April 7, 2005Health Canada asked drug maker Pfizer on Thursday to immediately discontinue sales of its arthritis drug Bextra, the same day sales were suspended in the U.S. and Europe until concerns about its safety are cleared up.
Pfizer suspended sales of the drug in the United States and the European Union following a request from the U.S. Food and Drug Administration and European regulators.
In seeking Bextra’s withdrawal, Pfizer says the FDA cited a risk of the drug causing a potentially fatal skin reaction.
Pfizer says it disagrees with the FDA and Health Canada on Bextra’s safety.
Health Canada says it will request more safety information from Pfizer regarding Bextra.
The FDA also wants other drugs in the same class, known as COX-2 inhibitors, to carry the strongest possible safety warning about increased risk of heart attack and stroke. Pfizer’s Celebrex is included in that class, as well as Merck & Co.’s high-profile drug Vioxx.
The regulator said it called for Bextra’s withdrawal from store shelves because of the skin condition risk.
The FDA is also asking for strengthened warnings on Motrin, Advil and Aleveknown as over-the-counter non-steroidal anti-inflammatory drugs (NSAIDs)about the risks of cardiovascular problems and gastrointestinal bleeding. The warnings do not apply to Aspirin.
Celebrex, Vioxx and Bextra are selective NSAIDs, designed to prevent gastrointestinal bleeding.
The regulator has been studying the safety of COX-2 inhibitors since Merck & Co. pulled Vioxx from the market last September, citing research that showed links to an increased risk of heart attack and stroke.
The first COX-2 inhibitors were introduced to the market in 1999, promoted as safe, effective drugs that would target an enzyme responsible for pain and inflammation without causing stomach distress, as earlier generations of arthritis drugs had done.