Federal authorities are warning physicians about adverse injection site reactions in patients receiving an injectable extended-release formulation of naltrexone for the treatment of alcohol dependence.
In issuing its August 12 warning, the US Food and Drug Administration (FDA) said it had received 196 reports of injection site reactions from the drug (Vivitrol, made by Alkermes Inc, Cambridge, Mass), including cellulitis, induration, hematoma, abscess, sterile abscess, and necrosis. The agency noted that 16 patients required surgical interventions ranging from incision and drainage to extensive surgical debridement of necrotic tissue.
Mitka M. Alcohol Dependence Drug Prompts Warning. JAMA. 2008;300(11):1289. doi:10.1001/jama.300.11.1289