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Dec 11 (Reuters) – A print advertisement of Alkermes Plc’s addiction treatment, Vivitrol, is false or misleading as it omits important risk information associated with its use, the Food and Drug Administration said in a warning letter to the company.
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Users of Vivitrol as a treatment for opioid dependence should be made aware of the vulnerability to potentially fatal overdose at the end of a dosing interval, after missing a dose, or after discontinuing the treatment, the agency said in the letter dated Dec. 2.
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Vivitrol is safe and effective for the prevention of relapse to opioid dependence when used as provided in the FDA-approved product labeling, the FDA said.
The company did not immediately respond to a request for comment.
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Shares of the company were down 2.2% at $21.1.
(Reporting by Manojna Maddipatla in Bengaluru; Editing by Sriraj Kalluvila)
