The U.S. Food and Drug Administration today posted a warning letter to Alkermes, Inc. of Massachusetts, for inaccurately branding the drug Vivitrol (an extended-release injection formulation of naltrexone) by omitting warnings about the most serious risks associated with the drug from promotional materials. Vivitrol is approved for the prevention of relapse to opioid dependence, following opioid detoxification and should be part of a comprehensive management program that includes psychosocial support. Known as medication-assisted treatment, the use of medications like Vivitrol, in combination with counseling and behavioral therapies, is effective in the treatment of opioid use disorder (OUD) and can help some people to sustain recovery. The warning letter was issued in relation to a print advertisement about Vivitrol. While the print advertisement contains claims and representations about the drug’s benefits, it fails to adequately communicate important warnings and precautions listed in the product labeling, including vulnerability to opioid overdose, a potentially fatal risk.
“One way the FDA protects the public health is by ensuring that prescription drug information disseminated by drug sponsors is truthful, balanced and accurately communicated. We do this by reviewing prescription drug advertising and promotional labeling to ensure that the information contained in these promotional materials is not false or misleading,” said Thomas Abrams, director of the FDA’s Office of Prescription Drug Promotion in the FDA’s Center for Drug Evaluation and Research. “Vivitrol is being promoted in a way that does not adequately present important risk information in a truthful and non-misleading manner. This is concerning from a public health perspective because of the potential for fatal opioid overdose in this vulnerable patient population.”
The FDA is requesting the company immediately cease advertising practices that misbrand Vivitrol. In addition, because the violations described in the warning letter are serious, the FDA is also requesting the company include a comprehensive plan of action to disseminate truthful, non-misleading and complete corrective messages about the issues discussed in this letter to the audience(s) that received the offensive promotional materials.