Canada May Allow Vioxx

An expert panel is recommending that Health Canada allow the controversial painkiller Vioxx back onto the market.

By a 12-1 vote, panel members concluded the benefits of Vioxx in providing pain relief outweigh the increased risk of heart attack and stroke. New Jersey-based Merck & Co. withdrew the drug from the worldwide market last September after a study showed it doubled patients risk of heart attacks and strokes.

Earlier this year, a panel of outside experts narrowly voted to recommend to the U.S. Food and Drug Administration to allow Vioxx back on the market.

Merck spokesman Guy Bizzoco said the company hadn't decided whether to reintroduce Vioxx in Canada and looked forward to discussing the issue with local officials. He added there are continued discussions with U.S. regulators about Vioxx's future.

The Canadian panel unanimously recommended that Celebrex continue to be sold but gave thumbs down to returning a third drug in the same class, Bextra, to the market. Celebrex and Bextra are made by Pfizer Inc.

Vioxx, Celebrex and Bextra, known as Cox-2 selective inhibitors, are prescription painkillers.

The panel concluded that these products pose similar risks to older drugs known as nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen.

In a surprise finding the panel suggested that ibuprofen, sold under the brand names Advil and Motrin, be kept behind the counter in pharmacies, and sold with new warnings about risks of cardiovascular disease.

Ibuprofen has been sold in Canada since the 1950s. Cox-2 inhibitors were introduced in the late 1990s.

Although ibuprofen is intended for short-term relief of pain and fever, the panel suggested that the drug is in reality being used chronically and at high doses.

It's now up to Health Canada to decide if it will accept the recommendations.

In June, the panel held public meetings at which patients, drug manufacturers and Health Canada officials discussed the risks and benefits of the drugs.

Currently Celebrex is the only Cox-2 inhibitor on the market in Canada. Pfizer suspended sales of Bextra due to concerns about a rare skin disorder as well as cardiovascular risks.

Merck shares fell 28 cents to $30.28 in afternoon trading on the New York Stock Exchange.