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CELEBREX (celecoxib) Capsules Important Safety Information

A Selective Cyclo-oxygenase-2 (COX-2) Inhibitor Non-Steroidal Anti-Inflammatory Drug (NSAID)

Dec 20, 2004 | HEALTH CANADA

Dear Healthcare Professional,

Pfizer Canada Inc., following discussions with Health Canada, would like to inform you of important new safety information for CELEBREX* (celecoxib) capsules.

On December 16, 2004, Pfizer, Inc. received new information related to the cardiovascular safety of its COX –2 inhibitor Celebrex (celecoxib). This new information is based on an analysis of two long-term colon cancer prevention trials.

The Data Safety Monitoring Board reviewing these studies informed Pfizer that their review indicated one of the studies (the Adenoma Prevention with Celecoxib [APC] cancer prevention trial) demonstrated an increased cardiovascular risk when compared to placebo, while the other trial (the PreSAP cancer prevention trial) revealed no greater cardiovascular risk than placebo.

In the Adenoma Prevention with Celecoxib (APC) trial, patients taking 400mg and 800mg of CELEBREX daily had an approximately 2.5 and 3.4 fold increase, respectively, in their risk of experiencing a major fatal or non-fatal cardiovascular event compared to those patients taking placebo, according to the National Cancer Institute (NCI).

The information from these trials was received by Pfizer on the night of 16 December 2004 has been shared by the company with Health Canada, the U.S. FDA, as well as the EMEA.

Based on the statistically significant findings associated with the APC trial:

Dosing of CELEBREX has been suspended in both trials. At this time, Pfizer does not have detailed access to the actual data and analyses upon which the decision of the Data Safety Monitoring Board have been based. Pfizer expects to receive these data shortly. Pfizer is taking immediate steps to fully understand the results and rapidly communicate new information to regulators, physicians and patients.

Health Canada has suspended the market authorization (Notice of Compliance with Conditions) for the use of CELEBREX to reduce the number of adenomatous colorectal polyps in patients with Familial Adenomatous Polyposis (FAP) for reasons related to safety as noted above.

Pfizer therefore requests that physicians immediately contact all patients currently using CELEBREX in FAP and advise them to immediately discontinue the medication. Physicians should continue to observe these patients according to standard medical practice.

Physicians should consider this evolving information in evaluating the risks and benefits of CELEBREX in individual patients treated for OA, RA or acute pain. Factors to be considered include: this new information concerning long-term use; the existing body of data which currently exists for CELEBREX; and the risk of gastrointestinal ulcers and bleeding.

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