Posted on 10/16/2004 9:44:53 AM PDT by neverdem
Pfizer warned doctors yesterday that one of its best-selling painkillers, Bextra, might increase the risk of heart attack or stroke in coronary artery bypass surgery patients. The announcement comes just two weeks after Merck removed from the market its painkiller, Vioxx, which is in the same class of medicines as Bextra, because a study showed that the risk of heart attacks doubled for patients who had taken Vioxx 18 months or longer.
Pfizer said a clinical study involving more than 1,500 patients showed that those who had undergone bypass surgery and had taken Bextra intravenously and orally were at higher risk for heart attacks. An initial study last year raised similar concerns in the same kinds of patients.
The painkillers known as COX-2 inhibitors, which include Bextra and Vioxx, have been widely prescribed to people with arthritis. Merck's decision to withdraw Vioxx cast suspicion on the safety of drugs in that class. Now Pfizer's warning is sure to fuel the debate about the overall safety of these drugs for all patients.
Officials of the Food and Drug Administration said yesterday that the agency would convene a panel of independent experts in January to discuss these issues. Regulators abroad have also indicated plans to review COX-2 drugs.
Pfizer said it was already conducting research into whether Bextra increases the risk of heart attacks in people taking the drug for chronic pain. The company also issued a warning yesterday about an extremely rare and potentially fatal skin reaction to Bextra.
In addition to Bextra, Pfizer also makes Celebrex, the best-selling COX-2 drug on the market. Bextra is the company's new and faster-acting version of Celebrex.
Pfizer says there is no evidence that its drugs have problems similar to Vioxx because they are chemically different. Although Bextra is not approved for use for surgery patients, Pfizer said its studies had shown that general surgery patients - as opposed to bypass patients - are not at higher risk for heart attacks.
But some doctors say this group of drugs may work in a way that increases the risk of heart problems for some patients, and they point to this latest information as additional reason for concern.
"There are serious questions to be addressed here," said Dr. Garret A. FitzGerald, a University of Pennsylvania cardiologist and pharmacologist who raised concerns about the painkillers in The New England Journal of Medicine this month.
But Dr. FitzGerald also emphasized that these drugs are useful for certain patients. "We absolutely shouldn't yank these drugs as a class," he said.
Other doctors also expressed concerns about the new information from Pfizer. "It's going to require a lot of really serious looks," said Dr. David Campen, a rheumatologist for Kaiser Permanente in California, a major health network, who has also been involved in research on some of these drugs.
Millions of people have taken these drugs for pain and chronic conditions like rheumatoid arthritis, and sales of these three drugs - Vioxx, Celebrex and Bextra - exceeded $6 billion last year.
Regulators in Europe are expected to make a decision as soon as next week about whether to take any action on the drugs. The F.D.A.'s expert panel will review whether Celebrex and Bextra are safe, Dr. Sandra Kweder, acting director of the administration's office of new drugs, said in an interview yesterday.
While no study of either drug analyzed by the agency so far has been cause for concern, Dr. Kweder said, the agency is not sure it has all the information it needs. The agency is aware of the two studies involving the intravenous form of Bextra, but "it's unclear what the relationship is with the oral form," she said.
Other recent studies suggesting that all COX-2 inhibitors may have safety problems are still being analyzed by the agency, she said. Uncertainty over the safety of drugs is not uncommon, Dr. Kweder said, and that is "something we have to take into account with regard to every decision we make about marketing a new drug and every decision we make about withdrawal of a drug."
But some doctors say because the benefits of COX-2 drugs are so unclear, the advantages of taking one of these painkillers may not outweigh these risks.
"You have to treat people who are high risk conservatively," Dr. Campen said.
The F.D.A. will take this into account, Dr. Kweder said. She also noted that neither Celebrex nor Bextra had been proved to be any better than older medicines like ibuprofen at guarding against stomach bleeding, a benefit often cited with these drugs, and neither had been proved to be any better at relieving pain than older drugs.
The agency will have to balance the risks and benefits of these drugs. "That's what we're going to ask the advisory committee to do," she said.
