FDA Warns Vivitrol Manufacturer Over Bad Ad

Megan Brooks


December 12, 2019

The US Food and Drug Administration (FDA) has warned Alkermes Inc about leaving out warnings about its drug naltrexone in promotional materials regarding the most serious risks associated with the company's extended-release injection formulation of naltrexone (Vivitrol).

Vivitrol is approved for the prevention of relapse in patients with opioid dependence after opioid detoxification and should be part of a comprehensive management program that includes psychosocial support.

In a warning letter sent to the company, the FDA takes issue with a print advertisement for the drug.

Although the ad 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, the FDA said in a statement.

The labeling for Vivitrol states that after opioid detoxification, patients are likely to experience reduced tolerance to opioids. Therefore, if a patient uses opioids at the same dose they previously used after taking Vivitrol, it could result in an opioid overdose, the FDA explained.

The print advertisement about Vivitrol also leaves out other important warnings and precautions, including the risk for injection site reactions and other common adverse reactions associated with the use of drug, the agency said.

"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," Thomas Abrams, director of the FDA's Office of Prescription Drug Promotion in the FDA's Center for Drug Evaluation and Research, said in the release.

"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," said Abrams.

The FDA has asked the company to stop publishing advertisements that misbrand Vivitrol and that it develop a comprehensive plan of action to disseminate "truthful, non-misleading and complete corrective messages" regarding the FDA's concerns outlined in a warning letter.

Alkermes Inc has until December 16 to provide a written response to the FDA.

The FDA sponsors the Bad Ad Program, which is designed to raise awareness among healthcare professionals about misleading prescription drug promotions and to provide them with an easy way to report such promotions to the agency.

To report potentially false or misleading promotion, healthcare professionals can send an email to badad@fda.gov or call 855-RX-BADAD.

Follow Medscape on Facebook, Twitter, Instagram, and YouTube


Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.
Post as: