compensated for the loss of her mother, if the worst had happened. Thankfully, she survived this. But how many do not, and is it worth it?"
D.R. Boyer

Re-published with the permission of Elites TV

Celebrex and Bextra Warnings Issued in Germany and New Zealand

2005-02-22T16:37:00.000-05:00

Celebrex and Bextra Dangers Prompt New Warnings
The New Zealand Ministry of Health has issued a strong warning related to the Cox-2 painkillers Celebrex, Bextra and Arcoxia. It says the increased risk of heart attack and stroke outweighs the benefits.

Ministry spokesman Dr Stewart Jessamine says they do not have enough information yet to quantify the risk, but their preliminary conclusion is that all Cox-2 inhibitors may increase the risk in some patients.

In Germany, the regulatory body BfArM announced that patients who either have had a heart attack or stroke, suffer from circulatory disorders of the heart or are at a high risk of developing such conditions should no longer use the medications. They have announced that they will introduce new restrictions covering the use of COX-2 inhibitors, such as Pfizer's Bextra and Celebrex and Merck & Co's Arcoxia.

In the new product guidelines, it will be pointed out that the use of COX-2 medications should be limited to the lowest effective dosage and for only so long as is absolutely necessary.

Related story: FDA Votes to Keep Vioxx, Celebrex and Bextra on the Market

FDA Votes to Keep Vioxx, Celebrex and Bextra on the Market

2005-02-22T12:25:00.000-05:00

Celebrex and Bextra Stay - Vioxx may Return
This past week, a special panel of 32 scientists was assembled by the FDA to examin the safety of the COX-2 drugs Vioxx, Celebrex and Bextra. After hearing testimony from many witnesses including doctors, scientists and drug manufacturers, the panel voted to allow Celebrex and Bextra to remain on the market. They also made provision for Vioxx to be returned to the market. (Vioxx was recalled in September, 2004)

All three of these drugs have been linked in various studies with patients suffering serious heart complications including heart attacks and strokes. The move to allow these drugs to remain on the market was not without controversy.

Consumer advocate Sidney Wolfe of Public Citizen said, "This was a very bad decision," and added that Vioxx's effectiveness "is swamped by the dangers."

Alistair J. J. Wood of Vanderbilt University, a pharmacology professor who chaired the joint meeting, said, "The data are very compelling. Vioxx is substantially worse than the others."

On the positive side, Pennsylvania epidemiologist John T. Farrar, said, "The absolute increase in risk is not such that these drugs should be pulled out of the hands of wise physicians and informed patients as though there is a smoking gun."

Warning Labels on Celebrex and Bextra
The panel also recommended several measures designed to increase patient and doctor awareness of the dangers of the drugs.

Their suggestions included placing a prominent "black box" warning on the drugs' packaging, including more patient information, restricting which patients could get them, and banning direct to consumer advertising.

Related Story: Doctors in Pain over Vioxx

Drug Oversight Safety Board Created

2005-02-15T19:20:00.000-05:00

One day before the FDA begins it's investigation into the COX-2 drugs, Vioxx, Celebrex and Bextra the creation of a new independent monitoring board within the FDA has been announced. The Drug Oversight Safety Board, is being formed and will be comprised of experts from the FDA, research groups, patients and consumer advocates. The board will recommend what information and updates to put on the government's Drug Watch, resolve disputes over drug safety issues, and oversee the development of a drug safety policy.

"The public has spoken and they want more oversight and openness," said Health and Human Services Secretary Mike Leavitt on Tuesday. "They want to know what we know, what we do with the information and why we do it."

Safety Board Designed to Eliminate Vioxx Type Problems
Sen. Charles Grassley, (D-Iowa) said, "It also remains necessary that the drug safety office within the FDA be made a truly independent entity from the office of new drugs. I'm drafting legislation to clearly establish this independence and provide the office the authority needed to do its job."

"The steps announced today ... are an overdue step forward, but they don't go nearly far enough. It is critical that FDA's resources to monitor drugs be dramatically increased, and the FDA must be given the authority to require drug companies to initiate and complete appropriate safety studies," said Sen. Edward Kennedy, a critic of the Bush administration's handling of the FDA.

Related story: FDA to Probe Vioxx, Celebrex and Bextra

Vioxx Bombshell to be Revealed to FDA

2005-02-15T17:57:00.000-05:00

A News Advisory from the Pysicians Committee for Responsible Medicine, states that John J. Pippin, M.D., FA.C.C will testify Thursday before the FDA and "present a new report detailing how experiments on mice, dogs, and other animals misled scientists and ultimately contributed to a tragic outcome for human patients exposed to Vioxx and other drugs."

The report further states, "PCRM's report reveals that Vioxx and other COX-2 drugs actually had a heart-protective effect in mice and other animals, exactly opposite of how the drugs later performed in humans. The report also reveals that once clinical trials started showing that the drugs caused heart problems in humans, the pharmaceutical companies ignored this information and instead pointed to the animal tests as "evidence" that the drugs were safe. As Dr. Pippin illustrates in the report, the Vioxx animal testing debacle is not unique. Over the years, millions of patients have been exposed to harmful drugs, such as Rezulin and Baycol, that seemed safe in tests on mice, dogs, rats, monkeys, horses, and other animals.

"Reliance on animal tests enabled the FDA to approve Vioxx," says Dr. Pippin. "It is time to turn to newer, more reliable human-based methods such as studying drug metabolism using human liver subcellular fractions." Liver toxicity is the major reason for drug re-labeling and withdrawal, and it often does not show up in dogs and other animals.

In three days of hearings, beginning this Wednesday, the FDA and a panel of outside experts will investigate the safety of arthritis drugs called Cox-2 inhibitors. This group includes Vioxx, Celebrex, and Bextra.

Related story: FDA to Probe Vioxx, Celebrex and Bextra
Contact: Jeanne Stuart McVey of the Physicians Committee for Responsible Medicine, 202-686-2210, ext. 316 or 415-509-1833 (cell), jeannem@pcrm.org

Australia Places Warning Labels on Celebrex, Bextra

2005-02-15T00:34:00.000-05:00

According to an article by Rita Rubin, in USA Today, Australia's Therapeutic Goods Administration has ordered the makers of COX-2 drugs (including Celebrex, Bextra) to place a boxed warning on their labels, advising patients about the increased risk of cardiovascular problems. The agency is further advising patients who take more than 200 milligrams a day of Celebrex to discuss their treatment regimen with their doctor.

Bextra May Not be Approved
The Australian agency also has proposed withdrawing its approval of Bextra for the treatment of arthritis. Bextra has not yet been approved for use in Australia.

In other news, results of a study that "pooled the results of 19 trials comparing COX-2 inhibitors with a placebo or conventional pain reliever, such as ibuprofen or naproxen", showed that Vioxx raised blood pressure more than Celebrex. This increase in blood pressure "requires caution in their use and warrants further investigation," the authors write.

For the complete story: Australia puts Warning Labels on Celebrex and Bextra
Related story: FDA to Probe Celebrex and Bextra

Will Celebrex and Bextra be Recalled?

2005-02-12T19:25:00.000-05:00

Future of Celebrex, Bextra to be Decided at FDA Meeting
The fate of an entire class of drugs (COX-2 drugs, Celebrex, Bextra) is likely to be decided at a meeting of the FDA's Drug Safety & Risk Management Advisory Committee this week.

The COX-2 drugs, Vioxx, Celebrex and Bextra were developed to be effective painkillers that did not cause bleeding, stomach ulcers and other serious digestive tract complications. Older nonsteroidal anti-inflammatory drugs such as ibuprofen killed the pain but often were the cause of intestinal problems.

Aggressive marketing to physicians and "direct to patient' advertising made Vioxx, Celebrex (and Bextra to a lesser degree) huge successes. Unfortunately, the COX-2 inhibitors have never been shown to be more effective than conventional NSAIDs and reports of serious heart complications associated with Vioxx, forced it's recall. More reports of side effects associated with Celebrex and Bextra have prompted this three day meeting of the FDA Arthritis Drugs Advisory Committee.

Chief of rheumatology at Presbyterian Hospital of Dallas and Arthritis Advisory Committee member John Cush, says he's hoping that "some appropriate and proper guidance comes out of this." Patients and doctors everywhere agree.

Related article: Study May Speed Recall of Celebrex and FDA Probes Celebrex, Bextra

Major University Advises Patients to Avoid Celebrex, Bextra

2005-02-08T16:23:00.000-05:00

An article in the Opelica-Auburn News by Jack Stripling says that Auburn University’s Pharmaceutical Care Center has advised patients to avoid taking the controversial medications Vioxx, Celebrex and Bextra.

