By Susan Heavey
WASHINGTON (Reuters) - Nearly 200 patients given Alkermes Inc's drug Vivitrol for alcohol dependence reported complications from the injection, including abscesses requiring surgical drainage, U.S. health regulators said on Tuesday.
Vivitrol, an extended-release version of the generic drug naltrexone marketed by Cephalon Inc, was approved in 2006 to treat alcohol dependence in patients who show they can abstain from drinking prior to receiving the drug therapy.
Since then, the Food and Drug Administration said it received 196 reports of patients who were given Vivitrol and developed swelling, pain, bleeding and other complications. Sixteen required surgery to drain the injection site or to repair damaged tissue, the FDA said.
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