Stop-sale Order on Bextra in Canada

28 Dec 2005  Following a review of safety information, Health Canada is informing the public that Bextra, an anti-inflammatory drug used to treat arthritis and pain, will not return to the market. The manufacturer voluntarily suspended sales of Bextra in April 2005 due to safety concerns related to rare but serious skin reactions and cardiovascular problems. Health Canada issued a stop-sale order which ensured that Bextra (the brand name for valdecoxib) would not return to the market without further consultation with Health Canada. Bextra is one of a small group of drugs called COX-2 selective inhibitor non-steroidal anti-inflammatory drugs. A review of the available evidence for other drugs from this group indicates that there is an increased risk of heart attack and stroke when these drugs are used for long-term treatment. Studies also showed that these side-effects can occur when Bextra is used for short-term pain relief following high-risk heart surgery. Bextra is also associated with a risk of rare but severe and potentially fatal skin reactions. The decision to stop the sale of Bextra is based on information submitted by the manufacturer, Pfizer Canada Inc., and consultations with external experts and the public. Health Canada concluded that there is insufficient evidence to establish the safety of the drug for its recommended use.