Bristol-Myers Squibb to Stop Sale of Dutonin in Europe

Despite Black Box Warning and Reported Deaths, Serzone Continues to Sell in U.S.

Bristol-Myers Squibb, the manufacturer of the antidepressant nefazodone, marketed as Serzone in the US and as Dutonin in Europe, announced January 8, 2003 that it will stop selling the drug in all European countries. The announcement follows reports of 26 cases of liver failure and some deaths. A Bristol-Myers Squibb spokesperson said the company will continue to sell Serzone in the US, despite increasing lawsuits involving Serzone because of its potential for severe effects on the liver or even fatal liver failure in patients taking Serzone.

In a statement issued by the UK Medicines Control Agency, it was reported that as of December 2002, there have been 26 reports of liver failure worldwide. Of those 26, there were 10 cases involving liver transplant and 13 deaths, including five in patients following liver transplant.

Bristol-Myers Squibb sent a letter to Doctors in Canada in June 2001 warning that Serzone can have fatal effects on the liver. Six months later, the US Food and Drug Administration ordered that a similar letter be sent to US doctors and a "black box warning" be added to the drug label, making patients aware of the potential harmful side effects of Serzone.

In early January 2003, Bristol-Myers' Dutch subsidiary announced that it will stop marketing Dutonin (Serzone/nefazodone) in the Netherlands in April 2003 after the Netherlands Medicine Assessment Board said it is investigating the antidepressant drug following reports of 26 cases of liver failure and some deaths due to Serzone worldwide. Bristol-Myers Squibb voluntarily withdrew Dutonin from the market in Sweden November 2002.