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Prescription Drug Alert - Serzone
January 10, 2002

The Office of Mental Retardation (OMR), through the Health Care Quality Units, has requested that PCPA circulate the following information on Serzone, a medication used for the treatment of depression.

SERZONE (NEFAZODONE) WARNING

Serzone (nefazodone) is a medication approved by the FDA for the treatment of depression.

On December 10, 2001, Bristol-Myers Squibb Co., manufacturer of Serzone, had been requested by the US Food and Drug Administration (FDA) to add a black-box warning on its label for Serzone addressing the rare but possibly life-threatening liver damage that can result in some people taking Serzone. Liver damage induced by Serzone can result in death or the need for liver transplant. It is estimated that about 1 person in 250,000 - 300,000 taking Serzone will experience liver failure.

According to a Bristol-Myers Squibb Co. representative, this side effect had always been listed in the information that addressed the use of Serzone. However, Bristol-Myers Squibb Co. is working with the FDA to promote increased awareness of this potential side effect by developing a black box warning notification that will be printed in the prescribing/detailing information.

Signs and Symptoms of liver damage

People taking Serzone should be aware of the signs and symptoms of liver dysfunction, which are:

  • Jaundice (turning yellow)
  • Lack of appetite
  • Gastrointestinal complaints (GI upset, nausea, vomiting, abdominal discomfort and or pain)
  • Malaise/lethargy.

If these symptoms occur, notify the your doctor immediately.

What to do if you are taking Serzone

  • Don't panic.
  • Don't stop taking your medication on your own.
  • Talk to your doctor about your personal risk of developing liver problems.
  • Be mindful of the signs and symptoms of liver dysfunction listed above.

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