FDA issues warning regarding effects on skin of alcoholism treatment Vivitrol

August 26, 2008

Washington - The Food and Drug Administration (FDA) has issued a physician warning regarding severe skin reactions in patients who have received Vivitrol, an injectable treatment for alcoholism, the Associated Press reports.

Washington — The Food and Drug Administration (FDA) has issued a physician regarding severe skin reactions in patients who have received Vivitrol, an injectable treatment for alcoholism, the Associated Press reports.

The FDA says physicians and patients should watch for swelling, infection and other skin complications at the point where the drug was injected. The agency stressed that doctors must use the proper needle to administer Vivitrol and inject it directly into the patient’s muscle rather than fatty tissue.

Vivitrol is manufactured by Alkermes and marketed by Cephalon, based in Frazer, Pa .

Nearly 200 reports of skin problems have been reported to the FDA by patients who have taken Vivitrol. According to the FDA’s Web site, 16 patients required surgery, ranging from draining puss to removing tissue.

The AP writes that a Cephalon spokesperson says some of the problems may be due to improper injection of the drug and thatwomen may be at higher risk because they often have thicker layers of fat than men.

The FDA says regulators are working with company officials on a stronger, more prominent warning label.

Vivitrol was approved in 2006 as a treatment for alcohol addiction, in tandem with counseling or group therapy.