Nearly 200 reports of adverse events have been reported by patients following injections of Vivitrol, an alcohol dependence drug made by Alkermes Inc., the Food and Drug Administration announced on Tuesday.
Among the complications reported are pain, swelling, and bleeding. Some patients developed abscesses that required surgical removal.
Vivitrol Injections Require Precision
Vivitrol gained FDA approval in 2006 for the treatment of alcohol dependence in patients able to stop drinking prior to receiving the drug. It is administered once a month by injection into the gluteal muscles, and as many as 70,000 patients have received injections of Vivitrol since its approval.
According to the FDA, complications seem to result when the drug is injected into the fat layer above the muscle rather than the muscle itself. The agency has asked doctors to ensure the injection needle reaches the muscle, and patients are advised to monitor the injection area for any adverse reactions.
Other side effects associated with Vivitrol include headaches, nausea, diarrhea and liver damage.