Health Canada won’t allow Bextra back on shelves
Reported July 2, 2007
TORONTO — The painkiller Bextra will not be allowed back on the Canadian market, Health Canada announced Friday.
In barring the return of the drug, Health Canada is following the advice of an expert panel, which after reviewing evidence and holding public hearings, concluded Bextra should not be sold in this country.
Bextra is a member of a class of drugs known as cox-2 inhibitors. Better known cox-2s are Celebrex, which is still sold, and Vioxx, which was pulled from worldwide markets in late September 2004.
Drug maker Pfizer Canada voluntarily suspended sales of Bextra last April, based on reports the drug caused rare but potentially fatal skin reactions in addition to raising risks of cardiovascular events like heart attack and stroke — a risk linked to all drugs in this class.
Health Canada responded by issuing a stop-sale order which ensured Bextra could not be returned to the market without the department’s approval, and has been studying data supplied by the manufacturer as part of its review of all the cox-2 drugs.
“Health Canada concluded that there is insufficient evidence to establish the safety of the drug for its recommended use,” the department said in a release.
Cox-2 drugs stormed the painkiller market in the late 1990s based on claims they were more effective than traditional non-steroidal anti-inflammatory drugs and were less likely to cause the stomach bleeding associated with use of those older painkillers.
The integrity of a number of the studies used to create that marketing pitch have subsequently been challenged. And new studies have confirmed that use of the drugs increases the risk of heart attack and stroke.