Vioxx alternative Celebrex faces uncertainty

Health Canada, the equivalent of Food & Drug Administration in the United States, has responded to new data about the cardiovascular risks of Celebrex by recommending to Canadian doctors that Celebrex should not be taken for the prevention of recurrence of Familial Adenomatous Polyposis and patients should discuss alternative therapeutic options with their doctors. Similar recommendation has been made by the FDA in the United States and it is widely expected that Celebrex will be either recalled by Pfizer under pressure from the FDA or FDA will ban the drug.

Health Canada also advises patients who are on long-term 400 mg daily doses of Celebrex to discuss alternative therapies with their physician. The agency has notified Pfizer that the market authorization for the use of Celebrex for the prevention of recurrence of Familial Adenomatous Polyposis has been withdrawn. Health Canada will shortly issue further advice concerning the safety of selective COX-2 inhibitor NSAIDs. The German authorities have already restricted prescription requirements for Cox-2 drugs.

The Australian Medical Association (AMA) president Bill Glasson, however, says there is no need to pull Celebrex from the Australian market, if doctors continue to prescribe it responsibly. Dr Glasson says that before making any decision to go off the drug, patients should remember that all medications have side-effects and taking them is a calculated risk. He is essentially repeating the statement of the Pfizer CEO Hank McKinnell who has been doing a round of interviews on television stations saying the same thing. He is admitting that Celebrex, like Vioxx, has adverse side effects but as long as patients are made aware of the risks there is no need to recall Celebrex. In that sense, he is taking an approach that is quite different from the one taken by Merck when it recalled Vioxx after it was reported that tens of thousands of people have been killed and countless others injured by Vioxx.

The Therapeutic Goods Administration, the Australian equivalent of the FDA, is, however, reviewing the new data about Cox-2 drugs. It is not yet known if Celebrex will be banned in Australia.

It will be interesting to watch what the FDA does about Celebrex since it is a blockbuster drug for Pfizer and has grabbed literally all the market share since the recall of Vioxx. Merck stock has taken a serious beating since the recall of Vioxx and similar fate awaits Pfizer if it voluntarily withdraws Celebrex or is forced to do so by the FDA.

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