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, and is manufactured by Bristol-Myers Squibb Co. Worldwide sales of Serzone were $409 million in 2001.

On December 7, 2001, the Food and Drug Administration informed Bristol-Meyers Squib Co. that it must include a "black-box" warning on the labels of Serzone. This warning came after it was learned that Serzone was responsible for life-threatening liver failures that led to death or the necessity of a liver transplant. A black-box designation is reserved for only the most serious side effects in medications.

On January 9, 2002, Bristol-Myers Squib issued a manufacturer's warning advising health care providers that "cases of life-threatening liver failure have been reported in patients treated with Serzone" and that the rate of liver failure associated with its use is "about 3-4 times the estimated background rate of liver failure." FDA psychopharmacology team leader Thomas Laughren, commented on the liver failure reports with Serzone patients, "We believe that it's drug-related and that this drug is different from the others in the class."

A new warning has being added to Serzone prescribing information, recommending that "patients should be advised to be alert for signs and symptoms of liver dysfunction, such as jaundice, dark colored urine, loss of appetite, nausea, gastrointestinal complaints and malaise, and to report them to their doctors immediately should they occur." Cases involving liver failures were reported after 2 weeks to 6 months of Serzone therapy.

It is strongly advised that anyone who has taken Serzone in the past, or is currently taking Serzone, should contact a health care professional for further information. If you or someone you know has experienced a serious or fatal injury from the use of Serzone, you may have a valid legal claim for this loss.