Canada health panel says Vioxx pain drug safe enough

A Canadian expert advisory panel recommended on Thursday that Merck & Co. Inc.‘s arthritis drug Vioxx be allowed back on the market despite the possibility of cardiovascular risks.

The panel also recommended that Pfizer Inc.‘s rival pain medicine Celebrex be allowed to stay on the market but that Pfizer’s Bextra, another arthritis drug, be kept off the market.

The panel met at the government’s request last month to study the risks of the three drugs, known as COX-2 inhibitors, following reports of increased Heart disease and Stroke.

Merck voluntarily withdrew Vioxx from the market last September because of concern about such reports.

On April 7, Pfizer Canada announced the suspension of its Bextra, following the United States’ lead. It continued to sell Celebrex, but under restrictions.

The panel was unanimous on Thursday in recommending that Celebrex continue to be sold. It said the increased risk of cardiovascular disease was similar to that of other pain medicine while gastrointestinal harm appeared to be less.

“Patients benefit from having a variety of drugs to choose from for pain relief,” the report said.

By a vote of 12 to 1, the body recommended that Merck’s Vioxx be allowed back on the market, for the same reasons. The lone dissenter said evidence suggested that Vioxx had a higher risk of cardiovascular harm than Celebrex, especially at higher doses.

The vote was 8 to 5 against the reintroduction of Bextra, in part because there was not enough information available yet and because of a possible risk of a rare but serious skin disorder.

The panel recommended that warnings about the risks of Celebrex and Vioxx be added to the material given to patients.

Provided by ArmMed Media
Revision date: June 18, 2011
Last revised: by Jorge P. Ribeiro, MD