Vioxx safe enough for Canadian market says health panel

Jul 11 2005

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.

But the panel recommend that both Celebrex and Vioxx should carry warnings about the risks associated with taking the drug.

Originally COX-2 drugs were designed to be safer replacements for non-steroidal anti-inflammatory drugs, or NSAIDS, such as aspirin, ibuprofen and naprozen.

The vote against reintroducing Bextra, was in part due to a lack of information, and also because of the risk of a rare but serious skin disorder.

The panel also found, in their view, that data to show that adding aspirin to COX-2 drugs protects against cardiovascular disease, was unconvincing.

According to Laupacis the report has been handed to Health Canada, but he has no indication whether the agency will follow its recommendations.

In February a U.S. advisory panel recommended that Vioxx and Celebrex be returned to the market, and it also declared Bextra to be safe.

To date Merck has not decided whether to put Vioxx back on the market, in Canada or elsewhere.

Drug company Pfizer has yet to comment.