FDA Requires Printed Warnings for Vivitrol

WASHINGTON, May 4 (UPI) — The U.S. Food and Drug Administration says it is going to require a printed medication guide be given to patients using Vivitrol injectable suspension.

The FDA said it will require a medication guide detailing the risk of injection site reactions, as well as other information, be given to Vivitrol patients.


Officials said Vivitrol (naltrexone ) is an extended release, injectable suspension indicated for the treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting.

The FDA said the medication guide provides information patients should know about Vivitrol, including side effects, who should not take the medication, what patients should tell their healthcare professional before starting Vivitrol. Among other things, patients are warned they might not feel the usual effects of opioid-containing medicines, including medicines for pain, cough and diarrhea, while using the drug.

Vivitrol is manufactured by Alkermes Inc. of Waltham, Mass.

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