Health Canada Revisions to Celebrex Label Accepted by Pfizer Canada

On September 21, 2005 Pfizer Canada announced the drug company had agreed to make changes suggested by Health Canada that add new safety guidelines to the package insert for its arthritis drug Celebrex.

The newly revised package insert for Celebrex in Canada will contain the following safety guidelines:

• Celebrex should not be used before or after heart surgery;
• Celebrex should not be used in patients who are in a late-stage pregnancy;
• Celebrex should be used with caution by patients who have had heart attacks;
• Celebrex should be used with caution by patients who have high blood pressure; and,
• Celebrex should be prescribed and used at the lowest effective dose for the shortest possible duration.

Health Canada began its safety review of COX-2 inhibitors in the fall of 2004, after Vioxx was recalled following news about a study which showed that Vioxx increased the risk of heart attack and stroke.  The COX-2 class of drugs includes Celebrex and Bextra, also.  In the summer of 2005, Health Canada advisers met to study the side-effect risks of Celebrex and Bextra, along with Vioxx.  Ultimately, these advisers recommended in July 2005 that Celebrex be allowed to stay on the Canadian market, that Bextra should be kept off, and, surprisingly, that Vioxx should be allowed to return to the market in Canada.

On September 21, 2005, also, Health Canada sent an alert to doctors and patients that it had posted an "Important Safety Information on Celebrex (celecoxib)" bulletin on its web site.  The bulletin included a copy of the new Celebrex "Dear Doctor" letter as well as a a summary of the label changes for patients.

(Posted by: Tom Lamb)