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Serzone Depression Medication Users v Bristol-Myers Squibb Company, Inc.

Case Category Amount Available Date Filed Stage
Drugs / Medical No amount specified 12/22/2000 Response  
 
Depression Drug Can Damage Liver
 
A class action has been brought against Bristol-Myers Squibb Company, Inc., the maker of the prescription antidepressant Serzone (nefazodone hydrochloride), to recover for liver damage and other injuries suffered by patients taking this drug.The action alleges that the manufacturer either knew or should have known that Serzone is associated with liver failure and other life-threatening complications. Accordingly, the action asserts that the drug is unreasonably dangerous. The action asks the court to order the manufacturer to provide medical monitoring to patients who have taken Serzone to watch them for signs of liver damage and other complications.

According to the Los Angeles Times, eighteen cases of liver failure involving Serzone patients were reported to the federal Food and Drug Administration (FDA) from 1996 to June 2000. Several cases have been described in the medical literature. The FDA approved Serzone in December, 1994. Finally, on January 9, 2002, the FDA ordered a "Black Box" warning to be placed on Serzone packaging due to the liver injuries that have been reported.

In an article titled 'Nefazodone-induced liver failure: report of three cases,' a group of Cincinnati, Ohio physicians reported that three women, 16 to 57 years old, who were taking Serzone developed severe liver damage. Two of the women needed a liver transplant; the third was listed for transplantation but subsequently improved. The women had been taking Serzone for 14 to 28 weeks before the onset of symptoms. The physicians concluded that Serzone is unpredictable in terms of when it can cause liver damage.

One of these three patients, Alissa Robinson, who was only 15 when Serzone was first prescribed for her, has been profiled in an investigative report in the Los Angeles Times. She almost died, had a liver transplant, and now faces a lifetime of uncertain health and worry over how she will pay for her medical care. The newspaper's story reported that, when Serzone was approved, the Food and Drug Administration knew that it had not been shown to be safe for use in children and adolescents. While the manufacturer promised to research the effect of Serzone use on younger patients and to report the results to the FDA, no such results have been provided. The company now says it hopes to report results to the FDA 'in the early part of 2002.'

In a case report titled 'Reversible Nefazodone-induced liver failure,' physicians at the Medical University of South Carolina described a 46-year-old woman who came to the medical clinic with a 2-month history of fatigue. A liver biopsy revealed 'ballooning degeneration and necrosis of hepatocytes in zone III, as well as extensive mixed inflammatory cell infiltrates, with occasional eosinophils.' Four months after stopping Serzone, the woman's liver function tests had returned to normal. The physicians concluded that the woman's 'severe hepatocellular jaundice' was attributable to the Serzone.

In clinical trials before Serzone was approved, several other side-effects were noticed: dry mouth (25%), drowsiness (25%), nausea (22%), dizziness (17%), constipation (14%), weakness (11%), lightheadedness (10%), blurred vision (9%), confusion (7%) and abnormal vision (7%). [The percentages represent the frequency of the occurrence of a particular side effect in the trials.] Serzone also may cause a mood swing called hypomania. Symptoms of hypomania include euphoria, racing thoughts, pressured speech, and excessive energy.



 

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