Since the Vioxx recall, questions are being raised about the safety of two other drugs - Bextra and Celebrex - part of the COX-2 family of medications.

Are Vioxx, Celebrex and Bextra All the Same?
"We might find that all COX-2 inhibitors have the same risk,” said Dr. Kimberly Braxton Lloyd, director of AUPCC.

Vioxx, Celebrex and Bextra were developed to deliver pain relief like aspirin and ibuprofen but without the nasty side effects of gastrointestinal bleeding. But according to a newsletter published by the AUPCC, "drug manufacturers tweaked the drugs to reduce stomach pain, but in so doing inhibited a chemical in the body that promotes blood flow. The result? Blood vessels narrow and platelets clump which increases the risk of heart attacks and strokes."

The article goes on to say that a bad situation was made worse by all the 'direct to consumer' advertising. "The negative side of it is you may have people coming in and asking for medications that aren’t appropriate for their conditions,” said Dr. Kem Krueger, associate professor in AU’s School of Pharmacy.

“The FDA was not quick enough to act on this potential problem or to identify it,” Krueger said. “I don’t know if it’s shaken confidence to the core,” he added. “But it’s made us question.”

For the complete story: Patients Should Avoid Celebrex, Bextra

Can Vioxx Problem Force Bankrupcy?

2005-02-07T09:56:00.000-05:00

Vioxx Class Action Suits Increase Pressure on Merck
When Merck CEO, Raymond Gilmartin was asked if Vioxx litigation would bankrupt the huge drug maker, his answer was, "Absolutely not, anyone who looks at the strength of our balance sheet and our cash flow will see that."

However, some financial analysts feel differently, for these reasons:

*** Vioxx litigation costs will be high. An estimated 700 Vioxx lawsuits have been filed and more are expected. The number of actual Vioxx class action plaintiffs is now estimated in the tens of thousands.

*** Merck's Vioxx liabilities are potentially very high. Depending on the actual number of plaintiffs and the number of class action suits that are won by plaintiffs, estimates of Vioxx liabilities range from $18 billion to over $50 billion.

*** Merck has made no provisions whatsoever for its Vioxx liabilities. Management at Merck apparently believes that class action and individual settlements can be drawn out for an extended period of time. This may allow them to pay out damage awards from future cash flow.

Vioxx Litigation may Cost Billions

There is one thing that may save Merck and several other pharmaceutical giants including Pfizer Inc. (Celebrex, Bextra) and that is President Bush. Bush is promoting a piece of legislation, that if it becomes law, would restrict a citizens right to sue and would limit the amount off damages paid. The drug companies contributed huge sums of money to the Republican party in the last election. There are many that believe the president is running the best government that money can buy. Don't bet on Bush siding with the rights of the individual ahead of the needs of corporate America.

Related Articles: Vioxx, Celebrex Users Lose Rights and Bush Protects Makers of Vioxx, Celebrex

Vioxx, Celebrex Safety Concerns

2005-02-04T13:19:00.000-05:00

Vioxx, Celebrex and Bextra Alternatives Sought
When Vioxx was recalled from the market in September of 2004 many patients throughout the U.S.A. and worldwide went looking for a new painkiller. Some of them were advised by their doctors to return to the old standbys, Aspirin, Advil or Tylenol. But many switched to the other COX-2 drugs, Celebrex and Bextra.

Now, with recent studies being made public, questions are being asked about the safety of Celebrex and Bextra. The FDA will hold an unprecedented three day inquiry into the dangers of Celebrex and Bextra. All advertising for Celebrex has been halted.

The many people suffering and in pain must find a safe solution, but medications once thought to be safe are suddenly unavailable. So, what choices do you have?

Speak to your doctor. Get your doctor to explain the pros and cons of the individual medications so that you understand all the risks associated with using these painkilling drugs. Ask questions like:

** What painkilling drug are you recommending?
** How long has the drug been on the market?
** What particular problems are associated with the drug?
** What side effects have been reported?
** What side effects have you seen personally?
** How much experience do you have prescribing this drug?

Unfortunately, being confused about which drugs are safe is a rather normal state these days. Many people feel that the FDA has let them down and now the Bush government wants to limit damage suits against the pharmaceutical companies. Bookmark this page and return often. We will keep you up-to-date with all the latest information. Being informed is your best option.

Related article: Celebrex Risk

Pfizer Defends Celebrex

2005-02-02T13:00:00.000-05:00

Pfizer Refutes Celebrex Claims by Public Citizen
Responding to another petition for the recall of Celebrex by the consumer group Public Citizen on Monday, officials at Pfizer issued a press release today.

Pfizer vigorously refutes claims by Public Citizen that safety data from a 1999 Celebrex study in Alzheimer's patients were "undisclosed." The study was monitored by an independent panel of safety experts, an abstract of the results was presented at a scientific congress in 2000, and the completed study report was submitted to the FDA in June 2001.

"Pfizer acted responsibly in sharing this information in a timely manner with the FDA," said Dr. Joseph Feczko, Pfizer president of worldwide development.

"Public Citizen’s cherry-picking of data is alarmist and misconceived,” he said. “It is not possible to draw clinically meaningful cardiovascular conclusions from this study alone given the variations in patients’ medical history, their advanced age and other significant study limitations. This flawed use of data is misleading and unfair to a reasoned scientific discussion of these issues.”

The release further states that there was a large difference in the "underlying cardiovascular risk profile of the patients assigned to Celebrex treatment compared with those who received placebo." and that "Even Public Citizen acknowledged the study "was not large enough to demonstrate a statistically significant increase in any individual serious cardiovascular event."

The release concludes by stating that "the upcoming FDA advisory meeting is the appropriate forum for these important public health issues to be fully addressed and put into context.”

Full press release: Pfizer Defends Celebrex

Canadian Study Finds No Heart Risk with Celebrex

2005-02-01T09:42:00.000-05:00

Increases in Heart Risk with Vioxx but not Celebrex

A major study done at Canada's McGill University in Montreal has concluded that patients taking Vioxx were at incresed risk of heart attack and stroke. The study included 113,927 older residents of Quebec and found incidence of heart attacks increased 21 percent among those who took low doses of Vioxx and by 73 percent in those who took high doses.

"This is consistent with what most of the other studies have found," said study author Dr. James A. Brophy, an associate professor of medicine at McGill. "But it included many more cases than other studies, so we were able to have more precision. And other studies have not demonstrated dose-dependency."

Increased Risk Not Found with Celebrex
Another interesting conclusion from this study is that no similar increase in risk was found for Celebrex. Celebrex, like the recalled Vioxx is a member of the cox-2 inhibitor family of drugs.

"The importance of the new study is that it separates Vioxx from other cox-2 inhibitors," said Dr. Todd Schlifstein, an assistant professor of rehabilitation medicine at New York University School of Medicine. He called it "an impressive study because of its vast size and the number of years over which it was done."

Study results appear in the Feb. 1 online edition of the Annals of Internal Medicine.
Related story: FDA to Probe Celebrex, Bextra

Bextra Banned by Kaiser Permanente

2005-01-29T15:25:00.000-05:00

Could Celebrex be Next?

The controversial COX-2 drug Bextra has been banned by one of the nation's largest managed care organizations. In a move that is unprecedented, Bextra has become the first drug approved by the Food and Drug Administration to be banned by Kaiser Permanente.

Dr. Sharon Levine, associate executive director of the company's Northern California unit said that Kaiser physicians had already avoided using the drug. But "for safety and quality reasons, we don't want to be involved in dispensing this drug," she said.

Dr. David Campen, Kaiser's medical director of pharmacy services, said yesterday, Kaiser doctors will continue prescribing Celebrex. At low doses, "Celebrex does not appear to have the same risks as Bextra or Vioxx", Dr. Campen said.

"But clearly at the higher dose levels, there does seem to be a problem" with Celebrex, he said.

Both Celebrex and Bextra offer no unique benefits but plenty of possible risks. Clinical trials have found that Celebrex and Bextra cure pain no better than older medicines like ibuprofen and claims that they are safer on the stomach than older medicines have never been proven.

Related story: FDA Probes Celebrex and Bextra Safety

SEC to Investigate Vioxx Withdrawl

2005-01-28T14:33:00.000-05:00

In a press release issued today, Merck and Co. announced that notification has been recieved from the Securities and Exchange Commission that there would be a formal investigation into the Vioxx problem.

It is believed that the inquiry will center around whether Merck disclosed enough information about Vioxx. News of the SEC inquiry sent Merck shares falling again, this time by $2.53, or 8 percent, to $28.65 after falling as low as $28.32.

