Serzone, by Bristol-Myers Squibb Co. is a drug that is used by some physicians to treat depression. Serzone, also known as nefazodone hydrochloride, was put on the U.S. market with no warnings whatsoever regarding potential liver damage even though pre-clinical trials showed that there was the possibility of liver damage to humans. After Serzone was introduced, the Food and Drug Administration (FDA) required the manufacturer to place a warning on the drug's label. That warning, for the first time, warned of "rare reports of liver necrosis and liver failure, in some cases leading to liver transplantation and/or death." Within six months, the government forced the manufacture to remove the word "rare" from their warning on the label and to put a "Black Box Warning" on the drug.

The new label required by the FDA includes the following:
Cases of life-threatening hepatic failure have been reported in patients treated with SERZONE. . . . This represents a rate of about 3-4 times the estimated background rate of liver failure. This rate is an underestimate because of under reporting, and the true risk could be considerably greater than this.

It was only after the government's forced Black Box Warning that Bristol-Myers Squibb told physicians and other health care providers that Serzone could cause liver failure and death. According to the manufacturer and the government, the side effects of Serzone include jaundice (yellowing of the skin and eyes), dark colored urine, loss of appetite, abdominal pain, and physical discomfort or uneasiness.

Serzone is administered in tablet form, in dosages of 50 mg, 100 mg, 150 mg, 200 mg, and 250 mg. Sales of Serzone were $409 million worldwide in 2001. Other common Serzone side effects include headache, constipation, dry mouth, drowsiness, insomnia, nausea, vision problems, agitation, dizziness, fatigue, confusion, hypotension, rash or hives, seizures, and lightheadedness. In a study performed on Serzone prior to the marketing of the drug found 16% of the 3,496 patients taking Serzone discontinued their use due to side effects.

Serzone, once considered to be an alternative to other SSRI antidepressant drugs, has been withdrawn voluntarily by the manufacturer from all countries except Australia and the United States. Australians are warned of the potential for severe liver injury from using Serzone and in the US, Serzone carries a black box warning advising patients that possibly life-threatening liver failure can occur with the use of the drug. The drug, sold under the name Serzone by Bristol-Myers Squibb is known generically nefazodone.

Serzone to be withdrawn from US market

On May 19, 2004, the company announced that it would withdraw Serzone from the US market next month, blaming a decline in sales rather than the risks of liver damage.

Several lawsuits are pending against both Bristol-Myers Squibb and the U.S. Food and Drug Administration (FDA). Serzone will remain available as a generic medication (Nefazodone), and attorneys report that they will continue their suits against the FDA until the drug is banned from the market entirely.

The reported rate of liver failure in the United States is about 1 case resulting in death or transplant per 250,000 - 300,000 patient-years of Serzone treatment. The dozens of deaths resulting from Serzone use has prompted Serzone lawsuits to be filed by family members. Serzone deaths continue despite the black box warnings because it's impossible to tell which patients will get liver damage from Serzone. While a given patient has a very low risk of liver failure, those who do get liver failure may not see any warning signs until it's too late.

Serzone class action lawsuit

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