FDA issues warning to Alkermes over Vivitrol opioid addiction treatment ad

The Food and Drug Administration said the ad is 'false' and 'misleading'

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.

GET FOX BUSINESS ON THE GO BY CLICKING HERE

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.

SUPREME COURT REJECTS ARIZONA CASE AGAINST OPIOID MAKER PURDUE'S SACKLER FAMILY

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.

CLICK HERE TO READ MORE ON FOX BUSINESS

Shares of the company were down 2.2 percent at $21.1.

(Reporting by Manojna Maddipatla in Bengaluru; Editing by Sriraj Kalluvila)

Load more..