The Merck press release says that the SEC move 'wasn't unexpected', and notes that a formal probe gives the SEC staff the power to issue subpoenas for documents or testimony. Merck is also being probed at this time by the Department of Justice and certain Congressional committees.

Vioxx Problem Multiplies for Merck

Food and Drug Administration safety reviewer David Graham said in a study published this week by the U.K. medical journal Lancet that Vioxx may have caused as many as 140,000 heart attacks in the U.S. The Vioxx problem could become the single largest product safety lawsuit in history, with some estimates putting the number of plaintiffs in the tens of thousands.

Related story: European Agency to Probe Vioxx Problem

Can a Celebrex Class Action Lawsuit be Won?

2005-01-26T11:08:00.000-05:00

With the furor surrounding the Vioxx recall and new test results that show possible dangers of the drugs Celebrex and Bextra, many people are thinking about lawsuits. In fact, hundreds of Vioxx class action suits have already been filed against Merck. However, the cases are not the same and with regard to Celebrex and Bextra the question to be answered is - can a Celebrex class action suit be won?

Many people feel that since Vioxx, Celebrex and Bextra are all COX-2 type drugs that the cases against Pfizer (Celebrex Bextra) will be the same as those against Merck (Vioxx). However, there are two distinct differences. First, the FDA has not yet recalled Celebrex or Bextra,(an FDA recall would certainly strengthen plaintiff cases) and second, the evidence in the Vioxx cases appears to be much stronger.

Is there enough evidence to win a Celebrex Class Action Lawsuit?

Now this is not to say that there shouldn't be a recall of Celebrex and/or Bextra or that these medications didn't harm some patients. In fact there are many individuals and groups that are calling for the recall of Celebrex and Bextra. In fact, the public health group 'Public Citizen' recently petitioned the FDA to ban both drugs.

Pfizer's position on the matter of a recall is quite clear. They say that Celebrex and Bextra are not chemically the same as Vioxx. They say that results of clinical studies vary greatly and that the evidence that Celebrex and Bextra pose a danger, is not conclusive.

Complicating the picture even more is President Bush's proposed legislation that would protect the pharmaceutical giants against class action suits. Bush wants to limit the amount of awards and damages paid to plaintiffs. If this legislation becomes law, the question of winning a lawsuit against any of the drug companies will become moot. Your right to sue will be severly limited.

Todd A. Smith, President of the Association of Trial Lawyers of America said, "President Bush unashamedly advocates legislation that would protect insurance industry profits and prohibit any punishment for the makers of dangerous drugs like Vioxx."

Many Celebrex class action suits have not been filed due to all of this uncertainty. If you believe that you have been harmed by Celebrex or Bextra, bookmark this page to stay current with all the latest Celebrex news and read this article on selecting a Celebrex attorney.

Related article: Celebrex Class Action Lawsuit Filed in Pittsburgh

Merck's Vioxx Update

2005-01-25T14:30:00.000-05:00

Today Merck and Co, Inc. released it's 2004 full year results. Most of the information provided was expected by analysts and obviously Merck has been seriously hurt by the Vioxx recall. However there were some interesting and unexpected revelations. Here are some highlights:

*** Merck is facing three different types of lawsuits. They are Vioxx Product Liability Lawsuits, Vioxx Securities Lawsuits and Employee Retirement Income Security Lawsuits.

*** Merck is being investigated by The Securities Exchange Commision, the U.S. Department of Justice and some Congressional Committees.

*** Merck has been named as a defendant in lawsuits in Europe, Canada, Brazil, Autralia and Israel.

*** Merck believes that it's insurance coverage may not be adequate to cover its defense costs and losses.

*** Merck has not established any reserves for any potential Vioxx liability.

What follows is Vioxx information taken directly from the Merck website:

Vioxx Litigation Update

As previously disclosed, federal and state personal injury lawsuits involving individual claims, as well as several putative class actions have been filed against the company with respect to VIOXX. As of Dec. 31, the company has been served or is aware that it has been named as a defendant in approximately 575 lawsuits, which include approximately 1,400 plaintiff groups alleging personal injuries resulting from the use of VIOXX. Certain of these lawsuits include allegations regarding gastrointestinal bleeding, cardiovascular events, thrombotic events or kidney damage. The company has also been named as a defendant in approximately 70 putative class actions alleging personal injuries or seeking (i) medical monitoring as a result of the putative class members' use of VIOXX, (ii) disgorgement of certain profits under common law unjust enrichment theories, and/or (iii) various remedies under state consumer fraud and fair business practice statutes, including recovering the cost of VIOXX purchased by individuals and third-party payors such as union health plans (all of the actions discussed in this paragraph are collectively referred to as the "VIOXX Product Liability Lawsuits"). The actions filed in the state courts of California and New Jersey, respectively, have been transferred to a single judge in each state for coordinated proceedings. In addition, the company has filed a motion with the Judicial Panel on Multidistrict Litigation seeking to transfer to a single federal judge and consolidate for pretrial purposes all federal cases alleging personal injury and/or economic loss relating to the purchase or use of VIOXX; several plaintiffs in certain VIOXX Product Liability Lawsuits pending in federal court have made similar requests. The hearing on these motions will be held on Jan. 27.

Also as previously disclosed, in addition to the VIOXX Product Liability Lawsuits, a number of purported class action lawsuits have been brought naming as defendants the company and several current or former officers of the company, and alleging that the defendants made false and misleading statements regarding VIOXX in violation of the federal securities laws (the "VIOXX Securities Lawsuits"). As of Dec. 31, 14 VIOXX Securities Lawsuits have been filed. In addition to the VIOXX Securities Lawsuits, as previously disclosed, shareholders have brought derivative lawsuits against the company. As of Dec. 31, six such lawsuits have been filed. In addition, the company has received a demand from two shareholders that the Board take legal action against Raymond V. Gilmartin, chairman, president and chief executive officer, and other unspecified individuals for allegedly causing damage to the company through the allegedly improper marketing of VIOXX. Also, as previously disclosed, lawsuits asserting claims under the Employee Retirement Income Security Act (ERISA) have been brought against the company. As of Dec. 31, 10 such lawsuits have been filed. The company has filed a motion with the Judicial Panel on Multidistrict Litigation to transfer to a single federal judge and consolidate for pretrial purposes all federal lawsuits discussed in this paragraph (collectively, the "VIOXX Shareholder Lawsuits" and together with the VIOXX Product Liability Lawsuits and the lawsuits discussed in the next paragraph, the "VIOXX Lawsuits"). The hearing on this motion will be held on Jan. 27.

In addition to the lawsuits discussed above, the company has been named as a defendant in actions in various countries in Europe, Canada, Brazil, Australia and Israel related to VIOXX.

Based on media reports and other sources, the company anticipates that additional VIOXX Lawsuits will be filed against it and/or certain of its current and former officers and directors in the future.

As previously disclosed, there are investigations concerning VIOXX currently being conducted by the Securities and Exchange Commission, the U.S. Department of Justice and certain Congressional committees. Also, the District Attorney's Office in Munich, Germany has notified the company's subsidiary in Germany that it has received complaints and commenced an investigation in order to determine whether any criminal charges should be brought in Germany concerning VIOXX (together with the previously mentioned investigations, the "VIOXX Investigations").

Also as previously disclosed, the company has product liability insurance for claims brought in the VIOXX Product Liability Lawsuits of up to approximately $630 million after deductibles and co-insurance. This insurance provides coverage for legal defense costs and potential damage amounts that have been or will be incurred in connection with the VIOXX Product Liability Lawsuits. The company believes that this insurance coverage extends to additional VIOXX Product Liability Lawsuits that may be filed in the future. Certain of the company's insurers have reserved their rights to take a contrary position with respect to certain coverage and there could be disputes with insurers about coverage matters. The company currently believes that it has at least approximately $190 million of Directors and Officers insurance coverage for the VIOXX Securities Lawsuits and VIOXX Derivative Lawsuits, and at least approximately $275 million of insurance coverage for the VIOXX ERISA Lawsuits. Additional insurance coverage for these claims may also be available under upper-level excess policies that provide coverage for a variety of risks. There may be disputes with insurers about the availability of some or all of this insurance coverage. At this time, the company believes it is reasonably possible that its insurance coverage with respect to the VIOXX Lawsuits will not be adequate to cover its defense costs and losses, if any.

