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Title: Celebrex (Celecoxib) Not Associated With Increases In Stroke Or Heart Attacks
URL: http://www.pslgroup.com/dg/1CEE0A.htm
Doctor's Guide
April 28, 2000


PEAPACK, NJ -- April 28, 2000 -- Recent news reports have associated Vioxx (rofecoxib), a treatment for osteoarthritis and pain, with stroke and heart attacks. It has been suggested that this may be an effect common to COX-2 inhibitor compounds. However, new data reaffirm that this is not the case for Pharmacia Corporation's innovative COX-2 specific inhibitor, Celebrex(R) (celecoxib capsules).

A landmark study just released continues to demonstrate a strong safety profile for Celebrex, which is not only indicated for osteoarthritis but also rheumatoid arthritis.

The long-term, 13-month outcomes study compared 4,000 patients taking very high doses of Celebrex (four times the usual osteoarthritis dose) with 2,000 patients taking prescription daily doses of ibuprofen, and 2,000 patients taking prescription daily doses of diclofenac. Ibuprofen and diclofenac are two of the most commonly prescribed conventional NSAID therapies for arthritis pain and inflammation.

Even at these very high doses, Celebrex showed no increases in stroke or heart attack with or without aspirin. The Celebrex data thus indicate that there is no class-related issue on this important safety parameter, suggesting that any potential risk associated with Vioxx may be specific to that compound.

Patients who have a known allergic reaction to celecoxib, certain sulfa drugs called sulfonamides, aspirin or NSAIDs should not use Celebrex. Celebrex does not affect platelet function and therefore should not be used for cardiovascular prophylaxis. As with all NSAIDs, Celebrex should be used with caution in patients with fluid retention, hypertension, or heart failure. In studies, the most common side effects of Celebrex were dyspepsia, diarrhea and abdominal pain, which were generally mild to moderate.

Celebrex is co-promoted by Pharmacia Corporation and Pfizer Inc.

Pharmacia Corporation is a leading global pharmaceutical company created through the merger of Pharmacia & Upjohn with Monsanto Company and its G.D. Searle unit. Pharmacia has a broad product portfolio, a robust pipeline of new medicines, and an annual investment of more than $2 billion in pharmaceutical research and development. In its Monsanto subsidiary, Pharmacia has one of the world's leading fully integrated agricultural businesses.

Pfizer Inc. is a research-based, global pharmaceutical company that discovers, develops, manufactures and markets innovative medicines for humans and animals. The company reported revenues of more than $16 billion in 1999 and expects to spend about $3.2 billion on research and development this year.

Related Links: Celebrex (celecoxib), Pharmacia Corporation and Pfizer Inc.

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