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Other Cox-2 Drugs Present Same Safety Risks As Vioxx

Posted on: Thursday, 17 February 2005, 00:00 CST

Feb. 17--WASHINGTON --Top-selling Celebrex and Bextra share the same safety health risks as Vioxx, the widely prescribed painkiller Merck & Co. withdrew from the market last fall after a study linked the drug to heart attacks and strokes, advisers to the U.S. Food and Drug Administration were told Wednesday.

Evidence mounted against Pfizer Inc.'s Celebrex and Bextra on the first day of a three-day hearing examining the risks of so-called Cox-2 drugs, a class of drugs initially hailed by drug makers and doctors as safer on the stomach than older painkillers.

By Friday, the panel will issue recommendations on whether painkillers Celebrex and Bextra should remain on the market or whether stronger warning labels should be issued. The panel also could order additional studies that would specifically address heart risks.

The panel's advice to the FDA comes amid growing consumer angst over the agency's role in assuring drugs are safe and effective. On Tuesday, the FDA said it would establish a new oversight board to monitor U.S.-approved drugs once they go on the market.

For the first time, Merck on Wednesday said it believed cardiovascular risks may be part of a "class effect" for Cox-2s, a theory gaining momentum as additional research puts Celebrex and Bextra with Vioxx in the same bucket when it comes to safety issues linked to heart attack and stroke.

"We believe the data strongly suggest a class effect (from Cox-2 inhibitors)," Dr. Ned Braunstein, senior director of Merck research laboratories, told the panel.

The idea of a class effect puts more pressure on the FDA, which asked the panel to describe the specific patient population that would benefit from Cox-2 should they remain on the market. Such a recommendation is important for patients taking Cox-2s, especially given an increasing number of studies showing the drugs aren't any better for patients at combating pain than older remedies.

Merck's testimony before a high-profile panel discussing the safety of Cox-2s doesn't necessarily bode well for the company even with Vioxx off the market. Merck has a second Cox-2 drug, Arcoxia, in development and its chance of winning FDA approval is in doubt, researchers testified Wednesday.

"We're likely to subject new drugs that might be approved in this class to significant hurdles before they are approved," said University of Pennsylvania professor Dr. Garret FitzGerald. He published some of the earliest research on the potential cardiovascular risks of Cox-2 painkillers and was invited by the FDA to testify at the advisory panel.

Much is at stake for New York-based Pfizer, which generated more than $5 billion last year in worldwide sales from Celebrex and Bextra. The world's largest pharmaceutical company can ill afford to sustain major losses in sales of those two drugs with key products facing increasing competition and loss of patent protection.

Kenneth Verburg, a Pfizer vice president, vowed to escalate studies of cardiovascular risks of its Cox-2 drugs. Pfizer has stood by earlier statements that Vioxx was distinctly different from Celebrex and Bextra in its chemical makeup.

"Pfizer is trying to convince a very smart group of people that these drugs are different than the Cox-2 already withdrawn from the market," said Dr. James Rippe, a cardiologist and associate professor from Tufts University in New Orleans. "This is a clash of the titans between Merck and Pfizer."

Rippe also is a paid consultant to Bayer AG, maker of the popular over-the-counter painkiller Aleve. Bayer, too, may have some sales at stake.

The over-the-counter drug Aleve is part of the older class of drugs known as a non-steroidal anti-inflammatory that was cited for a potential cardiovascular risk in a widely reported study late last year.

Aleve, though, has largely been vindicated by studies presented to the panel. Researchers attending the meeting don't expect the panel to toughen labeling on Aleve, analysts said.

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Source: Chicago Tribune

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