The company currently anticipates that one or more of the VIOXX Product Liability Lawsuits may go to trial in the first half of 2005. The company cannot predict the timing of any trials with respect to the VIOXX Shareholder Lawsuits. The company believes that it has meritorious defenses to the VIOXX Lawsuits and will vigorously defend against them. In view of the inherent difficulty of predicting the outcome of litigation, particularly where there are many claimants and the claimants seek indeterminate damages, the company is unable to predict the outcome of these matters, and at this time cannot reasonably estimate the possible loss or range of loss with respect to the VIOXX Lawsuits. The company has established a reserve of $675 million solely for its future legal defense costs related to the VIOXX Lawsuits and the VIOXX Investigations. This reserve is based on certain assumptions and is the minimum amount that the company believes at this time it can reasonably estimate will be spent over a multi-year period. In accordance with GAAP and consistent with Merck's practice, the company significantly increased the reserve when it had the ability to reasonably estimate its future legal defense costs for the VIOXX litigation based on both actual costs incurred as well as the development of its legal defense strategy and structure in light of the expanded scope of the litigation. The company will continue to monitor its legal defense costs and review the adequacy of the associated reserves. The company has not established any reserves for any potential liability relating to the VIOXX litigation. Unfavorable outcomes in the VIOXX Lawsuits or resulting from the VIOXX Investigations could have a material adverse effect on the company's financial position, liquidity and results of operations.

Related Stories: Vioxx Lawsuits Begin this Spring and Selecting a Vioxx Attorney

Celebrex Plus Warfarin Could be Deadly Combination

2005-01-25T13:49:00.000-05:00

Research done at the University of Toronto suggests that elderly patients taking the blood thinning drug Warfarin are at increased risk of upper gastrointestinal (GI) hemorrhage if they are also taking the painkilling COX-2 drugs Celebrex or Bextra.

On Warfarin and Celebrex or Bextra?

Results of this study were published in the January 25/2005 edition of the JAMA's, Archives of Internal Medicine. The study examined 98,821 elderly patient and concluded that those "taking warfarin concomitantly with selective COX-2 inhibitors have an increased risk of hospitalization for upper GI hemorrhage. The risk appears similar to that of patients simultaneously taking warfarin and nonselective NSAIDs."

For more information: Celebrex Dangers

Related Article: Celebrex and Bextra Dangers

'Public Citizen' Calls for Removal of Celebrex and Bextra

2005-01-25T01:00:00.000-05:00

According to the consumer group Public Citizen, a petition has been filed with the FDA calling for the COX-2 drugs Celebrex and Bextra to be removed from the market.

A press release issued by Public Citizen states, “If a drug offers no unique benefit compared to other drugs for treating the same problem (in this case arthritis and pain) but subjects patients to a unique risk, it must be removed from the market.”

Ban the Sale of Celebrex and Bextra

“The Food and Drug Administration should immediately ban the sale of Celebrex and Bextra, which put millions of people, many of them elderly, at risk of heart attack,” said Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group. “These drugs are not only more expensive and more dangerous than older, safer pain relievers, they are no better at protecting the gastrointestinal tract.”

"Public Citizen has a long history of identifying unsafe or ineffective drugs. Vioxx, for example, was the ninth prescription drug to be taken off the market in the past seven years that Public Citizen had previously warned consumers not to use. For four of the drugs – Vioxx, Baycol, Rezulin and Serzone – Public Citizen issued warnings more than two years before their removal from the market. Public Citizen warned patients not to use Celebrex three and half years before the government announced that a study showed increased heart risks."

Complete Press Release:Public Citizen Petitions FDA to Take Celebrex and Bextra Off the Market

Related Story: Celebrex and Vioxx Dangers

Vioxx and Celebrex Overprescribed?

2005-01-24T10:06:00.000-05:00

A study by doctors at Stanford University and the University of Chicago found that Vioxx and Celebrex were taken by millions of people who were not at risk of gastrointestinal bleeding. Aspirin and some other lower-cost painkillers can cause gastrointestinal bleeding and this was the main reason patients were told to switch to the more expensive COX-2 drugs.

The study results show that 73 percent of patients considered at low or very low risk of gastrointestinal problems should not have been considered for the newer drugs.

"We found a rapid, nationwide shift away from older, inexpensive drugs with better established safety and efficacy to newer, costly drugs with no real history," said study author G. Caleb Alexander, a medical ethicist at the University of Chicago.

Vioxx and Celebrex Overprescribed

The study also showed that by 2002, 17.6 million patients at low risk of gastrointestinal bleeding, or 66 percent of those patients, were taking one of the two COX-2 inhibitors.

Also included in the study is the alarming statistic that the drugs were taken by as many as 16 million people suffering from congestive heart failure, or liver or kidney dysfunction. Patients that clearly should not have taken Vioxx or Celebrex and might also have been hurt by these drugs.

The question being asked now is, "Who is a fault here?" The FDA, for not regulating and testing thoroughly enough? Merck and Pfizer, for advertising unsafe products directly to the public? Doctors, who felt that newer was better? Perhaps all of the above . . .

Related article: Vioxx and Celebrex Dangers

Illinois Vioxx Suit Filed

2005-01-24T09:30:00.000-05:00

An article in the Madison-St.Clair Record by Steve Gonzalez says that the first Vioxx lawsuit in Madison County claiming damages, has been filed by David J McQuay.

McQuay claims that he was unaware of the dangers of Vioxx and that at the time Vioxx was sold to him it was "defective in design and unreasonably dangerous, subjecting him to risks of heart attack, strokes and other illnesses."

"Vioxx possessed serious life threatening side effects. . ."

Mr. McQuay is represented by attorneys Jeffrey Lowe, Joseph P. Dani and Evan Buxner and has also claimed that adequate testing was not done by Merck and that "Vioxx possessed serious life threatening side effects. . ."

The claim further states that, "Merck failed to warn users and doctors that numerous other methods of pain relievers, including Ibuprofen, Naproxen and Mobic were safer."

Mr. McQuay has developed heart disease and has undergone quadruple heart bypass surgery.

Related article: Can Vioxx Suits be Won?

Vioxx Attorneys Meet in Philadelphia

2005-01-21T14:53:00.000-05:00

It must have looked like a scene from a John Grisham novel, 250 lawyers crowded into Philadelphia's Wyndham Hotel ballroom. All of them 'Vioxx lawyers' trying to figure out the best way to attack the 'Bank of Merck'.

Since the FDA recalled Vioxx, product liability lawfirms have been building lists of clients that had allegedly been harmed by Merck's pain killer medication. Meetings like the one held this week in Philadelphia allow the lawyers to discuss strategies, case law, the role of the FDA and the preparation of witnesses. With billions of dollars at stake - these are inportant meetings.

Many of the 'Vioxx lawyers' at this meeting believe they have strong cases against Merck. They can cite numerous studies that link Vioxx to increases in heart attack and stroke. They can also refer to a series of internal company communications that suggests Merck executives knew about Vioxx's dangers before the recall.

On the other side of this issue stands Merck. They insist that they want to try each of the cases separately and not as a class action. They believe that it will be hard to prove a direct link between taking Vioxx and suffering a heart attack. They say many of the Vioxx patients were older and therefore already at risk. Also, Merck executives say the internal communications have been taken out of context and that they have nothing to hide.

Vioxx Lawyers vs Corporate Giants

It's going to be an interesting battle. The 'Vioxx lawyers' against the huge corporation. With billions of dollars on the line, you have to think that somewhere John Grisham is watching very closely.

Editors note: John Grisham is the author of 'The King of Torts', which gives some unique insites into the legal profession the the system of class action lawsuits.

Related article:Can Vioxx Lawsuits be Won

More Evidence of Vioxx and Celebrex Dangers

2005-01-17T20:48:00.000-05:00

Two new articles published in this week's issue of the American Heart Association journal, 'Circulation', show more evidence that the COX-2 class of drugs, (Celebrex, Vioxx and Bextra) increase the risk of heart disease.

The first study shows that Pfizer Inc.'s Bextra can triple the risk of heart attack and stroke in certain patients.

Dr. Garret FitzGerald of the University of Pennsylvania School of Medicine and colleagues used a statistical approach called meta-analysis to combine the findings of two trials to estimate the risk of heart attack and stroke in people taking Bextra, another COX-2 inhibitor made by Pfizer.

Their analysis, first presented at a Heart Association meeting last November suggests Bextra tripled the combined incidence of heart attack and stroke in heart bypass surgery patients.

NSAIDS work by suppressing two enzymes called COX-1 and COX-2. But they can cause gastrointestinal bleeding, and research had suggested that suppressing COX-1 caused this damage.

So drug companies worked to make drugs that only affect COX-2, the enzyme associated with pain and inflammation.

But in the second study, the researchers studied mice genetically prone to hardening of the arteries or atherosclerosis and found that a compound called thromboxane or TxA2, produced by COX-1, accelerates atherosclerosis.

"This is of particular interest, as low-dose aspirin prevents heart attack and stroke by blocking COX-1 formation of TxA2 in blood cells called platelets," FitzGerald said in a statement.

