FDA Panel: Vioxx, Celebrex, Bextra Pose Heart Risks, Can Stay on Market

Withdrawn arthritis drug Vioxx (search) may make a comeback on the market after advisers to the Food and Drug Administration (search) narrowly voted it was safe enough to be sold despite an increased risk of heart attack and stroke.

The FDA panel concluded Friday that popular painkillers Vioxx, Celebrex (search) and Bextra (search) pose an increased risk for heart problems but should remain on the market because the benefits outweigh the dangers.

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 17-15.

Vioxx is substantially worse than the others, panel chairman Alistair J.J. Wood of Vanderbilt University School of Medicine said. "The data is very compelling," Wood said.

Vioxx is manufactured by Merck and Co. (MRK) while Celebrex (search) and Bextra (search) are manufatured by Pfizer Inc. (PFE). Merck stocks soared 13 percent to $32.61 on the New York Stock Exchange. Pfizer gained 6.9 percent to close at $26.80.

It was a stunning turnaround for Vioxx, which was withdrawn in September by Merck after a study showed Vioxx doubled heart attack and stroke risk compared to a placebo.

"Merck has appreciated the opportunity to present data at this advisory committee meeting," the company said in a statement. "We look forward to discussions with the FDA."

The FDA usually follows advice from its panels. Officials have said the agency will make final decisions on Celebrex and other pain relievers in a matter of weeks. All three drugs are part of a class called Cox-2 inhibitors (search).

The panelists 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.

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.

Wood of Vanderbilt University Medical School (search) 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 (search), 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 pulled Vioxx from the market last fall because of health concerns. Since then questions have been raised about Bextra and Celebrex.

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.

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.

Reuters and the Associated Press contributed to this report.