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Vioxx recalled.

In the fall of 2004, Merck announced the withdrawal of Vioxx, its leading drug for the management of rheumatoid arthritis. The decision came about over concerns with an increased risk of heart attack and stroke compared with placebos in a trial.

The Food and Drug Administration (FDA) first approved Vioxx, a nonsteroidal anti-inflammatory drug (NSAID) with an inhibitory action against cyelooxygenase-2 (COX-2) for osteoarthritic-related pain and inflammation, and subsequently to treat rheumatoid arthritis. Vioxx seemed advantageous over other NSAIDs such as naproxene and ibuprofen, which are associated with increased risk of GI ulcers and bleeding.

Merck had submitted to the FDA in June of 2000 a study showing that patients taking Vioxx had fewer GI side effects than patients taking naproxene.

But crucially, the same study disclosed a four-fold increase of myocardial infarction (heart attack) in people taking Vioxx.

Celebrex, another COX-2 inhibitor, is marketed by Pfizer. Pfizer stood firm by its product, saying three studies involving 6,000 people found no link between the drug and an increased risk of heart disease--such a link was found for another Pfizer drug, Bextra, in patients after bypass surgery.

The data on Celebrex will only become available next year.
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Publication:Medical Update
Article Type:Brief Article
Geographic Code:1USA
Date:Nov 1, 2004
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