rofecoxib, Vioxx

Discontinued Warning Icon Please Note: This Drug has been voluntarily withdrawn from the market.

GENERIC NAME: rofecoxib


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To view the FDA press release, please see the recall posting "Vioxx Withdrawn From Market."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



PREPARATIONS: Tablets: 12.5 mg, 25 mg, and 50mg. Oral Suspension: 12.5 mg/5 mland 25mg/5ml

STORAGE: Store at room temperature, 15-30°C (59-86°F)

PRESCRIBED FOR: Rofecoxib is used for treating the pain, swelling, and tenderness caused by osteoarthritis and rheumatoid arthritis in adults. Rofecoxib is also used for treating acute pain such as headache and menstrual cramps.

DOSING: The lowest effective dose should be used. For the management of osteoarthritis, the usual dose is 12.5 mg (tablet or suspension) once daily. The maximum dose is 25 mg once daily. For the treatment of acute pain and menstrual cramps the usual dose is 50 mg once daily. It may be taken with or without food.

DRUG INTERACTIONS: Concomitant use of rofecoxib with aspirin or other NSAIDs (e.g., ibuprofen, naproxen, etc.) may increase the occurrence of stomach and intestinal ulcers. Since NSAIDs may increase the concentration of lithium in the body, lithium levels should be monitored during and after therapy with rofecoxib.

Rofecoxib may accentuate the effect of the anticoagulant (blood thinner) warfarin (Coumadin), and promote bleeding. Persons taking warfarin should have the clotting of their blood tested, particularly during the first few days after starting or stopping rofecoxib.

Rifampin decreases the concentration of rofecoxib in the body by 50% and thus may reduce the effectiveness of rofecoxib.

Rofecoxib may increase the concentration of methotrexate by 23% and may lead to increased side effects of methotrexate. Persons taking both drugs should be closely monitored for these side effects.

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