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Serzone, a drug used to treat anxiety and depression, became available in 1994, but after reports of liver failure resulting in transplants or death, manufacturer Bristol-Myers Squibb pulled it off the market a decade later.

Background

By December 2001, the FDA received more than 100 reports of liver damage associated with the drug generically known as nefazodone hydrochloride. Out of these cases, 20 resulted in death.

Patients taking Serzone experienced such symptoms as:

  • Yellowing of the skin or whites of eyes
  • Having extremely dark urine
  • Loss of appetite for several days
  • Nausea and lower stomach pain
  • Malaise

Along with these, patients may have further had hives or a rash, seizures, dizziness or fainting, constipation, fever, or headaches.

Because of the reports, the FDA issued a warning. Bristol-Myers Squibb, as a result, had to add a black box label warning to all drugs.

However, less than three years later, Public Citizen sued the FDA, alleging gross negligence for not banning Serzone after 55 instances of liver failure. Two months after this occurrence, Bristol-Myers Squibb decided to stop manufacturing Serzone, citing low demand.

Serzone continues to be available under its generic name in varying strengths, labeled as “nefazodone hydrochloride” or “nefazodone HCl” and no longer manufactured by Bristol-Myers Squibb.

Lawsuits

Since Public Citizen’s initial claim, more plaintiffs have come forward, alleging that the FDA bears a responsibility in getting the generic medication off the market. Further, lawsuits allege Bristol-Myers Squibb knew of the risks as far back as 1994 but continued to manufacture and market the drug.

Several cases were consolidated into multi-district litigation in 2004 at the state level. Although 6,524 plaintiffs were initially involved, 2,536 eventually opted out. In 2005, Bristol-Myers Squibb reached a $70 million settlement in the U.S. District Court for the Southern District of West Virginia.

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