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Canadian Health Advisory Panel Backs Return of Vioxx to Market

Merck withdrew the pain drug last year over concerns that it might increase the risk of developing heart disease.

July 08, 2005|From Reuters

TORONTO — The Canadian government said Thursday that Merck & Co. would have to reapply to market its arthritis drug Vioxx again, but it saw no reason not to approve the application.

Speaking after an advisory panel recommended allowing Vioxx back on the market, Marc Berthiaume, the director of the federal health department's marketed pharmaceuticals division, said any application would be judged on its own merits.

But he added, "There's no clear reason not to reintroduce it back on the market if there is a request by the manufacturer."

Merck withdrew the painkiller 10 months ago over reports that it increased the risk of heart disease.

A spokesman for Whitehouse Station, N.J.-based Merck would not say whether it had reapplied to market Vioxx in Canada.

"At this particular point, Merck has not made any decision whether to seek approval to bring back Vioxx, but we do look forward to discussions with Health Canada," he said.

Earlier, the Canadian health panel said Vioxx and Pfizer Inc.'s rival pain medicine, Celebrex, should be allowed to stay on the market. However, it recommended that Pfizer's Bextra be kept off the market.

The panel said the risk of heart disease from Vioxx was the same as that posed by similar painkillers, and that gastrointestinal harm appeared to be less.

Health Canada acknowledged the panel's findings and said that available data justified the marketing of Vioxx because the risk of cardiovascular incidents from the drug appeared to be similar to others in its class.

The panel met to study the risks of the three drugs, known as Cox-2 inhibitors, after reports of increased heart disease and stroke.

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

By a vote of 12 to 1, the Canadian health panel recommended that Vioxx be allowed back on the market. The lone dissenter said evidence suggested that the drug had a higher level of cardiovascular risk than Celebrex, especially at higher doses.

The panel was unanimous in recommending that Celebrex be allowed to stay on the market. However, the panel said both Celebrex and Vioxx should come with warnings about the risks associated with the drugs.

Cox-2 drugs were designed to be safer replacements for non-steroidal anti-inflammatory drugs, such as aspirin, ibuprofen and naproxen.

The panel voted against reintroducing Bextra, partly because of a lack of information and also because of the risk of a rare but serious skin disorder.

A U.S. advisory panel recommended in February that Vioxx and Celebrex be returned to the market. It also deemed Bextra safe. The Food and Drug Administration is waiting to see if Merck applies to sell Vioxx again.

On Thursday, shares of Pfizer eased 2 cents to $26.75 and Merck was down 58 cents at $29.98.

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