Bextra, an anti-inflammatory drug for arthritis sufferers, will not be allowed back on the Canadian market.
Based on recommendations from an expert safety panel, Health Canada said yesterday the cardiovascular risks of the drug, including heart attack and stroke, outweighed its benefits.
Officials said it also causes rare but severe and potentially fatal skin reactions more often than other drugs in its class.
“We concluded that there is insufficient evidence to establish the safety of the drug for its recommended use,” said spokesperson Jirina Vlk.
Bextra was withdrawn voluntarily from the market in April by drug giant Pfizer after severe skin reactions affected seven people in Canada.
The drug falls into the same controversial class of drugs as Vioxx and Celebrex, known as cox-2 inhibitors. Vioxx, once the most popular painkiller in Canada, was pulled from the worldwide market in September 2004.
New warnings of cardiovascular risks have subsequently been issued for Celebrex.
In a written release, Pfizer Canada said “Bextra is an important treatment option … (and) it should continue to be available for those patients who could benefit from it.”
A Health Canada expert safety panel issued a report last summer recommending Vioxx be allowed back on the market.
However, panel members in an 8-5 vote said Bextra should not be. Bextra was approved for sale in December 2002 and 665,783 prescriptions were filled in Canada last year.