Alcohol-Dependency Drug Causing Complications

Nearly 200 people treated with an injectable drug for alcohol dependence have suffered complications such as abscesses that required surgery to drain, the Food and Drug Administration said.

Vivitrol, made by Alkermes Inc. and marketed by Cephalon Inc., is an extended-release form of generic naltrexone that is used in patients being treated for alcohol dependence when the patients can abstain from drinking alcohol before receiving the drug therapy.

The FDA has received 196 reports of Vivitrol patients developing swelling, pain, bleeding, and other complications from the injections. Sixteen patients required surgery to drain the injection site or to repair damaged tissue, the FDA said.

Doctors are being advised to make sure they are properly administering Vivitrol injections and to closely monitor patients for swelling or other worsening reactions following treatment. Vivitrol may also result in side effects including nausea, headache, and diarrhea.

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