Health advocacy group calls for drug recall

Even though drug maker Bristol-Myers Squibb (BMS) announced that it will no longer ship its widely used antidepressant nefazodone (Serzone), the action doesn’t go far enough to satisfy many health care advocates. The drug has been linked to an increasing number of deaths and serious injuries from liver failure.

A petition filed with the U.S. Food and Drug Administration (FDA) by Public Citizen in 2002 cited 21 cases of liver failure and 11 deaths between 1994, when nefazodone was first marketed, and spring 2002. A supplemental petition, submitted to the FDA in October 2003, said that from April 1, 2002, through May 12, 2003, there were 33 additional reports of liver failure, including nine deaths, for a total of 55 patients with liver failure, including 20 deaths.

Few observers believe BMS’ claim that it stopped shipping the drug for “business” reasons, as retail sales of Serzone topped $100 million in 2003. A more likely motive was the massive litigation against the company by those who say they suffered liver toxicity due to the drug.

Public Citizen was quick to point out that there were two serious deficiencies in the BMS action.

First, because the company is not ordering a recall of the drug and will merely stop shipping after June 14, patients will be able to fill (or refill) prescriptions for many more months because the drug will still be available in channels of commerce including wholesalers and retail pharmacies. “The failure to order a recall is irresponsible,” said Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group. “BMS should immediately send letters to all doctors to facilitate the change to any of a variety of other safer, equally effective antidepressants.”

Second, although BMS’s Serzone has sold by far the largest share of nefazodone, generic versions are now available. Wolfe argued that the FDA “must force those companies to remove their drugs from the market. Otherwise, the cases of liver failure, liver transplant and death will continue with the generic versions of nefazodone. We strongly urge all people using either Serzone or generic nefazodone to contact their physicians about switching to a safer antidepressant.”

The liver toxicity dangers of nefazodone are compounded by the fact that it inhibits a key enzyme that is involved in the metabolism of about half of all prescribed drugs, including itself, so nefazodone increases the toxicity dangers of other drugs a patient may be taking. Also, by inhibiting this enzyme, nefazodone can increase its own concentration, with potentially toxic results.

Serzone has not been shown to be more effective in controlling depression than other drugs in its class. Nefazodone has already been removed from the market in Canada, Europe, Australia and New Zealand. Since January 2002, a “black box” warning has been included in its U.S. packing insert, warning of life-threatening liver damage and recommending that physicians advise patients to be aware of signs of liver problems.

SOURCE: “Serzone Withdrawal Insufficient; Complete Ban Needed,” Statement of Dr. Sidney Wolfe, Director, Public Citizen’s Health Research Group, May 19, 2004.