Canada Panel Backs Vioxx Return

Merck says it hasn't decided what action to take on the move.
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A panel of medical advisers to Canada's health department on Thursday recommended that the

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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

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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.

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."