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Serzone is the name brand of a tablet form of nefazodone, a prescription medication used to reduce the psychological and physical symptoms of depression, anxiety, and related disorders. Available in dosages of 50 mg, 100 mg, 150mg, 200mg, and 250mg, Serzone is manufactured by Bristol-Myers Squibb Company.

In 2001, worldwide sales of Serzone were $409 million. On May 19th, 2004 Bristol-Myers Squibb announced that due to declining sales, Serzone will no longer be sold in the U.S. after June 14th, 2004. Note that this action does not affect sales of generic versions of Serzone (nefazodone).

Side Effects of Serzone

The most common side effects reported with Serzone are sleepiness, dry mouth, nausea, dizziness, constipation, weakness, lightheadedness, problems with vision, and confusion.

If you experience any of the following symptoms while taking Serzone, however, call your doctor or healthcare professional immediately - yellowing of the skin or whites of the eyes (jaundice); loss of appetite that lasts for several days or longer; abdominal (lower stomach) pain; unusually dark urine; or nausea.

Patients who currently have liver problems or who were previously withdrawn from therapy with Serzone because of liver injury should not take Serzone. Also, you should not take Serzone if you are pregnant, plan to become pregnant or are breastfeeding a baby.

Serious Risks: Liver Damage

In December of 2001 the U.S. Food and Drug Administration (FDA) told Bristol-Myers Squibb Co. that it must include a "black box warning" on the label for Serzone, indicating that in rare cases people who take Serzone can develop serious (in some cases life-threatening) liver problems. The FDA orders a black box warning (referring to the requirement that the text of the warning be contained within a black-outlined box) only for those medications that present the most serious potential side effects.

The FDA issued a warning in March of 2002, cautioning the public that cases of life-threatening liver failure in patients taking Serzone had been reported. There were over 109 cases and, in at least 23 of them, the patients experienced liver failure. 16 other patients underwent liver transplants or died. The FDA estimates the rate of liver failure in patients who used the drug for at least one year is one in every 250,000 to 300,000. Liver failure rates are 3 - 4 times greater for Serzone users than non-users.

In March of 2003, the consumer group Public Citizen petitioned the FDA to ban Serzone from the U.S. market, based on the number of liver toxicity deaths purportedly related to the anti-depressant.

Serious Risks: Increased Depression and Suicidal Impulses

Antidepressant medications including Serzone have come under recent scrutiny from the FDA, for potentially increasing the severity of depression and tendency toward suicidal impulses in some patients. On March 22, 2004 the FDA asked manufacturers of a number of anti-depressants (including Serzone) to include in their product labeling a statement recommending close observation of adult and child users of the prescribed medication, for signs of increased depression and/or the emergence of suicidal impulses.

Serzone - Getting Legal Help

While almost all medications have some anticipated side effects, a drug manufacturer has a duty to adequately inform physicians regarding the known risks associated with its drugs. If a manufacturer fails to do so, it can be held responsible to patients who are injured as the result of inadequate warnings, under a legal theory known as "product liability".

If you or a loved one have taken Serzone and experienced any unusual side effects or suffered injury, you should contact a physician for proper medical attention. In addition, you should contact an experienced attorney, who will assess and protect your legal rights.

  • Go here to learn more about an attorney's role in a pharmaceutical liability case.
  • To find an experienced attorney, use the "Find a Lawyer" tool on this page, or click here.

See also:

  • Why Drugs Get Pulled from the Market
  • Pharmaceutical Product Liability
  • Next Steps
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