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.
As a result of this regulatory action, the manufacturer will not be able to bring Bextra back onto the Canadian market under its present conditions of use. Health Canada has sent a letter to inform Pfizer Canada Inc. of the status of Bextra.
Following the voluntary withdrawal of another COX-2 selective inhibitor, Vioxx, from the worldwide market on September 30, 2004, a team of Health Canada experts initiated a review of related drugs to determine whether they had a risk of similar cardiovascular side-effects. Health Canada consulted external experts and the public as part of the COX-2 Expert Advisory Panel that met in June 2005.
Health Canada has completed the review and agrees with the panel that available evidence indicates that COX-2 selective inhibitors and all other non-steroidal anti-inflammatory drugs are associated with an increased risk of cardiovascular events when high doses are used for long periods. However, the exact nature of that increased risk may differ from one product to another. The panel also found that the overall risk versus benefit profile for Bextra does not support the marketing of this drug in Canada under its current conditions of use.