Article reference:

Pain Killers Face Review for Heart Risks

Wed Feb 16, 2005 7:14 AM ET
By Lisa Richwine

WASHINGTON (Reuters) - Medicines used by millions of Americans to relieve aches and pains will come under intense scrutiny starting Wednesday as U.S. scientists scour dozens of studies to determine if the drugs risk damaging the heart like Merck & Co. Inc.'s withdrawn arthritis pill Vioxx.

The unusual three-day public review was prompted by Merck's recall of Vioxx in September after a study showed the drug doubled heart attack and stroke risk in patients who took it for at least 18 months.

Since then, questions have arisen about Pfizer Inc.'s similar pain pills, Celebrex and Bextra, as well as nonprescription therapies such as naproxen.

The Food and Drug Administration is asking two outside advisory committees if Celebrex and Bextra offer enough benefits to stay on the market, if any pain relievers need stronger warnings and what further research is needed.

"I believe Pfizer has a solid enough case to keep Celebrex on the market" with a new warning about possible cardiovascular risk, said Robert Hazlett, an analyst with Suntrust Robinson Humphrey.

"We're hopeful Bextra can dodge any bullets, but that's less clear," Hazlett said.

Pfizer recently added a warning to Bextra's label about the potential for heart problems.

With Celebrex, the company says an analysis of 41 studies concluded the drug did not appear to increase the chances of heart attacks or other serious cardiovascular problems.

Celebrex, Bextra and Vioxx are part of the COX-2 family of drugs that were designed to relieve pain like older drugs such as aspirin and ibuprofen, while being easier on the stomach. The older, nonprescription medicines can cause potentially fatal stomach and intestinal bleeding.

Friedman, Billings, Ramsey analyst David Moskowitz said Merck will face some heat at the meeting for its handling of Vioxx.

"There was a lot of evidence out there that Vioxx was dangerous, and Merck is really going to have to own up to that throughout these next couple of days," Moskowitz said.

Merck has said it acted appropriately and voluntarily recalled Vioxx once the heart risks became clear.

The advisory panels also will review data on Merck's Arcoxia and Novartis AG's Prexige - two COX-2 inhibitors the companies are trying to get on the U.S. market.

The meeting also is important to GlaxoSmithKline Plc, which is developing a COX-2 inhibitor known as '381, and is awaiting direction on its final phase of studies.

Criticized for not being quicker to catch the side effects of drugs already on the market, the FDA on Tuesday announced the creation of a new drug safety oversight board.

(Additional reporting by Bill Berkrot in New York)