When a COX-2 inhibitor was added, something happened that may help explain why the COX-2 inhibitors raise the risk of a heart attack, said FitzGerald's colleague, Karine Egan.

"Addition of the COX-2 inhibitor caused changes that, if they occurred in humans, would result in a loss of stability of the plaque, making it more likely to rupture and activate clotting, causing heart attack or stroke," she said.

"These results would have disturbing implications for patients at high cardiovascular risk treated with aspirin and a coxib (COX-2 inhibitor)," FitzGerald said.

If Pfizer needs any further reason to recall Celebrex and Bextra perhaps they should read Dr. FitzGerald's conclusions, "The clear emergence of a cardiovascular hazard from COX-2 inhibitors in patients, the weak rationale for a study of their protective properties in the first instance, and now this evidence from mice would indicate to me that a trial in high-risk patients, such as that proposed for Celebrex is, at best, ill advised."

Related story: Celebrex and Vioxx Drug Information

European Medicines Agency to Probe Vioxx and Celebrex

2005-01-16T13:12:00.000-05:00

In a move that parallels that of the FDA, The European Medicines Agency will probe into the safety of the COX-2 drugs Vioxx, Celebrex and Bextra. Officials from Pfizer Inc, Merck & Co Inc and Novartis AG will appear before a panel of European drug experts next week, (Novartis has a new COX-2 drug called Prexige which they have not sought approval for due to the Vioxx controversy).

The European drug agency's Committee for Medicinal Products for Human Use has the power to recommend withdrawal, suspension or extra warnings. The committee is now considering whether to revise its advice to EU countries on use of all COX-2 drugs but will not necessarily make any immediate recommendations after its Jan 17-20 meeting.

"We are calling the companies in to present data and answer questions," Martin Harvey, a spokesman for the London-based agency, said.

Vioxx has been pulled from the market and its maker Merck faces billions of dollars in class action claims. Celebrex and Bextra are still available but their maker, Pfizer Inc. has pulled all advertising. The FDA has announced that they will further investigate the COX-2 drugs February 16, 17 and 18, 2005 in Gaithersburg, Md.

FDA to Probe NSAIDs (Celebrex, Vioxx and Bextra)

2005-01-15T13:48:00.000-05:00

The FDA announced Friday that it will hold three days of hearings in February on the benefits and risks of the COX-2 family of drugs. This includes Pfizer Inc.'s Celebrex and Bextra arthritis medications.

Kathleen Quinn, a spokeswoman for the FDA, said regulators would allow the public to comment, either orally, in writing or with data. Public comments would be allowed during the first day of the hearing between 1 and 3 p.m., but time would be limited.

Pfizer (Celebrex and Betra) officials have been asked to make presentations during the three-day hearing and will participate. They say they welcome the opportunity to be heard but haven't determined which officials will be making presentations.

What follows is the press release from the FDA web site:

FDA Announces Dates for Public Meeting on Non-Steroidal Anti-Inflammatory Drugs

The Food and Drug Administration (FDA) has announced a joint public meeting of the agency's Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee to be held February 16, 17 and 18, 2005.

The committees will discuss the overall benefit-to-risk considerations (including cardiovascular and gastrointestinal concerns) for COX-2 selective non-steroidal anti-inflammatory drugs (NSAIDs) and related medicines.

Members of the public are encouraged to participate in this meeting. Interested persons may present data, information or views, orally or in writing, on issues pending before the committees. Oral presentations from the public will be scheduled between 1:00 p.m. and 3:00 p.m. on February 17. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should register to speak at the meeting before February 4, 2005. No registration is required for those only planning on attending the meeting.

The three-day meeting will be held at the Hilton Washington DC North, 620 Perry Parkway, Gaithersburg, Md. The proceedings will start at 8:00 a.m. each day. Agendas and other background materials will be posted online no later than one business day before the meeting.

For more information regarding this meeting, including contact information for members of the public interested in making presentations or submitting written comments please go to: http://www.fda.gov/oc/advisory/accalendar/2005/cder12532ddd0216171805.html.

####

Vioxx and Celebrex Victims About to Lose Rights?

2005-01-13T09:04:00.000-05:00

Over the years, two systems have emerged that act to protect the American consumer. The first is the various regulatory agencies that oversee the production and distribution of products. Among them are the Department of Labor, the Consumer Product Safety Commission and of course the Food and Drug Administration (FDA). Each of these organizations has various functions, but their principle job is to protect the American consumer from unsafe situations and products.

The second system that protects the consumer is the legal system and in particular, laws known as 'torts'. These laws allow the consumer to file suit against companies that have produced dangerous products or have acted fraudulently etc. If you have been harmed by a company or their products you have the right to sue that company.

When regulatory agencies fail to do a complete job and citizens are exposed to potentially dangerous products such as Celebrex, Vioxx and Bextra there has always been the option to use the tort laws and file suit. The tort laws provided a strong monetary incentive for companies to ensure that the products that they sold were safe for consumers to use.

Bush Wants to Change the Rules

It seems that this system is about to change. President Bush feels that agencies like the FDA are 'doing a spectacular job' and that the tort laws are too strong. He wants to change them to limit your ability to file suit and he wants to limit the amount of your settlement if you succeed in court. President Bush is seeking to limit the rights of people harmed by drugs like Vioxx.

Unforunately, as is so often the case with this president, he is out of step with reality. We are living in a world of instant gratification. Companies are pushing harder and harder to get products to market - often without ensuring that they are adequately tested. Competition is intense and the push to get new products to market is heightened by shareholders that want immediate results. So, does Bush do the logical thing and give agencies like the FDA more power and money to further protect American citizens? No. He seeks to limit their ability to file suit.

FDA Failed in Vioxx and Celebrex Cases

The simple truth here is that agencies like the FDA are no longer able to do their job properly. They are grossly underfunded and in many cases quite powerless. (The FDA can't even control pharmaceutical companies advertisiing direct to the public.) When regulatory agencies such as the FDA cannot do their job, the tort laws become the only defense against corporate negligence and greed.

With Bush in power and the Republicans having received millions from the pharmaceutical companies in re-election campaign funds, it's likely that things are about to change. Do you know someone that has been hurt by the use of Vioxx? Ask if they like the proposed changes.

For a related story: Bush Protects Makers of Vioxx and Celebrex

Celebrex Class Action Lawsuit filed in Pittsburgh

2005-01-12T13:23:00.000-05:00

The Law Office of Alfred G. Yates Jr., PC has announced that a class action lawsuit was filed against Pfizer Inc. in the United States District Court for the Southern District of New York.

The suit was filed on behalf of all purchasers of the common stock of Pfizer, Inc. between November 1, 2000 and December 16, 2004 and alleges that Pfizer issued "false and misleading statements and omissions concerning the safety and marketability of Pfizer's Celebrex and Bextra products."

The suit further alleges that the defendants "knew or recklessly disregarded that the undisclosed health risks posed by these drugs would limit their marketability, and that potential financial liability Pfizer faced from the harms these drugs caused posed a serious threat to the Company's financial condition."

For more information on this lawsuit contact the Law Office of Alfred G. Yates Jr., PC, 800-391-5164 E-mail: yateslaw@aol.com

Related article: Celebrex Lawsuits

Vioxx and Celebrex Lawsuit Conspiracy?

2005-01-11T11:38:00.000-05:00

Is it fair to say that President Bush and the makers of Vioxx (Merck) and the maker of Celebrex (Pfizer Inc.) have entered into a conspiracy to limit the liability of pharmaceutical companies and therefore infringe on the rights of American citizens? You be the judge . . .

In late September of 2004 the FDA ordered the recall of Vioxx after studies showed that it increased the risk of serious heart problems. This was followed by an avalanche of Vioxx class action lawsuits, filed on behalf of those that had been injured or killed by Vioxx use.

Shortly thereafter, another study showed that two other COX-2 type drugs, Celebrex and Bextra also caused similar heart problems. The drugs, Celebrex and Bextra were not recalled but all advertising for them was halted.

About this time President Bush arrived on the scene and began promoting a piece of legislation that would sharply limit the liability of the drug manufacturers. In fact it would cap damage awards at just $250,000. Bush was quoted as saying,

"...What's happening all across this country is that lawyers are filing baseless suits...That means you're paying for junk lawsuits every time you go to see your doctor...", but Bush's own Congressional Budget Office estimated that malpractice costs are approximately 2% of health care costs while pharmaceutical cost are between 12 and 16%.

"If President Bush wants to create more affordable and accessible health care, he should allow Americans to buy their prescription drugs through bulk purchasing programs as Canadians do and he will reduce health care costs by up to 10%," said Jamie Court, president of the Foundation for Taxpayer and Consumer Rights. "The President should not be scaring the public into falsely believing they must give up their right to go court out of fear of losing their ability to go to an emergency room."

