Canada Panel Backs Vioxx Return

Health Canada said it will "continue its assessment" about whether Bextra should return to the market, noting that the panel's recommendation is a "key factor" in a decision that should be made in a few weeks.

Calls to Pfizer were not returned in time for deadline on Thursday.

The Canadian medical advisory panel was convened, much like an FDA advisory committee was convened in February, to examine Vioxx, Bextra, Celebrex and other pain relievers known as Cox-2 inhibitors.

By narrow margins, the FDA advisory panel recommended that Vioxx be returned to the market and that Bextra be allowed to stay on the market with tight restrictions. The panel voted 31-1 that Celebrex remain available in the U.S. market.

But in early April, the FDA asked Pfizer to suspend sales of Bextra and asked the makers of Celebrex and older arthritis medications to place stronger warning labels on their products relating to potential cardiovascular risks. The FDA also asked the makers of over-the-counter pain relievers to add warnings to their labels about risks of cardiovascular problems and gastrointestinal bleeding.

The Canadian medical advisory panel said Thursday that Cox-2 drugs "increase the risk" of heart attacks and stroke in tests comparing patients taking Cox-2 drugs vs. patients taking placebos. The risk is greater among patients who take the drugs for a long time and who have a history of heart disease risk factors, the panel said.

However, it added that this risk "seems similar to the increased risk" associated with most of the older pain relievers known as non-steroidal anti-inflammatory drugs. "The appropriate use" of the Cox-2 drugs "should be influenced by the individual circumstance of each patient," the panel said.

The panel said Celebrex and Vioxx should be subject to stronger warnings given to patients, advertising that "prominently" discusses risks and detailed explanations of risks vs. benefits provided to doctors and pharmacists.

Health Canada said it would "immediately implement many" of the panel's recommendations "and we will work with our partners to see what further action can be taken."

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