Additional adverse reactions for Vivitrol

VIVITROL (naltrexone) 380mg/vial for injection by Alkermes
VIVITROL (naltrexone) 380mg/vial for injection by Alkermes

The FDA has received reports of adverse injection site reactions in patients receiving Vivitrol (naltrexone extended-release injectable IM suspension, from Cephalon). Reported reactions include cellulitis, induration, hematoma, abscess, sterile abscess, and necrosis. Risk of serious reactions may be increased if Vivitrol is deposited in subcutaneous or fatty tissue. Vivitrol should only be administered IM with its pre-packaged needle to avoid improper injection.

Vivitrol is an opioid antagonist indicated for the treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting in conjunction with psychosocial support.

For more information call (800) 848-4876 or visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm106211.htm.