Bextra’s Return Barred by Health Canada

posted on:
December 17, 2005


The painkiller Bextra will not be allowed back on the Canadian market, Health Canada announced yesterday.

In barring the return of the drug, Health Canada is following the advice of an expert panel, which, after reviewing evidence and holding public hearings, concluded Bextra should not be sold in this country.

Bextra is a member of a class of drugs known as cox-2 inhibitors. Better known cox-2s are Celebrex, which is still sold, and Vioxx, which was pulled from worldwide markets in September 2004.

Drug maker Pfizer Canada voluntarily suspended sales of Bextra last April at the request of Health Canada.

The agency was concerned about reports the drug caused rare but potentially fatal skin reactions in addition to raising risks of cardiovascular events such as heart attack and stroke—a risk linked to all drugs in this class.

Following Pfizer’s sales suspension, Health Canada issued a stop-sale order which ensured Bextra could not be returned to the market without the department’s approval. The department has been studying data supplied by the manufacturer as part of its review of all the cox-2 drugs.

“Health Canada concluded that there is insufficient evidence to establish the safety of the drug for its recommended use,” the department said in a release.

Pfizer, which disagrees with Health Canada’s assessment of Bextra’s risk-benefit ratio, said it was disappointed by the decision.

“There are more than four million Canadians who suffer from arthritis. Bextra is an important treatment option for them and Pfizer believes it should continue to be available for those patients who could benefit from it,” the company’s statement said.

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