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.
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.
Shares of the company were down 2.2 percent at $21.1.
(Reporting by Manojna Maddipatla in Bengaluru; Editing by Sriraj Kalluvila)