Posted on 02/18/2005 6:04:57 AM PST by Cagey
WASHINGTON (AP) - The painkiller Vioxx, pulled from the market last fall because of reported heart problems and strokes in users, could come back on sale if federal regulators conclude it and similar drugs have benefits that balance the risks.
Dr. Peter S. Kim, president of Merck Research Laboratories, told a joint meeting of two Food and Drug Administration advisory committees on Thursday that new studies indicate the side effects aren't unique to its product.
The advisory panels were concluding a three-day meeting Friday in which they have been assessing drugs known as Cox-2 inhibitors, which also include Pfizer Inc. (PFE)'s Celebrex and Bextra, to determine whether they are all risky and, if so, whether they have balancing benefits.
All three drugs have been approved for sale by the government. The committees' recommendations could be the first steps toward rescinding those approvals.
Meeting chairman Alistair J.J. Wood of Vanderbilt University Medical School asked whether the drugs could win approval today, considering the studies that have come to light in recent months.
Kim indicated a positive assessment by the committees might lead Merck to consider bringing Vioxx back onto the market.
If the committees and the FDA conclude that the benefits of this class of drugs outweigh the risks for some patients, "then we would have to consider the implications of these new data" for Vioxx, Kim said.
Asked if he meant the company would consider returning Vioxx to the market, Kim said: "There are unique benefits to Vioxx. The science has progressed and we need to take that science into consideration."
While the committees heard evidence that all drugs in the group can increase the risk of heart attacks, irregular heart beat and strokes, it did note that Vioxx seemed to have more such reports than the other drugs.
(AP) Dr. Ned Braunstein, M.D., senior director of Merck Research Laboratories, gives a presentation... Full Image
On the other hand, Kim pointed out that Vioxx is the only one of the drugs approved for people with certain allergies and did better at preventing the stomach and intestinal problems often caused by over-the-counter painkillers.
Committee members will be asked their opinion on whether all the drugs pose a problem and what should be done. Their recommendations could include increasing warnings, seeking more studies, limiting who can use the drugs or how long they can be used or even ordering one or more off the market.
The evidence is suggestive that there is something going on with each of these drugs, but it is not conclusive, commented Thomas Fleming, chairman of the department of biostatistics at the University of Washington.
Dr. Steven Abramson, chairman of the division of rheumatology at the New York University School of Medicine, said it's possible the problems stem from the ability of these drugs to hamper the Cox-2 enzyme. But he also suggested a study to examine whether similar problems arise from other painkillers, such as ibuprofen.
Dr. Peter A. Gross, chairman of internal medicine at the Hackensack University Medical Center in New Jersey, worried that if the committee did conclude the heart problems were related to the Cox-2 action, patients would all switch to older drugs that can cause ulcers and bleeding problems.
Common sense decision making from the Feds? Amazing.
This is good news. My knees and the muscle behind my right knee offer their thanks.
Pretty serious charge. Proof?
I bet the trial lawyers are grinding their teeth as this lessens the argument that Vioxx was poison for all that took it.
They will have to spend more money planting made up horror stories on TV and in the press. Can't let potential jurors forget and not soak the drug companies. Trial lawyers need those big fees to buy fancy houses, jets, cars and mistresses.
everyone should just take enteric coated aspirin or buffered aspirin [ie, Ecotrin, Bufferin]
aspirin doesn't have a long duration of action but it goes to work quickly and it's dirt cheap
acetaminophen is a joke
when the pain is less severe tough it out
only take pain medications when you absolutely need them
these drugs that you can take 'just once a day' are not convenient or better than aspirin
it's just a marketing technique to get people buying the pills forever
somehow mankind survived for centuries before all of these medications were invented
whiskey is the original painkiller
My 93 yoa father, with severly advanced heart congestion, has taken vioxx and bextra for temporary problems on three seperate occasions. The last time was this past summer just before the announcement. He nor his cardiologist have seen any ill effects.
I would not hesitate to use it on a temporary basis. I still have a couple left from that 5-6 year old prescription that I'm saving for an emergency.
However, I would give careful thought on using it continuously
You're completely wrong.
For some types of issues, Celebrex etc. are almost a miracle.
My mother was suffering from arthritis and had difficulty walking until she started taking Celebrex. She became more mobile, was happier and enjoyed life again. When she stopped taking it, after a week or so she stiffened up and is hobbling along. Hope they find that Celebrex is ok. Advil is not doing the trick.
Well, I would say that when she put my hand over her heart and I felt her entire chest cavity convulsing, that was proof for me. But you miss my point. For her, the Vioxx was a GOOD thing, and despite what it did to her heart, it gave her more pain-free days than she's ever had. If it were available, she would still be using it.
Aspirin, ibuprofen, and acetominophen are WORTHLESS for the kinds of pain we're talking about. I have arthritis due to Crohn's Disease. Before I was diagnoses, I took very high doses of the coated versions of the above, but my joints became so swollen I couldn't even get on my comfy walking shoes. My wrists hurt to point of tears just opening the refrigerator, or holding a book. I didn't need Vioxx - feldene is sufficient for mine. But if feldene stops working and Vioxx is available, I will take it just to be able to function.
You are, of course, entitled to your opinion. But, in this case, you are ill-informed.
Check the Celebrex study; if memory serves, it was done using terminal cancer patients at 4 to 8 times the recommended dosage, and almost anything can cause problem when taken at high dosages.
Other studies have indicated a reduction of certain heart related issues -- apparently due to the anti-inflammatory characteristics.
Your mother might want to discuss the issue with her doctor.
My wife will start taking Vioxx again as soon as it is offered, knowing in advance the risks. For her it's a wonder drug.
Be careful of that expiration date. Many drugs lose their potency, or worse, become toxic. Ask a pharmacist to be sure.
Well, this pharmacist of 32 years agrees with you. But, I'm just an old guy.
Not to mention that short term use has been shown to be pretty much safe. There are certain injuries to which Vioxx works extraordinarily well, and people who want to take it for a few weeks should be able to.
My wife took vioxx for five years and was able to live a better life that she is today. She was taking a low dosage and never seemed to have a problem. She osteoarthritis what the drug was put on the market for. It work so well for this group of people it was being used as a pain killer. Celbrex does not work as well. She will gladly start taking the drug when it returns to the market.
I have a good friend who was hit by a car. He's told me that Vioxx was the only thing that helped his pain and that he'd take it even knowing the possible side effects.
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