Joan Claybrook, President of Public Citizen had this to say,
"President Bush doesn't let facts get in the way when it comes to his political goal of dismantling the legal system. He prefers to coddle campaign contributors, rather than protect consumers and patients."

Frank Clemente, director of Public Citizen's Congress Watch added,
"This is not a debate among reasonable people. It is a massive campaign of distortions carried out by the administration in league with its business allies. The fact is, the emperor has no clothes."

So, here are the facts. The drug companies don't want to have to pay damages when faced with class action lawsuits concerning drugs like Vioxx, Celebrex and Bextra. President Bush is on the side of the drug companies. He wants to limit your right to file suit and he wants to limit your award should you happen to win. Just one more fact . . . . the drug companies donated millions of dollars to the Bush re-election campaign.

For a related story: Vioxx Lawsuits

Selecting a Vioxx or Celebrex Attorney

2005-01-09T13:27:00.000-05:00

*Editors Note* This article has been written specifically for those interested in information about Vioxx lawsuits but may become applicable to the users of Celebrex and as such, has been added here.

Since the painkiller Vioxx was recalled by Merck in late September, hundreds of lawsuits have been filed on behalf of thousands of Vioxx users. Did you use Vioxx? Were you damaged in any way from using Vioxx? Do you have a case against Merck? Consulting a class action attorney is the only way to know.

The following information relates to the Vioxx recall and the selection of a Vioxx attorney but it may also apply in the case of a Celebrex or Bextra recall.

Finding a Vioxx Attorney

1) Consult a Vioxx attorney. Not all attorneys specialize in class action suits, so just any attorney will not do. Look at the ads on this page or do a 'Google' search for "Vioxx attorney".

2) If you visit a website and you don't see clearly that it is operated by a lawyer - leave. Do not give any personal information to an intermediary of any kind. A website operated by a Vioxx attorney should have complete contact information including the name, address and phone number and not just an email address.

3) If something looks 'too good to be true' - it probably is 'too good to be true'. Don't be fooled by phony websites that promise to make you a 'Vioxx millionaire'.

4) Consult with friends and relatives regarding the selection of a Vioxx attorney. They may know of an excellent attorney that specializes in class action lawsuits.

5) Be informed. Read articles on Vioxx recall and Vioxx lawsuits on this site and on sites such as Vioxx News and Celebrex and Vioxx Update.

6) The only person that can tell if you have a viable case is a Vioxx attorney. If you or someone you love has been hurt by the use of Vioxx, you owe it to yourself to consult with a Vioxx attorney.

Doctors Not Prescribing Celebrex and Bextra

2005-01-07T11:12:00.000-05:00

After the recall of Vioxx, sales of competitor, Celebrex climbed sharply as doctors and patients looked for an alternative. However, that Celebrex sales increase was short lived due to the release of test results that showed Celebrex caused heart complications similar to Vioxx. Now many doctors and patients are again seeking an alternative pain killer.

Patients are clearly concerned for their health. On one hand they seek relief from the pain and on the other hand they must be concerned about heart complications that may be caused from taking COX-2 drugs such as Celebrex and Bextra.

"Celebrex Risk Too Great"

Doctors are also concerned about their patients' health and also must be aware of liability risks associated with prescribing these COX-2 class drugs.

Commenting on the Celebrex situation, Dr. Michael Halperin, a surgeon with the Norwich Orthopedic Group said, “I'm not saying Celebrex should never be prescribed, But legally, for me, it's a risk I don't need to take, especially when there are plenty of other medications out there that are equally effective.”

Due to the lack of definitive information from Pfizer Inc. and the FDA many doctors are taking a conservative approach and as a result some analysts are predicting that sales of Celebrex and Bextra will drop by as much as fifty percent.

Related article: Celebrex Side Effects

Can Vioxx Lawsuits be Won?

2005-01-06T11:25:00.000-05:00

Lawyers throughout the country have been collecting Vioxx clients at a rapid pace and have increased their advertising dramatically. Many Vioxx users have suffered serious heart problems and are looking for a legal remedy.

Vioxx Cases aren't 'Open and Shut'

Even though many feel that these are 'open and shut' type cases, it won't be that easy! Merck executives have already stated that they will defend every case and to be fair, Merck withdrew Vioxx as soon as it learned of the adverse side effects. The majority of those taking Vioxx suffered from arthritis or other joint related problems and tended to be older. This same group of people are statistically more susceptible to stroke and heart attack, so proving that a heart problem was solely caused by Vioxx could be difficult.

Further complicating the picture is the fact that Merck has just $630 Million in product liability for Vioxx claims. It is therefore a possibility that some claimants will find that the 'well has run dry'.

Also posing a potential problem is the proposed bill, supported by President Bush, that would severely limit the pharmaceutical companies' liability in class action suits if the drug in question had met all FDA requirements.

Vioxx Lawyers in Advertising Frenzy!

2005-01-06T11:21:00.000-05:00

Trial lawyers throughout the U.S. have become increasingly aggressive in their attempts to attract Vioxx clients. With an estimated 20 million Vioxx users, the number of potential clients is far greater than any other class action lawsuit.

The number of potential clients combined with the huge possible financial windfall has caused lawyers everywhere to increase their advertising expenditures. This is most evident on the internet where law firms are building web sites and buying ads at a rapid pace. Lawyers are finding that the most cost effective way to reach potential clients is on the net. The cause of all this activity - Vioxx class action suits.

Bush Legislation Protects Drug Companies

2005-01-05T13:32:00.000-05:00

A medical malpractice bill that has passed the house but not the Senate has the support of President Bush. Bush has often praised the bill because it would stop the many frivolous lawsuits filed against doctors every year. What he doesn't often speak about are the provisions in the bill that would protect pharmaceutical companies.

Merck, the makers of Vioxx and Pfizer Inc. the maker of Celebrex would appear to be the two largest beneficiaries of this legislation. Vioxx was pulled from the market this past September and hundreds of Vioxx lawsuits have already been filed. Pfizer Inc. has not recalled Celebrex but has suspended all advertising. Several Celebrex lawsuits have been filed including one in Canada and one in Illinois.

Vioxx and Celebrex Lawsuits in Jeopardy

It is believed that both Merck and Pfizer would be shielded from punitive damages if this legislation becomes law. In fact, all pharmaceutical comapanies would be protected as long as they had met all FDA standards.

The exact extent of the protection allowed is not known however the position of the Association of Trial Lawyers of America is perfectly clear. Their president, Todd A. Smith said,

"President Bush unashamedly advocates legislation that would protect insurance industry profits and prohibit any punishment for the makers of dangerous drugs like Vioxx."

For more information see Vioxx Lawsuits

Celebrex Lawsuit Filed by Investors Against Pfizer

2005-01-04T20:00:00.000-05:00

An article on www.nylawyer.com says that the makers of Celebrex, Pfizer Inc. have been sued by investors in the company. The suit was filed in Hartford, Conn. by the law firm of Scott & Scott.

The lawsuit alleges that false statements made by the company with regard to the safety of Celebrex kept the share price artificially high. Investors were then hit hard when results of other studies showed a risk of heart attack from using Celebrex. At this time Pfizer Inc. shares dropped by $3.23 which erased approximately $25 billion of the company's market value.

This is believed to be the first lawsuit of this type related to the drug Celebrex. A large class action suit has been filed by a Canadian lawfirm and another class action suit has been filed in Illinois.

Vioxx Related Deaths and Injuries Estimated at up to 139,000

2005-01-04T19:58:00.000-05:00

The FDA scientist in the middle of the Vioxx controversy has stated in an interview with Andrew Jack of the Financial Times that he intends to publish research that idicates up to 139,000 people have been injured or killed by Vioxx.

Dr. David Graham had originally estimated that 28,000 people had been seriously affected by Vioxx and has since revised these estimates.

"In an interview with the FT, Dr Graham said he was determined to go ahead with publication of his updated analysis, even though he had been threatened with dismissal by the FDA if he wrote and published the paper."

"The FDA has suppressed the paper and maligned me in the media but never responded. The proper place for scientific information is in a peer-reviewed scientific journal," he said.

For the complete story: Vioxx Side Effects
Also see Doctors Need Drug Data

Celebrex, Vioxx Lawsuits Top Medical Stories for 2004

2005-01-04T19:56:00.000-05:00

COX-2 inhibitors, painkillers Vioxx and Celebrex came under fire in 2004. Vioxx was recalled from the market amid claims that its continued use would result in heart complications. Hundreds of Vioxx lawsuits have been filed as a result. Merck, the makers of Vioxx have stated that they will defend against all Vioxx class action lawsuits.

