The FDA posted a warning letter to Alkermes plc regarding opioid dependence drug Vivitrol (extended-release naltrexone), stating the Dublin-based company omitted warnings about the most serious risks associated with the drug from promotional materials. Specifically, the letter relates to a print advertisement, which, while containing claims and representations about the drug's benefits, fails to adequately communicate important warnings and precautions listed in the product labeling, including vulnerability to opioid overdose, the agency said. In addition to requesting the company immediately cease advertising practices that misbrand Vivitrol, the FDA is requesting that Alkermes include a comprehensive plan of action to disseminate “truthful, non-misleading and complete corrective messages about the issues discussed in this letter to the audiences that received the violative promotional materials.” The FDA has requested that Alkermes provide a written response to the warning letter to the agency by Dec. 16. Vivitrol is approved for the prevention of relapse to opioid dependence, following opioid detoxification and is designed to be used as part of a comprehensive management program that includes psychosocial support.

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