FDA issues warning letter to Alkermes over opioid addiction treatment ad

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 http://bit.ly/2LGVKUM to the company. 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 …read more

Source:: Yahoo Finance

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