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FDA’s Failure to Act on Serzone is Illegal

March 15, 2004

FDA’s Failure to Act on Serzone is Illegal


Deaths and Injuries from Liver Toxicity Mount as Agency Tarries, Public Citizen Says in Lawsuit

WASHINGTON, D.C. – Public Citizen today sued the U.S. Food and Drug Administration (FDA) over its failure to act on a petition Public Citizen filed more than a year ago seeking a ban of the antidepressant drug nefazodone. The drug is marketed by Bristol-Myers Squibb as Serzone and has been linked to a mounting number of deaths and serious injuries from liver failure.

Public Citizen’s suit, filed today in the U.S. District Court for the District of Columbia, asks the court to find the FDA’s delay illegal and to require the agency to act. Serzone’s liver toxicity is a danger to public health, and the FDA’s slow decision process continues to put patients at risk of death or serious injury, the lawsuit says.

In March 2003, Public Citizen sought a ban on Serzone, citing 21 cases of liver failure and 11 deaths between 1994, when nefazodone was first marketed, and the spring of 2002. A supplemental petition, submitted to the FDA in October 2003, included an analysis of the FDA Adverse Event Reports Database. That analysis showed 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, but it is uniquely and unpredictably toxic.

“It is grossly negligent for the FDA to allow doctors to continue to prescribe and patients to continue to take Serzone,” said Sidney Wolfe, M.D., director of Public Citizen’s Health Research Group. “It’s a shame that we must sue to force the agency to fulfill its obligation to protect public health.”

Nefazodone has already been removed from the market in Canada and Europe and is scheduled to be 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. This strategy has clearly failed to curb the subsequent cases of liver failure and death caused by the drug, Public Citizen’s lawsuit said.

“The FDA has a legal responsibility to protect the public from unsafe drugs, and it is shirking that duty,” said Michael Kirkpatrick, an attorney with Public Citizen and the brief’s author. “Nefazodone is a danger and should be withdrawn now.”

During the past 30 years, Public Citizen has successfully petitioned for bans of 15 drugs and biologic agents, including Rezulin (for diabetes), Redux (for weight loss) and the dietary supplement ephedra.

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