Celebrex, another of the COX-2 type drugs has also (along with Bextra) been identified as causing the same type of heart problems as Vioxx. The makers of Celebrex, Pfizer Inc. has suspended all Celebrex advertising, but has not recalled the product. Pfizer executives site the many years of safe use of Celebrex and insist that using Celebrex is not unsafe. Like Merck (makers of Vioxx) Pfizer executives have stated that they will fight any Celebrex related lawsuits.

2004 has ended with many pain sufferers looking for alternatives to Vioxx and Celebrex. Questions are being asked about the effectiveness of the FDA and it's handling of the Vioxx, Celebrex and Bextra situations. Hundreds of Vioxx lawsuits and at this writing, at least two Celebrex class action lawsuits have been filed - but above all else, people want answers.

What will 2005 bring? It's anyones guess, but the Vioxx and Celebrex stories aren't over yet.

For more information: FDA Advisory: Vioxx, Celebrex & Bextra

Merck President to Testify at Vioxx Lawsuits

2005-01-04T19:54:00.000-05:00

According to an AP article by Linda A. Johnson in the Miami Herald, State Superior Court Judge Carol E. Higbee has issued a verbal order which will require Raymond V. Gilmartin "to answer questions from plaintiffs' attorneys about his knowledge of risks associated with Vioxx before Merck voluntarily pulled it from the market worldwide on Sept. 30."

Attorneys for plaintiffs in the many Vioxx cases filed so far against Merck clearly want to know exactly what the top executives knew about the dangers of Vioxx before the recall.

For the complete story: Merck CEO to Testify on Vioxx

Celebrex Class Action Lawsuit Filed in Illinois

2005-01-04T19:50:00.001-05:00

An article written by Brian Brueggemann (bbrueggemann@bnd.com)for the Belleville News Democrat, states that the first in what is believed to be a flood of class action lawsuits against Pfizer Inc. has been filed in Illinois.

There is only one plaintiff in the case so far but attorneys are asking the court to certify the case as a class action.

The suit alleges: "Pfizer negligently marketed Celebrex despite the fact that the risk and the effect thereof on the body were so unreasonably high and severe that no reasonable pharmaceutical company, exercising due care, would have done so."

For the entire story: Celebrex Lawsuit Filed
For more information see: German Celebrex Lawsuits and Canadian Celebrex Lawsuits

Doctors Need Drug Data

2005-01-04T19:50:00.000-05:00

In an article for the New York Times News Service, writer Barry Meier reports that doctors are having a difficult time assessing pain relievers with the recent Vioxx recall and the problems now associated with Celebrex, Bextra and Aleve.

"We are desperately in need of information," said Dr. Stephen Brenner, an internist in New Haven, Conn.

However, it seeems that for some, the information has been available. The Mayo Clinic, the federal Veterans Affairs Department and the Kaiser Permanente Health Plan all did reviews of available test data and as a result limited the use of Vioxx, Celebrex and Bextra. Reviews like this are called evidence-based reviews and are used to determine the real benefits and drawbacks of various drugs.

So, why aren't these reviews made available to all doctors . . .?

For the entire story: Celebrex, Bextra, Vioxx Information

Cardiologists Call for More COX-2 Testing

2005-01-04T19:49:00.000-05:00

In an article posted Tuesday on the Journal of the American Medical Association's website, Eric Topol, chief cardiologist at the Cleveland Clinic Foundation, states that health risks found in drugs such as Celebrex, Vioxx and Bextra underscore the need for health authorities to test drugs already on the market.

Vioxx, Bextra and Celebrex are the only Cox-2 inhibitors authorized by the FDA since the 1990s and "Had coxib trials been conducted five years ago in patients with established cardiovascular disease, when the benefit and risks were indeterminate, clinicians would have quickly learned the risk and potentially avoided a major cardiovascular calamity," wrote Topol.

For the rest of the story: Celebrex Side Effects

UAB Halts Celebrex Testing Research

2005-01-04T19:48:00.000-05:00

Officials at the University of Alabama (Birmingham) have stopped all testing related to the drug Celebrex as a result of Celebrex maker Pfizer Inc. announcing it had found an increased risk of heart attacks among people taking large doses of the drug.

The UAB is a major medical research center. Due to the safety questions surrounding Celebrex at this time, researchers have called all Celebrex study participants and told them to stop taking the drug.

For the entire story: Celebrex Risks

Story on WPMI News - www.wpmi.com

FDA Advisory - Vioxx, Celebrex and Bextra

2005-01-04T19:46:00.000-05:00

On December 23rd the FDA issued the following Public Health Advisory with regard to the COX-2 group of drugs that include Vioxx, Celebrex and Bextra

FDA Issues Public Health Advisory Recommending Limited Use of Cox-2 Inhibitors
Agency Requires Evaluation of Prevention Studies Involving Cox-2 Selective Agents

The Food and Drug Administration (FDA) today issued a Public Health Advisory summarizing the agency's recent recommendations concerning the use of non-steroidal anti-inflammatory drug products (NSAIDs), including those known as COX-2 selective agents. The public health advisory is an interim measure, pending further review of data that continue to be collected.

In addition, FDA today announced that it is requiring evaluation of all prevention studies that involve the Cox-2 selective agents Celebrex (celecoxib) and Bextra (valdecoxib) to ensure that adequate precautions are implemented in the studies and that local Institutional Review Boards reevaluate them in light of the new evidence that these drugs may increase the risk of heart attack and stroke. A prevention trial is one in which healthy people are given medicine to prevent a disease or condition (such as colon polyps or Alzheimer's disease).

FDA is issuing an advisory because of recently released data from controlled clinical trials showing that the COX-2 selective agents (Vioxx, Celebrex, and Bextra) may be associated with an increased risk of serious cardiovascular events (heart attack and stroke) especially when they are used for long periods of time or in very high risk settings (immediately after heart surgery).

Also, as FDA announced earlier this week, preliminary results from a long-term clinical trial (up to three years) suggest that long-term use of a non-selective NSAID, naproxen (sold as Aleve, Naprosyn and other trade name and generic products), may be associated with an increased cardiovascular (CV) risk compared to placebo.

Although the results of these studies are preliminary and conflict with other data from studies of the same drugs, FDA is making the following interim recommendations:

* Physicians prescribing Celebrex (celecoxib) or Bextra (valdecoxib), should consider this emerging information when weighing the benefits against risks for individual patients. Patients who are at a high risk of gastrointestinal (GI) bleeding, have a history of intolerance to non-selective NSAIDs, or are not doing well on non-selective NSAIDs may be appropriate candidates for Cox-2 selective agents.
* Individual patient risk for cardiovascular events and other risks commonly associated with NSAIDs should be taken into account for each prescribing situation.
* Consumers are advised that all over-the-counter (OTC) pain medications, including NSAIDs, should be used in strict accordance with the label directions. If use of an (OTC) NSAID is needed for longer than ten days, a physician should be consulted.

Non-selective NSAIDs are widely used in both over-the-counter (OTC) and prescription settings. As prescription drugs, many are approved for short-term use in the treatment of pain and primary dysmenorrhea (menstrual discomfort), and for longer-term use to treat the signs and symptoms of osteoarthritis and rheumatoid arthritis. FDA has previously posted extensive NSAID medication information at http://www.fda.gov/cder/drug/analgesics/default.htm.

FDA is collecting and will be analyzing all available information from the most recent studies of Vioxx, Celebrex, Bextra, and naproxen, and other data for COX-2 selective and nonselective NSAID products to determine whether additional regulatory action is needed. An advisory committee meeting is planned for February 2005, which will provide for a full public discussion of these issues.

Doctor Finds Problems with Celebrex

2005-01-04T19:44:00.000-05:00

In an article for Health Team 9, writer Elizabeth Cohen reports that Dr. Garrett Fitzgerald noticed problems with Celebrex more than five years ago.

It seems that Celebrex is effective, at least in part because it inhibits the production of a certain type of fat that is necessary for the protection of the heart. "When you shut down the fat you're exposing the cardiovascular system to danger, so it's really a double edged sword," Fitzgerald said.

Dr. Fitzgerald published his findings but received mixed reviews at best - especially from the phamaceutical companies like Pfizer (makers of Celebrex) who chose to rely on other studies that contradicted his results.

For the complete story: Celebrex Problems

FDA Issues Public Health Advisory

2005-01-04T19:40:00.000-05:00

Public Health Advisory
Vioxx and other Non-Steroidal Anti-Inflammatory Drug Products (NSAIDS)

The FDA is issuing a public health advisory concerning use of non-steroidal anti-inflammatory drug products (NSAIDS) including those known as COX-2 selective agents.

