A print commercial of Alkermes’s addiction treatment, Vivitrol, is deceptive or misleading as it omits important risk information related to its use, the Food and Drug Administration said in a warning letter to the drugmaker.
Customers of Vivitrol as a treatment for opioid dependence must be made aware of the vulnerability to a potentially fatal overdose at the end of a dosing interval, after missing a dose, or after stopping the treatment, the company stated in the letter dated December 2.
Vivitrol, used to stop a loss to opioid dependence following detoxification and to treat alcohol dependence, is one of Alkermes’ prime-selling medicine and brought in $85.2 million in the newest reported quarter.
It stops the effects of opioids for about 28 days after administration. However, as the blockade wanes and ultimately dissipates, patients could reply to lower doses of opioids than before, resulting in potentially life-threatening intoxication, the FDA stated.
Cases of overdose with deadly results have been reported in patients who used opioids at the end of a dosing period, after missing a scheduled dose, or after stopping the therapy, the company stated.
Alkermes has promised to work with the FDA to ensure that all promotional materials are compliant with applicable laws and rules, the Dublin-based drug producer stated in an email.
Vivitrol is safe and effective for the prevention of loss to opioid dependence when used as provided in the permitted labeling, the FDA stated.