Serzone Withdrawal Possible in Canada

Bristol-Myers Squibb Discussing Serzone Side Effects and Safety with Health Canada

Bristol-Myers Squibb announced on August 29, 2003, that is is discussing Serzone side effects with Health Canada, citing concerns over Serzone and liver damage. The talks could result in the voluntary withdrawal of Serzone from the Canadian market.

Serzone already carries a black box warning on its label, cautioning doctors to watch for signs of liver damage. To date, four cases of liver failure have been reported in Canada and the US Food and Drug Administration has received reports of liver failure, in some cases severe enough to necessitate a liver transplant and some resulting in death

If Serzone is withdrawn from the Canadian market, the United States and Australia will be the only markets left for the drug. Bristol-Myers Squibb has voluntarily withdrawn Serzone from European markets.