FDAnews Drug Daily Bulletin


July 12, 2005

A panel of Canadian health experts has recommended the return to the market of Merck's arthritis pain drug Vioxx - a potential move that could help the firm in its legal battles over the withdrawn drug, according to an analyst.

In a 12-1 vote, advisers to Health Canada agreed the overall benefits of Vioxx (rofecoxib) outweighed the risks. The available information justifies marketing Vioxx in Canada, said the panel, which met in June to examine the safety profile of Vioxx and other Cox-2 nonsteroidal anti-inflammatory drugs (NSAIDs), including Pfizer's products Celebrex (celecoxib) and Bextra (valdecoxib).

No additional studies of Vioxx are mandatory before the drug is marketed again, according to the panel's recommendations. The panel also unanimously agreed Celebrex should remain on the market, but voted 8-5 against the return of Bextra, which was voluntarily withdrawn this spring over concerns that it can cause severe adverse skin reactions. Merck pulled Vioxx in September 2004 after studies found the drug increased cardiovascular risks.

All three drugs are effective anti-inflammatory agents, and are associated with a decrease in the frequency of both gastrointestinal intolerance and peptic ulcer disease compared with NSAIDS, the panel said. At the same time, all three increase the frequency of hypertension, edema, renal disease and clinically important cardiovascular events, which seem similar in magnitude to those associated with NSAIDs, the advisers added.

The Canadian recommendations generally mirror those of the FDA's Drug Safety and Risk Management and Arthritis Advisory Committees, which met in February to discuss the products. In a 17-15 vote, the FDA advisers agreed Vioxx's overall risk-benefit profile supports marketing the product in the U.S., but only with strict restrictions and warnings. The FDA concluded in April the increased risk of cardiovascular events is a class-wide problem affecting all NSAIDs, and the agency called for the withdrawal of Bextra based on its link to life-threatening skin reactions.