Serzone
Serzone, also known as nefazodone hydrochloride, belongs to a class of medications known as antidepressants. Manufactured by Bristol-Meyers Squibb Company, Serzone fights mental depression by increasing natural substances in the brain. The U.S. Food and Drug Administration approved Serzone in 1994.
Side effects of Serzone use include, but may not be limited to, blurry vision, skin rash or itching, lightheadedness, ringing in the ears, dry mouth, nausea and fatigue.
In December 2001, the FDA ordered Bristol-Meyers to include a so-called "black box warning" on Serzone's label. The new Serzone side effects label states that "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."
In January 2003, Bristol-Myers Squibb pulled Serzone from the European market because of its link to 25 reports of liver failure and 18 deaths.
Serzone has not undergone testing for efficacy and safety in children. Currently, no studies exist comparing use of Serzone in children up to 18 years of age with use in other age groups. The medication, however, has been prescribed to children despite a lack of evidence that the drug is safe. In fact, several patients, including children, have experienced liver failure as well as jaundice and hepatitis after taking Serzone. Many of these patients have required liver transplants in order to survive.
Researchers have linked concurrent use of Serzone and Zocor to the development of rhabdomyolysis. A March 2003 article, written by physicians at the University of Cincinnati College of Medicine and published in John Hopkins University's Advanced Studies in Medicine, discussed three recent cases of rhabdomyolysis in patients who had undergone concomitant use of Serzone and Zocor.
See your doctor if you have experienced serious side effects associated with Serzone. In addition, it may be important to contact an attorney who can help you protect your legal rights. Please keep in mind that there may be time limits within which you must commence suit.
