Serzone Warning Information

Bristol-Myers Squibb Co. Advisory

The United States Food and Drug Administration recently notified Bristol-Myers Squibb Co. that it must include a black-box warning on the Serzone label advising patients that possibly life-threatening liver failure can occur with the use of the drug. The new label required by the FDA will include a warning as follows:

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.

Serzone is considered a viable alternative to other well-known antidepressants of the SSRI class, including Zoloft, Paxil, or Prozac.

In June 2002, Bristol-Myers sent a notice to doctors in Canada informing doctors of 109 serious hepatic events, including 23 cases of liver failure worldwide. Of those cases, 16 led to transplant or death. To view the letter in pdf format, click here.

We encourage you to find out more about your particular legal situation by taking advantage of the Free Serzone Case Evaluation service we offer on this site.