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Serzone, the brand name for nefazodone, has been lined to Serzone liver failure leading to death in some instances. First approved in the U.S. in December 1994 as an antidepressant, Bristol Myers Squibb reported it was being taken off the market in May 2004. Though the drug was already taken off the market in Europe, Australia, New Zealand and Canada for adverse events including Serzone liver failure, which Bristol Myers acknowledged in the case of the Canadian removal, Serzone was still available for sales in the U.S.

The drug was, and still is, controversial for the Serzone liver effects that caused irreversible liver damage and death, according to patients and surviving family members. The FDA forced Bristol Myers to add Serzone liver warnings in a “black box” warning, the FDA strictest drug warning short of a drug recall, in January 2002, but the move was insufficient, according to the Public Citizen consumer group.

In March 2003, the Public Citizen petitioned the FDA seeking the immediate ban of Serzone because of the liver effects linked to a growing number of deaths and serious injuries. According to critics, the Serzone liver warning included on drug labeling was not sufficient enough considering the drug’s potentially deadly risks and ineffectiveness in controlling depression compared to other drugs in its class.

When the FDA failed to act on its petition, Public Citizen sued the agency in March 2004 because of the group’s concerns with the mounting number of deaths and serious injuries from Serzone liver failure. When Bristol Myers announced it was discontinuing the sales and manufacture of Serzone in May 2004, the company said it was because of “commercial reasons” and denied adverse events playing any role in the company’s decision, even though it acknowledged Serzone liver events were the cause of the Canadian withdrawal.

Reports of a total of 55 patients with Serzone liver failure, including at least 21 deaths had been made in the U.S. up to that point, without the high percentage of adverse event reports that are estimated to go unreported. Hundreds of lawsuits were immediately filed against Bristol Myers, alleging Serzone liver effects and other adverse events were caused because of the drug. The only reason Public Citizen said the drug remained on the market was to make money for Bristol Myers.

Public Citizen issued a statement finding the Serzone withdrawal insufficient because the company did not order a recall of the drug but was merely stopping shipping after June 14, 2004, and the FDA was allowing generic versions of Serzone to remain on the market. The FDA later determined, after independently evaluating “relevant literature and data, including from FDA’s Adverse Event Reporting System,” that the voluntary withdrawal of Serzone was not for reasons of safety or effectiveness, creating further controversy because it allowed generic versions of Serzone to remain on the market and the possibility for additional generics to be approved in the future.

The controversial antidepressant is still involved in litigation for Serzone liver failure and other adverse effects. Public Citizen issued warnings to consumers about Serzone liver dangers more than two years before its eventual removal from the market, although Bristol Myers has continued to stand by stating it was done for “business” reasons.

"Bristol-Meyers Discontinues Serzone"

Drug manufacturer Bristol-Meyers announced Wednesday that it will no longer make or sell Serzone, an antidepressant that has been linked to potentially deadly liver complications and has already been withdrawn in major markets including Europe and Can...

» Read More

"FDA Sued Over Failure to Act on Petition for a Serzone Recall"

Public Citizen has sued the FDA, calling the agency "grossly negligent" for failing to issue a Serzone ban despite having already been taken off the market in Canada and Europe, with sales to end in Australia and New Zealand in May. The consumer watchd...

» Read More

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