Public Citizen to sue FDA over Serzone

Noting that the US Food and Drug Administration had failed to act on a petition filed in March 2003 to ban Bristol-Myers Squibb's Serzone (nefazodone), Consumer advocacy group Public Citizen is now suing the agency and asking the court to find the FDA's failure to act on the petition illegal. It also asks that the agency be ordered to make a decision on its petition.

The antidepressant, which has been linked to life-threatening liver damage, has already been taken off the market in Europe and Canada and is set to be withdrawn in Australia and New Zealand in May.

Citing reports in the FDA database of 55 cases of liver failure in Serzone users, including 20 deaths, Sidney Wolfe, head of PC's Health Research Group, called the agency negligent for allowing doctors to continue to prescribe, and patients continue to take, Serzone. The group also said that the number of incidents is likely to be higher because they are usually under-reported. Since January 2002, Serzone's label has included a black-box warning that it may cause life-threatening liver damage.