In a surprising move, Canadian health authorities are moving towards approving the resumption of Vioxx sales. The prescription pain killer was removed from the market in September 2004 over concerns of heightened risks of heart attacks and strokes among those who have taken it for extended periods.
But an advisory panel to Health Canada, the Canadian counterpart to the U.S. Food and Drug Administration, said the risk of heart disease from Vioxx appears to be the same as that posed by other similar painkillers, and that gastrointestinal risks appear to be less.
The advisory group also recommended that Celebrex, a COX-2 drug made by Pfizer, Inc., be allowed to remain on the market, but that Pfizer's Bextra, another arthritis drug, be kept off the market.
"We welcome the panel's report and I'd like to thank the public for its contribution," Canadian Health Minister Ujjal Dosanjh said. "This is the first time that the Canadian public has been invited to participate in a Health Canada expert advisory panel. Health Canada supports the direction of the Panel's recommendations."
Health Canada said it will immediately implement many of the panel's recommendations and will work with its partners to see what further action should be taken.
The agency said it acknowledges the panel's view that, as a group, selective COX-2 inhibitors are associated with an increased risk of cardiovascular events, a risk that is similar to those associated with most non-steroidal anti-inflammatory drugs (NSAIDs), a category that includes other COX-2 drugs as well as ibuprofen and other popular pain relievers. The panel noted that this risk is present for all patients taking anti-inflammatory agents and that it increases with longer-term use and when other risk factors, such as cardiovascular disease, are present.
In the case of Vioxx, which is not currently authorized for sale in Canada, the panel reported that available data justifies the marketing of Vioxx in Canada because the risk of cardiovascular incidents from Vioxx appears to be similar to that of most NSAIDs. In order for VIOXX to be marketed in Canada, the manufacturer is required to submit a new drug submission to Health Canada. The submission would be reviewed to ensure it meets safety data requirements, with particular attention to the safe labeling issues raised by the panel.
The panel, which met June 9-10, 2005 in Ottawa, was created by Health Canada to provide input and advice on the safety of COX-2 NSAIDs and was one part of an extensive review and study of research related to the safety of these drugs.
Merck Pharmaceuticals, the maker of Vioxx, had no immediate comment on its Website about the Health Canada recommendation. In the U.S., the FDA continues to study the risks associated with COX-2 drugs.
