Serzone is a brand of nefazodone, a medication used to treat depression. Nefazodone is in a class of medications called serotonin modulators. Nefazodone is chemically unrelated to the serotonin reuptake inhibitors (SSRIs), the tricyclic antidepressants (TCAs), or the monoamine oxidase (MAO) inhibitors. It is chemically related to another antidepressant, trazodone (Desyrel), and shares its actions. The FDA approved nefazodone in December 1994.
Serzone works by increasing the amounts of certain natural substances in the brain that are needed to maintain mental balance. Serzone comes as a tablet to take by mouth. It is usually taken two times a day with or without food.
Is Serzone Still On The Market?
No, the brand Serzone was taken off the U.S. market due to safety reasons as the drug was linked to several adverse events including liver failure. Before the withdrawal from the U.S. market, the drug had already been taken off the market in Europe, Australia, New Zealand, and Canada but the company continued to sell the drug in the U.S.
In a statement released by Bristol-Meyers spokesman, the company stated that “For commercial reasons, we’re discontinuing sales and manufacture of Serzone effective June 14, 2004. The company denies adverse events played any role in the withdrawal, even though the company acknowledged that was the case in the Canada withdrawal.
However, the watchdog group Public Citizen is suing the FDA to demand that all versions of the drug be taken off the market. Serzone and its generic equivalents unpredictably cause serious, sometimes fatal liver damage in a small number of patients. The drug must carry a “black box” warning on its label warning of life-threatening liver damage and recommending that doctors advise patients to be aware of liver problems. Short of an outright ban, that’s the FDA’s strongest health-risk message to consumers.
Nevertheless, generic brands of Serzone (nefazodone) are still on the market and have not been discontinued. Teva Pharmaceuticals, the sole manufacturer of Nefazodone stated that although material shortages are impacting the ability to make Nefazodone, the product continues to be available.
What are the possible side effects of Serzone (Nefazodone)?
Nefazodone may cause side effects. Call your doctor if any of these symptoms are severe or do not go away:
• constipation
• difficulty concentrating
• dry mouth
• flushing or feeling warm
• headache
• heartburn
• pain, burning, numbness, or tingling in the hands or feet
Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:
• blurred vision or vision changes
• confusion
• difficulty breathing or swallowing
• hives
• hoarseness
• itching
• memory problems
• painful erection of the penis lasting more than 4 hours
• rash
• seizures
• slow heartbeat
• swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs.
Nefazodone may cause other side effects. Call your doctor if you have any unusual problems while you are taking this medication. If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).
