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May 1999

Dear Health Care Professional:

Searle and Pfizer would like to inform you about an update in the product labeling for CELEBREX (celecoxib capsules), that you should consider when prescribing for a small portion of the patient population.

In patients receiving CELEBREX concurrently with warfarin there have been infrequent post-marketing reports of increases in prothrombin time, sometimes associated with bleeding events, predominantly in the elderly. As you know, the warfarin label advises close and ongoing medical management of warfarin "whenever other medications are initiated, discontinued or taken irregularly," given the increased potential for bleeding. The warfarin label indicates potential interactions with more than a hundred compounds.

CELEBREX is indicated for relief of the signs and symptoms of osteoarthritis (OA) and adult rheumatoid arthritis (RA).

CELEBREX, by itself, has no effect on platelet aggregation or bleeding time at therapeutic doses and may be an appropriate treatment option in patients taking warfarin, when anti-inflammatory therapy is indicated. It is important to note that CELEBREX can be continued or initiated with warfarin when patients are monitored appropriately for changes in anticoagulant activity, particularly in the first few days. It is estimated that approximately one percent of patients on CELEBREX also take warfarin, with a smaller subset of that group reporting increases in prothrombin time.

In order to communicate this important information to healthcare professionals, the warfarin section under the PRECAUTIONS heading in the revised package insert for CELEBREX (see enclosed for full revised label) now reads:

Since CELEBREX was approved by the FDA on December 31, 1998, more than 4 million prescriptions have been dispensed. The overall general safety profile of CELEBREX remains unchanged, and post-marketing experience is otherwise consistent with the safety and efficacy demonstrated in our extensive clinical trial program.

For more information about the updated package insert, please contact 1-877-CELECOXIB (1-877-235-3269).

You can also assist us in monitoring the safety of CELEBREX (celecoxib capsules) by reporting all adverse events to:

Searle Health Information Services:

or to the FDA MEDWATCH program:

Sincerely,

Alfonso Bello, MD, MHS, FACR
Associate Medical Director
Global Medical Operations
Searle