2 - FYI

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COX-2 INHIBITOR CLASS OF DRUGS SHOULD BE REVIEWED FOR CARDIAC SAFETY,

RESEARCHERS SUGGEST

Shares of several drug companies fell Thursday following an article released on

Wednesday calling for a review of other members of the COX-2 inhibitor class of

drugs beyond Merck & Co. Inc.'s Vioxx (rofecoxib) to evaluate whether they, too,

pose an increased risk of cardiac problems. Also criticized in a related article

was the lack of earlier appropriate action by the Food and Drug Administration

with respect to the Vioxx situation.

The reports, which were published Oct. 6 on the Web site of The New England

Journal of Medicine ahead of the Oct. 21 print edition, draw attention to the

notion that the increased risk of cardiac events among Vioxx users, which led

Merck to voluntarily withdraw the drug last week, may extend to the entire COX-2

inhibitor class of drugs.

" t is essential to determine whether the cardiovascular risk is or is not a

class effect, " wrote Dr. Garrett Fitzgerald, a cardiologist with the University

of Pennsylvania School of Medicine.

In another article, cardiologist Dr. Topol suggested the FDA's " passive

position " of waiting for data to accrue is not acceptable " given the strong

signals that there was a problem and the vast number of patients who were being

exposed. "

The only other Food and Drug Administration-approved drugs in this class that

are currently available are Pfizer Inc.'s Celebrex (celecoxib) and Bextra

(valdecoxib). Novartis AG's Prexige (lumiracoxib) is awaiting FDA approval.

Also on Wednesday, the European Medicines Agency said it would review all drugs

in this class in the wake of Merck's withdrawal of Vioxx.

However, Pfizer's medical director, Dr. Gail Cawkwell, said there is no evidence

of increased risk of heart problems among the 75 million Americans who have

taken Celebrex, according to The Associated Press.