Bextra Will Not Return In Canada As Safety Risks Outweigh Benefits

Health Canada Safety Panel Cites Heart Attacks, Strokes, and Severe Skin Reactions

Bextra, Pfizer's anti-inflammatory drug for arthritis patients, will not be returned to the Canadian market according to a Health Canada announcement in mid-December 2005.  Bextra was withdrawn voluntarily from the Canadian market in April 2005 by Pfizer after severe skin reactions affected seven people in Canada.

Citing the findings and recommendations of its expert safety panel, Health Canada said that the safety risks of Bextra outweighed its benefits.  In particular, Health Canada pointed out the serious cardiovascular risks associated with Bextra, including heart attack and stroke, and said that Bextra causes rare but severe and potentially fatal skin reactions more often than other drugs in its class.  Specifically, the severe skin reactions are erythema multiforme (EM), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN).

A Health Canada spokesman, Jirina Vlk, was quoted in a December 17, 2005 Toronto Star article: "We concluded that there is insufficient evidence to establish the safety of the drug for its recommended use."

Bextra is a COX-2 inhibitor.  This class of drugs includes Vioxx and Celebrex.  In September 2004 Vioxx, once the most popular painkiller in Canada, was pulled from the worldwide market.  Subsequent to the the Vioxx recall, new warnings about serious cardiovascular risks have been added to the package insert, or label, for Celebrex.

According to the Toronto Star article, in a written release, Pfizer Canada said "Bextra is an important treatment option ... (and) it should continue to be available for those patients who could benefit from it."

More information about this action as well as earlier actions by Health Canada concernng Bextra can be found in its December 16, 2005 Advisory, posted on the Health Canada web site.

(Posted by: Tom Lamb)