FDA Staff Questions Heart Risks of Merck's Arcoxia

Merck & Co. Inc.'s painkiller Arcoxia offers a "marginal" advantage in gastrointestinal safety but seems "worse than" other pain drugs in terms of deaths and serious cardiovascular problems, U.S. regulatory staff said in documents released on Friday.

Merck conducted studies on Arcoxia comparing it to a placebo, naproxen and other medicines known as nonsteroidal anti-inflammatory drugs.

"The results appear to demonstrate that (Arcoxia) is worse than each comparator" with regard to deaths and serious cardiovascular problems, Food and Drug Administration staff reviewers wrote in an analysis posted on the agency Web site.

The FDA told Merck last October Arcoxia was "approvable" after additional safety and effectiveness data were reviewed. The agency will seek input later this month from an outside advisory panel on the risks and benefits of Arcoxia and other painkillers.

Arcoxia is Merck's successor to Vioxx, the arthritis drug the company pulled from the market last year after it was linked to heart attacks and strokes. Both drugs are part of a class called COX-2 inhibitors.

In a separate analysis, FDA reviewers said an experimental COX-2 inhibitor called Prexige, made by Novartis, showed it was safer on the gastrointestinal tract than other pain drugs. But the risks of heart attacks, strokes and deaths was "similar" to what was seen with Vioxx, the FDA reviewers said.

Reuters 2/4/05