August 14, 2008
Alcoholism Drug May Cause Skin Reactions, Warns FDA
FDA officials have issued warnings on an injectible treatment for alcohol dependence which might lead to severe skin reaction in patients. The drug called Vivitrol is manufactured Alkermes Inc and marketed by Cephalon Inc.
On Tuesday, federal regulators asked doctors and patients to look out for skin complications like swelling or infections at the point where the drug has been injected. The authorities also insisted that physicians use the correct needle for the injection which should moreover be administered directly into the muscle and not into the fatty tissue of the patient.
The FDA looked into the matter after receiving almost two hundred reports of skin complaints from patients who had been injected with Vivitrol as part of treatment for alcohol addiction. As many as sixteen patients have had to go for surgery for reasons ranging from pus drainage to tissue removal. According to a notice posted at the FDA website, patients whose skin condition does not improve within two weeks should go for a surgical consultation.
Vivitrol has been in the market since 2006 when it was approved for the treatment of alcohol dependence together with group therapy and personal counseling. It main competitors in the market are Campral from Forest Laboratories as well as other generic variations.
-Kalyani Mookherji
