Recently released data from controlled clinical trials showing that the COX-2 selective agents (Vioxx, Celebrex, and Bextra) may be associated with an increased risk of serious cardiovascular events (heart attack and stroke) especially when they are used for long periods of time or in very high risk settings (immediately after heart surgery).

Preliminary results from a long-term clinical trial (up to three years) suggest that long term use of a non-selective NSAID, naproxen (sold as Aleve, Naprosyn and other trade name and generic products), may be associated with an increased cardiovascular (CV) risk compared to placebo.

While the results of these studies are preliminary and conflict with other study data on the same drugs, FDA is providing this advisory as an interim measure, pending further review of data that continue to be collected. Specifically:

* Physicians prescribing Celebrex (celecoxib) or Bextra (valdecoxib), should consider this emerging information when weighing the benefits against risks for individual patients. Patients who are at a high risk of gastrointestinal (GI) bleeding, have a history of intolerance to non-selective NSAIDs, or are not doing well on non-selective NSAIDs may be appropriate candidates for COX-2 selective agents.
* Individual patient risk for cardiovascular events and other risks commonly associated with NSAIDs should be taken into account for each prescribing situation.
* Consumers are advised that all over-the-counter (OTC) pain medications, including NSAIDs, should be used in strict accordance with the label directions. If use of an OTC NSAID is needed for longer than ten days, a physician should be consulted.

Non-selective NSAIDs are widely used in both over-the-counter (OTC) and prescription settings. As prescription drugs, many are approved for short-term use in the treatment of pain and primary dysmenorrhea (menstrual discomfort), and for longer-term use to treat the signs and symptoms of osteoarthritis and rheumatoid arthritis. FDA has previously posted extensive NSAID medication information at http://www.fda.gov/cder/drug/analgesics/default.htm.

FDA will be analyzing all available information from the new studies of Vioxx, Celebrex, Bextra, and naproxen, and other data for non-selective NSAIDs and COX-2 selective products to determine whether additional regulatory action is needed. An advisory committee meeting is planned for February 2005 which will provide for a full discussion of these issues.

For more Information: Vioxx, Bextra, Celebrex Information

Canadian Lawyers Launch Celebrex Lawsuit

2005-01-04T19:38:00.000-05:00

According to a CTV Television News report, "A Toronto law firm has launched a $1.5 billion class-action lawsuit against Pfizer on behalf of all Canadians who took Celebrex."

The statement of claim reads in part, "The plaintiff submits that the defendants were negligent in the design, testing, advertising, marketing, promoting, labeling, warnings given and sale of Celebrex".

The lawsuit also claims that Pfizer (the makers of Celebrex) should have known the drug would cause physical harm.

For the entire story: Celebrex Lawsuits

Celebrex, Bextra and Vioxx Side Effects on Health Canada

2005-01-04T19:32:00.001-05:00

The following press release has been posted on the Health Canada website regarding safety considerations and side effects of Vioxx, Celebrex, Bextra and Mobicox.

OTTAWA p of drugs known as selective COX-2 inhibitor NSAIDs (non-steroidal anti-inflammatories). These include Vioxx (rofecoxib), which has been withdrawn from the market, Celebrex (celecoxib), Bextra (valdecoxib), and Mobicox (meloxicam), which are used in the treatment of symptoms of rheumatoid arthritis, osteoarthritis and primary dysmenorrhea (menstrual pain).

Accumulating evidence indicates that the use of selective COX-2 inhibitor NSAIDs, in certain individuals, is associated with an increased risk of heart attack or stroke whe-Health Canada wishes to inform Canadians of safety concerns regarding the groun compared to placebo. The risk appears to increase with the total daily dose and the length of the treatment. However, given the available data, it is not possible to identify which patients would present a higher risk of heart attack and stroke.

Health Canada has requested additional safety information from the manufacturers of Celebrex®, BextraTM, Mobicox® and generic forms of meloxicam, and will continue to review the safety profile of these drugs in order to fully consider what is presently known about the risks and benefits of these drugs when used according to their labelling.

Until further information from long-term clinical trials becomes available, one should consider that there is a strong possibility of an increased risk of cardiovascular events, including heart attack and stroke, when using selective COX-2 inhibitor NSAIDs (Celebrex®, BextraTM, Mobicox®, and all generic forms of meloxicam).

Patients should discuss the benefits and risks of treatment options with their physician, in light of the following information.

Vioxx® (rofecoxib)
Vioxx® was withdrawn on September 30, 2004, based on new safety information from a three-year, randomized double-blind clinical trial, called APPROVe, showing a possible increased risk of cardiovascular events. The APPROVe (Adenomatous Polyp Prevention on VIOXX) clinical trial was designed to assess the effectiveness of 25 mg Vioxx® in preventing the recurrence of colon polyps (abnormal tissue growth, which may or may not be cancerous). In the APPROVe trial, Vioxx® was compared to a placebo (sugar pill). Merck & Co withdrew Vioxx from the worldwide market after the study indicated an increased risk of serious cardiovascular events, such as heart attacks and strokes, after 18 months of continuous treatment.

BextraTM (valdecoxib)
On December 10, 2004, Pfizer Inc. released new information about cardiovascular risks associated with BextraTM. In a study conducted by Pfizer, which included over 1,500 patients treated for acute pain after coronary artery bypass grafting (CABG), an increased risk of cardiovascular events was observed in patients treated with BextraTM compared to placebo. These cardiovascular events included myocardial infarction (heart attack), cerebrovascular accident (stroke), deep vein thrombosis (blood clots in the leg), and pulmonary embolism (blood clot in the lung). The risk of these effects was observed to be greater with the intravenous form of the drug (approximately two percent of patients had such an adverse event), in comparison with the oral form of the drug (approximately 1 percent of patients), immediately following CABG surgery. About 0.5 percent of patients taking the placebo had an adverse cardiovascular event.

Celebrex® (celecoxib)
On December 17, 2004, the National Cancer Institute (NCI) in the United States announced that it had stopped a three-year Celebrex® study called Adenoma Prevention with Celecoxib (APC) due to an interim analysis showing a statistically significant increase in the risk of heart attack, stroke and cardiovascular death. Health Canada has withdrawn market authorization for the use of Celebrex® for the prevention of recurrence of Familial Adenomatous Polyposis, which is predictive of colorectal cancer. Celebrex® should not be taken for the prevention of recurrence of Familial Adenomatous Polyposis and patients should discuss alternative therapeutic options with their doctors.

Flood of Celebrex Lawsuits?

2005-01-04T19:32:00.000-05:00

With recent clinical trial information released and a halt to Celebrex advertising can a flood of Celebrex lawsuits be far behind? In a New York Times article entitled 'The Fallout From Celebrex', writer Barnaby J. Feder asks that question.

Most attorneys do not feel that the case against Pfizer will be as strong as the one against Merck. (re. Vioxx lawsuits) There have been not major clinical studies suggesting that Celebrex poses as great a risk as Vioxx. Also, no documents have emerged thus far suggesting that Pfizer knew of any other potential problems with Celebrex.

Estimates on the number of Celebrex lawsuits filed vary. Pfizer admits to 24 Celebrex lawsuits filed at this time.

For the entire story: Celebrex Lawsuits

Celebrex Safety

2005-01-04T19:29:00.001-05:00

The executives at Pfizer's head offices will be breathing a little easier today with the results of a recent Alzheimer's Disease prevention study.

As reported at medicalnewstoday.com, "The National Institutes of Health has reported in an Alzheimer's Disease prevention study that there was no increased cardiovascular risk seen in elderly patients taking Celebrex (400 mg daily) for up to three years. These results are consistent with the large body of Celebrex scientific evidence that has accumulated over 10 years in more than 40,000 patients."

The emergence of well documented studies such as this make launching a successful Celebrex lawsuit very difficult. However, in other news, the same study reported "an increased cardiovascular risk among patients taking Aleve (naproxen), an over-the-counter pain reliever."

For the complete story: Celebrex Safety

Also see: Celebrex Information

Vioxx Refunds Made Easier

2005-01-04T19:29:00.000-05:00

Merck & Co. agreed Monday to simplify the Vioxx refund process, according to Attorney General Jim Petro. Merck made this decision following negotiations with Petro and the attorneys general of seven other states.

Merck will no longer require that Vioxx users send in their unused drugs before receiving a refund and will also pay shipping costs for customers sending in their unused Vioxx. The deadline to apply for a refund has been extended through March.

Consumers needing information about the Vioxx recall should contact the Merck Refund Center at 800-805-9542.

Click here for more Vioxx Recall Information

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