Serzone

Serzone® (nefazodone HCl) is used to treat depression. It is administered in tablet form, in dosages of 50 mg, 100 mg, 150 mg, 200 mg, and 250 mg. Serzone is manufactured by Bristol-Myers Squibb Co. Worldwide sales of Serzone were $409 million in 2001.

In December, 2001 the US Food and Drug Administration (FDA) told Bristol-Myers Squibb Co. that it had to include a "black box warning" on the label for Serzone, indicating that in rare cases people who take Serzone can develop serious liver problems.

Cases of life-threatening hepatic failure have been reported in patients treated with Serzone. The reported rate in the United States is about 1 case of liver failure resulting in death or transplant per 250,000 - 300,000 patient-years of Serzone treatment. The total patient-years is a summation of each patient's duration of exposure expressed in years. For example, 1 patient-year is equal to 2 patients each treated for 6 months, 3 patients each treated for 4 months, etc.

Patients should be advised to be alert for signs and symptoms of liver dysfunction (jaundice, anorexia, gastrointestinal complaints, malaise, etc.) and to report them to their doctor immediately if they occur.

Serzone should be discontinued if clinical signs or symptoms suggest liver failure.

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