Health Canada, the country’s drug regulatory body, yesterday followed the advice of its expert advisors and said it would be open to the re-marketing of Merck & Co’s withdrawn COX-2 inhibitor Vioxx (rofecoxib) [[01/10/04a]].
Merck pulled Vioxx from the market last year after a study showed it doubled the risk of heart attack and strokes amongst patients taking the drug for more than 18 months. The move was swiftly followed by the global withdrawal of Pfizer’s Bextra (valdecoxib) because of concerns over a rare, but potentially fatal, skin disorder [[08/04/05a]]. Amongst the big three COX-2s in what was a multi-billion dollar market, only Pfizer’s Celebrex (celecoxib) remains available.
Meeting this week, a Health Canada panel concluded that – while the use of COX-2 specific painkillers is linked to an increased risk of cardiovascular events – the risk is no greater than with use of traditional non-steroidal anti-inflammatory drugs (which have an effect on both the COX-1 and COX-2 systems). Based on this observation, the fact the risk of harm to the gut appears lessened, and that patients benefit from having a variety of painkillers to choose from, the panel voted 12-1 that Vioxx be allowed on to the market. In order for Vioxx to be marketed in Canada, Merck will be required to submit a regulatory dossier for approval – a decision that the US giant has yet to make public.
However, the news was not so good for Pfizer, as the door was firmly closed on its offering Bextra. The committee voted eight to five that Bextra not be allowed back onto the market because of a lack of information about its cardiovascular risk, the link to a potentially serious skin disorder and the availability of numerous other non-steroidal anti-inflammatory agents with more complete risk:benefit analyses.
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. Openness and transparency will become a way of doing business in the Department.”