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Subscribe To Our Syndicated NewsCanada Refuses to Bring Bextra Back
-December 19, 2005
Last Friday, Health Canada (the Canadian equivalent to the FDA) announced the government would not allow Bextra to re-enter the market. This Canadian Bextra announcement follows the advice of an expert medical panel that, after holding public hearings and reviewing medical evidence, decided Bextra was too dangerous to be sold to consumers.
Bextra is the second COX-2 non-steroidal anti-inflammatory drug (NSAID) to be pulled off the market due to serious side effect concerns. Merck pulled Vioxx from the market worldwide after studies found use of the drug for 18 months doubled one's risk of heart attack and stroke. Pfizer pulled Bextra off the market in April 2005 due to similar cardiovascular risks and the seemingly unique risk of serious skin reactions. Celebrex, also made by Pfizer, is the only drug in this class to remain on the market.
Pfizer Canada pulled Bextra off the market in April and the government issued a stop-sale order ensuring the drug would not be returned to the market without agency approval. Health Canada has since been studying the available Bextra safety data. In a department press release, the agency stated, "There is insufficient evidence to establish the safety of the drug for its recommended use."
Prior to the recall of Cox-2 painkillers, these drugs were aggressively marketed as being more effective than traditional painkillers and less likely to cause gastrointestinal side effects associated with older NSAIDs like ibuprofen and naproxen. The studies used to develop this marketing pitch have been highly scrutinized since new studies have found evidence to the contrary.
Thousands of injured consumers worldwide have filed lawsuits against the makers of these harmful painkillers. In the United States, consumers who allegedly suffered serious Vioxx side effects have filed at least 7,000 lawsuits against Merck. Hundreds more Bextra side effect victims have filed similar lawsuits against Pfizer.
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