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May 19, 2004

Serzone Withdrawal Insufficient; Complete Ban Needed

Statement of Dr. Sidney Wolfe, Director, Public Citizen’s Health Research Group

Bristol-Myers Squibb (BMS) announced today that as of June 14, it will no longer ship its widely used antidepressant nefazodone (Serzone). Although stating this is being done for “business” reasons, this is questionable because   retail sales of Serzone topped $100 million in 2003.   Perhaps the real reason is      the liver toxicity of the drug, which has brought   massive litigation against the company.

There are two serious deficiencies in the action announced today by BMS: 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. 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. The U.S. Food and Drug Administration (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.

Public Citizen sued the FDA on March 15 over its failure to act on a petition we filed a year ago seeking a ban of nefazodone because it had been   linked to a mounting number of deaths and serious injuries from liver failure. That petition 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.

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 and Europe and is being taken off the market in Australia and New Zealand in May. 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.

Click here to view Public Citizen’s March 2003 and October 2003 petitions. Click here to view a copy of Public Citizen's lawsuit.



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