rofecoxib, Vioxx

Discontinued Warning Icon Please Note: This Drug has been voluntarily withdrawn from the market.

GENERIC NAME: rofecoxib

BRAND NAME: Vioxx

IMPORTANT NEWS ALERT - September 30, 2004 the Food and Drug Administration (FDA) today acknowledged the voluntary withdrawal from the market of Vioxx (chemical name rofecoxib), a nonsteroidal antiinflammatory drug (NSAID) manufactured by Merck & Co. FDA today also issued a Public Health Advisory to inform patients of this action and to advise them to consult with a physician about alternative medications.

Merck is withdrawing Vioxx from the market after the data safety monitoring board overseeing a long-term study of the drug recommended that the study be halted because of an increased risk of serious cardiovascular events, including heart attacks and strokes, among study patients taking Vioxx compared to patients receiving placebo. The study was being done in patients at risk of developing recurrent colon polyps.

To view the FDA press release, please see the recall posting "Vioxx Withdrawn From Market."

DRUG CLASS AND MECHANISM: Rofecoxib is a nonsteroidal anti-inflammatory drug (NSAID) that is used to treat pain, particularly the pain of osteoarthritis and menstrual cramps. Prostaglandins are chemicals that are important in promoting inflammation and its signs--pain, fever, swelling and tenderness. Rofecoxib blocks the enzyme that makes prostaglandins (cyclooxygenase- 2) and thereby reduces the amounts of prostaglandins. As a consequence, inflammation and its accompanying pain, fever, swelling and tenderness also are reduced. Rofecoxib is similar to celecoxib (Celebrex). Both drugs differ from other NSAIDs in that they cause less irritation and ulceration of the stomach and intestine (at least during short-term treatment), and they do not interfere with the clotting of blood.



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