Vioxx safe enough for Canadian market says health panel

Published on July 11, 2005 at 8:16 AM · No Comments

A canadian health advisory panel says that Merck's arthritis drug Vioxx should be allowed to go on sale again in the country, 10 months after the company withdrew the blockbuster painkiller over reports that it increased the risk of heart disease.

The panel considers that the risk of heart disease from Vioxx is the same as that posed by other, similar painkillers, and that gastrointestinal harm in fact appeared to be less.

They also recommended that Pfizer's rival drug Celebrex be allowed to stay on the market, but that Pfizer's other arthritis drug Bextra, be kept off the market.

In a meeting last month the panel examined the risks of the three drugs, known as COX-2 inhibitors, following reports of increased heart disease and stroke.

Drug company Merck voluntarily withdrew Vioxx from the market last September after the reports emerged, and Pfizer Canada suspended Bextra in April, but continued to sell Celebrex under restrictions.

The Canadian panel in a 12 to 1 vote, recommended that Merck's Vioxx be allowed back on the market.

The one dissenter on the panel said evidence suggested that Vioxx had a higher risk of cardiovascular harm than Celebrex, especially at higher doses.

Andreas Laupacis, the panel's chairman, says that the majority of the panel felt that Vioxx was clearly an effective anti-inflammatory drug, and that studies have shown that it is associated with less gastrointestinal toxicity than many of the traditional NSAIDs.

He says that though it clearly does increase the risk of heart disease, that is similar in magnitude to the other drugs, and it seems reasonable to recommend that it is returned to the market.

The report says that patients benefit from having a variety of drugs to choose from for pain relief, and the panel was unanimous in recommending that Celebrex be allowed to stay on the market.

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