Serzone Injuries

May 2004: Serzone was pulled off the U.S. markets by its manufacturer, Bristol-Myers Squibb, citing diminished sales. Distribution of Serzone ceased on June 14, 2004.

Background:

Bristol-Myers Squibb insists that the decision to pull Serzone was based only on its decreased sales, however due to the many lawsuits over the drug's link to dozens of liver failure and liver toxicity; skeptics find this hard to believe.

Serzone, also known as nefazodone hydrochloride, is an antidepressant that fights mental depression by increasing natural substances in the brain. Serzone was approved by the FDA in December 1994. Since that time the FDA has requested, on at least eight separate occasions, that Bristol-Myers strengthen its warning on the drug. On December 7, 2001, the FDA required the company to add a black-box warning on Serzone, informing consumers about the increased risk of liver failure among patients who have taken the drug. A black-box warning is reserved for only the most serious side effects in medication.

In January 2002, Bristol-Myers Squibb 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 Serzone use is “about 3-4 times the estimated background rate of liver failure.” In Canada , Bristol-Myers sent a notice on June 20, 2001 informing doctors of reports of 109 “serious hepatic events” world-wide, including 23 cases of liver failure. That company letter indicated that 16 of the cases led to transplant or death.

A new warning has been added to Serzone prescribing information, advising 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.

What you can do:

If you or a family member have experienced a serious or fatal injury from the use of Serzone, you may want to consider your potential legal claim for this loss. If you would like legal counsel on this issue, click here to send an e-mail or contact us, toll free, at 1.800.755.0098 to be put in touch with an attorney at Zimmerman Reed for a consultation at no cost.