[Skip to Content]
Access to paid content on this site is currently suspended due to excessive activity being detected from your IP address Please contact the publisher to request reinstatement.
[Skip to Content Landing]
Citations 0
Medical News & Perspectives
September 17, 2008

Alcohol Dependence Drug Prompts Warning

JAMA. 2008;300(11):1289. doi:10.1001/jama.300.11.1289

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.