Medication guide required by FDA for Vivitrol

The FDA and Alkermes have notified healthcare professionals and patients of an update to the Warnings, Information for Patients, and Dosage and Administration sections of the Vivitrol (naltrexone injection) Prescribing Information to strengthen language regarding the risk of injection site reactions based on postmarketing reports that had been received prior to June 2009. Alkermes has developed a Medication Guide to replace the Patient Package Insert for Vivitrol to communicate this and other important information. The FDA requires that the Medication Guide be provided to all patients.

Vivitrol is 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 (eg, counseling or group therapy).

For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm210755.htm.