http://www.cnn.com/2005/HEALTH/condi....ap/index.html
FDA panel: Keep Vioxx, Celebrex, Bextra on market
Advisory group says there are risks but benefits outweigh them
Friday, February 18, 2005 Posted: 3:55 PM EST (2055 GMT)
WASHINGTON (AP) -- The popular painkillers Celebrex, Bextra and Vioxx all pose a risk of heart trouble, but should be available to those who need them, advisers to the Food and Drug Administration said Friday.
The panel strongly favored keeping Celebrex on the market, split over Bextra and favored Vioxx -- which is currently not on sale -- by a vote of just 17-16.
"The data is very compelling," Vioxx is substantially worse than the others, meeting chairman Alistair J.J. Wood of Vanderbilt University School of Medicine said.
The panelists voted 31-1 to keep Celebrex on sale and, after a revote, favored Bextra 17-13 with two abstaining.
The FDA is not required to follow the recommendations of the panel, but generally does so.
At the opening of the three-day meeting, FDA officials promised a prompt response to the panel's suggestions, which it requested after studies began showing problems with the drugs.
The panelists were unanimous in saying the drugs, known as Cox-2 inhibitors, pose risks of heart trouble. Studies of Bextra were limited, but showed a greater risk than Celebrex, the committee noted.
The advisers suggested restrictions on the drugs such as placing a severe "black box" warning on them, including more patient information with the drugs, restricting which patients could get the drugs and possibly banning direct-to-consumer advertising for the products.
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.
"People worry about crime and then drive drunk," he said, indicating they don't really understand relative risks.
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 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.
The advisers also were set to frame recommendations to the FDA about whether further testing is needed for the drugs and any special warnings or limits placed on them.
"We need to find the unique patients that will benefit from this drug and work out what they need to be told," said Wood.
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.
The excess risk from Celebrex varied in different studies and the panel didn't seek to determine just how much more hazard a user faces than someone on another drug.
However, the panel was told that no cardiovascular problems were seen at the normal prescription dose of 200 milligrams. Heart trouble began to appear in colon polyp study patients who took 400 milligrams.
Merck stock shot up nearly 12 percent in the minutes following the announcement, increasing $3.35 to $32.20 per share in afternoon trading on the New York Stock Exchange. Pfizer shares rose $1.39, or 5.6 percent, to $26.45 on the NYSE.
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.
"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 noted that Vioxx seemed to have more such reports than the other drugs.
On the other hand, Kim said, 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.
FWIW, Peregrino
Linear Mode
