Posted on 02/18/2005 12:16:45 PM PST by freespirited
WASHINGTON - Advisers to the Food and Drug Administration (news - web sites) concluded Friday the popular painkiller Celebrex poses an increased risk for heart problems but should remain on the market because the benefits outweigh the dangers.
The panelists suggested a number of possible restrictions, including placing a "black box" warning on the label warning of the potential dangers and who's at risk, providing more patient information with the drug, restricting which patients could get it and banning direct-to-consumer advertising for Celebrex.
The FDA is not bound to follow any of the recommendations. If it does decide to keep the drug on the market, it then will determine what if any of the restrictions should be imposed.
The FDA's arthritis and drug safety advisory committees, concluding three days of meetings to assess the risks of three popular painkillers called Cox-2 inhibitors, were to address Vioxx and Bextra later in the day. All three drugs have been approved for sale by the government, though all have been linked to increased risk of heart attacks and strokes.
Meeting Chairman Alistair J.J. Wood of Vanderbilt University Medical School said it is important to find some way to help the public better understand the nature of risk. In the case of Celebrex, he estimated people who take it have a 1 percent higher risk of heart problems than people who don't.
Panelists suggested the drug be limited to 200 milligrams for people who can't take other painkillers for various reasons or who don't respond well to other products. Heart trouble began to appear in colon polyp study patients who took Celebrex doses of at least 400 milligrams.
Dr. Steven Nissen, medical director of the heart center at the Cleveland Clinic said, "What we really want is to make sure it's available for patients that need it and is unavailable to patients who whom it's inappropriate."
The committees were asked to assess the drugs after Merck & Co. pulled Vioxx from the market last fall because of health concerns. Since then questions have been raised about Bextra and Celebrex, both made by Pfizer Inc.
Shares of Pfizer rose 76 cents, or 3 percent, to $25.82, following the announcement, while Merck shares gained $1.23, or 4.3 percent, to $30.08, both on the New York Stock Exchange.
Earlier in the meeting, Wood said the safety problems reported in connection with Cox-2 inhibitors exceed those of products that have been withdrawn from the market.
However, since the side effect involving heart attacks, irregular heartbeat and stroke is a relatively common problem, that makes it harder to pin it to the drugs than if it were a rare side effect.
Dr. Peter S. Kim, president of Merck Research Laboratories, had told the FDA committees earlier that new studies indicated the side effects aren't unique to its product.
Kim also indicated a positive assessment by the FDA panelists might lead Merck to consider bringing Vioxx back onto the market.
"There are unique benefits to Vioxx," he said. "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.
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.
Dr. Robert Temple, director of medical policy for the FDA's Center for Drug Evaluation and Research, told the committees on Friday that "the idea of doing a large new study has weight."
"There are some data we'd all like to have, that we don't have," Temple said, including the blood pressure and other effects of the various drugs.
He said a new study might include more than just the Cox-2 drugs, possibly adding such widely used painkillers as ibuprofen, naproxen and diclofenac.
"My main point is that there is a very important need for more information on many of these drugs," Temple said.
Thanks for the post. I know several people who used to use all three products--Vioxx, Celebrax and Bextra.
There are natural ways to CURE arthritis but the dumbed down public buys this nonsense. The truth is these drugs are dangerous in many ways and they only mask symptoms.
Yep-with all those side effects, they should put a skull and crossbones on the package instead of a "black box"-I'll just use those natural remedies and exercise.
These drugs do nothing to restore health. They only treat symptoms, and at a large cost.
I can go on and on but this is a start.
I took it back in 2001, during my first Festival season, when I hurt my shoulder in combat practice. It worked better than any anti-inflammatory ever has.
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