Case Evaluation

Serzone: Serzone Side Effects

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Patients who currently have liver problems or who were previously withdrawn from therapy with Serzone because of liver injury should not take Serzone.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.

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