FDA Warns of Vivitrol Skin Reactions

The FDA has issued an alert to healthcare professionals about the risk of adverse skin reactions for individuals who receive an injection of Vivitrol, a drug given to treat alcohol dependence.

According to information posted on the FDA website on Tuesday, the agency has received 196 reports of Vivitrol skin reactions in patients treated with anti-alcohol injection, including abscesses, cellulitis, pain, swelling, tenderness, redness, bruising, bleeding and necrosis. In addition, 16 of the reports involved surgical treatments, such as incision and drainage for abscesses (fluid-filled cavities) and removal of dead tissue (necrosis).

Vivitrol (naltrexone) is manufactured by Alkermes Inc. and marketed by Cephalon Inc. In April 2006, the FDA approved the drug for treatment of alcohol dependence in outpatients who can abstain from drinking prior to initiation of therapy. It is the market name of extended release injectable suspension formulation of naltrexone. It is given by a healthcare provider as part of a comprehensive therapy for alcoholism, including group therapy or counseling along with medication. Annual sales of the drug are over $450 million.

By binding to opioid receptors in the brain, Vivitrol dampens the desire for alcohol and may reduce the sensation of pleasure a person gets from drinking alcohol. The non-addictive drug has been shown to reduce the number of drinking days in a month for alcoholics and the number of heavy drinking days.

Vivitrol is administered as an intramuscular gluteal injection once a month in a 380 mg dose and is released into the body at a controlled rate. The FDA warned that the drug should not be injected subcutaneously, intravenously or into fatty tissue, as this increases the risk of tissue damage. Healthcare providers have also been urged to use a special 1 ½” needle supplied with the drug for injection and to make sure they inject the drug properly at the correct dosage.

The FDA has also asked physicians to instruct patients to monitor Vivitrol injection sites for reactions, such as redness, pain, swelling, itching and bruising. If symptoms persist or worsen within two weeks, they should be referred to a surgeon. Tissue damage may result in fluid-filled cavities (known as an abscess) or death of the tissue (known as necrosis). Women are more at risk of Vivitrol skin reactions, because they have a larger amount of gluteal fatty tissue.