Since the Vioxx withdrawal, Pfizer has been emphatic in distancing its drugs from Vioxx and playing down concerns about higher risk for heart attack and stroke. The company says it is even conducting research into whether Celebrex might reduce the risk of such events.
Many doctors have said it is critical that research be conducted to settle this issue. "It's a trial long overdue," said Dr. Eric J. Topol, chairman of cardiovascular medicine at the department at the Cleveland Clinic, who said the information about what happened in bypass patients was "very worrisome."
Dr. FitzGerald criticized Pfizer for not making this latest information public more quickly since the company had completed the study in the spring. Pfizer said it could not have released this information earlier because it had to analyze the information.
"I thought we took a rather extraordinary step," said Dr. Mitch Gandelman, a Pfizer executive, who said the company released the information before it normally would to quickly share it with doctors.Pfizer officials emphasized that the news about Bextra does not implicate Celebrex.
Shares of Pfizer's fell 58 cents, to close at $28.50 yesterday, although the shares had been down even more sharply earlier in the day.
Gardiner Harris contributed reporting for this article.
Last year my podiatrist prescribed Bextra for my plantar fasciitus. I went home and checked it out on WebMD and all kinds of WARNING signs came up. I refused to take it and am glad I didn't. My Dr. was not happy. In fact she thought I was crazy not to at least try it. Fortunately, I don't like taking pills of any kind or at least check them out first!
I got Bextra for my defective spinal problem. Had taken Vioxx for years.
Pfizer, who makes Bextra and Celebrex, is the company that martkets the RU-486 abortion pill in the US.
Will not take it any more. I'd rather be in pain than support Pfizer while it kills babies.
" I refused to take it and am glad I didn't"
That can be a catch22 situation. I've been prescribed several drugs that really reacted badly for me. I refused to continue taking them. Finally after years of misery and incapcitation from car wrecks, etc. I applied for disability. Because I refused to take the poison, I was declined benefits for "refusing treatment". I hope your condition doesn't disable you.
FReepmail me if you want on or off my health and science ping list.
Ditto with most prescription allergy medicines, since as Zyrtec, Allegra, etc. Benadryl off the shelf tends to work far better; the prescription meds' main benefit is that they're much less likely to make you drowsy.
I believe there were at least a couple of fairly large studies that showed there was a statistically significant decrease in the incidence of major gastro-intestinal(GI) bleeding compared to the older, over the counter(OTC), non-steroidal anti-inflammatory drugs(NSAIDs). IIRC, the decrease was about 4 or 5 percent, about 25% of folks taking older NSAIDs on a chronic basis had major GI bleeds, i.e. considered life threatening, compared to about 20% on a COX-2 inhibitor.
Ditto with most prescription allergy medicines, since as Zyrtec, Allegra, etc. Benadryl off the shelf tends to work far better; the prescription meds' main benefit is that they're much less likely to make you drowsy.
You're right on the money!
(hmm, now where'd I put that needle? Oh there it -- OUCH!)
kidding
Folks - THINK ABOUT IT. What course of treatment does not carry a risk?
These warnings are pre-emptive strikes in the on slught of law suits that TRAIL LAWYERS bring against every company who sells any type of drug, be it OTC or perscription. Their losess are mitigated when the user is warned about possible side effects - WHICH EVERY COURSE OF TREATMENT HAS.
So IF YOU really think there are BAD drugs, my suggestion to you is to TAKE NO DRUGS and live with the consequences of that decision. Of course, then you will have no one to sue but yourself.
Think about it.
My husband takes Bextra and it helps him so much. In fact, he is miserable without it.
Here's the Bextra info from the NYT.
Thanks, Dr. Eckleburg, for pinging me on this! I take Bextra, and I was concerned when I heard rumors about Bextra. I've taken it for over a year, and it's helped my stiffness from arthritis.
After reading the article, I've decided to wait for further research to be published, before I quit taking Bextra. My doctor continues to prescribe it for me, and I'll bring up this issue on my next visit.
bump and thanks!
Bextraa relieved and eliminated my costochronditis. 6 months of agony was eliminated by 2 months of Bextraa. When the discomfort went away, I ended the Bextraa.
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