FDA Warns Of The Skin Reactions Caused By Alkemes’ Alcoholism Drug
Submitted by Carina Rose on Wed, 08/13/2008 - 10:19
A drug to treat alcoholism, developed by Alkermes Inc. and marketed by Cephalon Inc., has reportedly caused blood clots, swelling, abscesses, cell death and other undesirable reactions in nearly 200 cases, according to a warning for health-care professionals circulated on Tuesday by the Food and Drug Administration.
The FDA has posted warning on its website stating 196 reports of injection site reactions from the drug Vivitrol including cellulitis, blood clots, abscesses, and necrosis (cell death).
16 patients, out of these reports, needed surgery to facilitate their treatment varying from draining puss to removing tissue.
Cephalon spokeswoman Candace Steele said the Frazer, Pa.-based company is of opinion that some of the problems resulted from inappropriate injection of the drug. She added that women may be more susceptible to such problems because they often have thicker layers of fat than men.
Steele said that the risks of skin reactions are already mentioned in the product’s label. She said, “We are committed to working with FDA to make sure physicians understand this information.”
Shares of Cambridge, Mass.-based Alkermes fell 44 cents to close at $16.45 Tuesday, while Cephalon shares added 4 cents to close at $76.92.
