Canada Panel Backs Vioxx Return

A panel of medical advisers to Canada's health department on Thursday recommended that the Merck(MRK) arthritis drug Vioxx be returned to the market.

Merck withdrew Vioxx from all markets Sept. 30 after noting that clinical tests showed that patients taking the drug for more than 18 months had an increased risk of cardiovascular problems.

The panel's recommendation by a vote of 12-1 will be reviewed by the health department, Health Canada. If Merck wants to sell Vioxx again in Canada, it must submit a new application, Health Canada said Thursday.

The department said its review would pay close attention "to the safe labeling issued raised by the panel."

A Merck spokesman said Thursday that his company hasn't decided whether to bring Vioxx back to the Canadian market or any other market. Merck will discuss the matter with Health Canada, and it is continuing its discussions with the Food and Drug Administration, he said.

The Canadian advisory panel also voted unanimously that Celebrex, a Pfizer(PFE) arthritis drug, continue to be marketed.

However, it voted 8 to 5 against another Pfizer arthritis drug, Bextra, being allowed back on the market because "there was not sufficient information available about cardiovascular risk." The majority also opposed Bextra because of the risk of a rare but potentially dangerous skin disorder associated with the drug. The Bextra supporters on the panel said the drug should be allowed on the market as a pain reliever for patients for whom other medications had failed.

Pfizer suspended sales of Bextra and in the U.S. and foreign markets in April after the FDA said "the overall risk vs. benefit profile for the drug is unfavorable." Pfizer said it disagreed with the FDA, adding that it would discuss with regulators the circumstances for which Bextra might return to the market.