FDA Issues Warning Letter to Alkermes

The U.S. Food and Drug Administration (FDA) posted a warning letter to Alkermes of Massachusetts, for misbranding 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 violative promotional materials.

Specifically, the labeling states that after opioid detoxification, patients are likely to have reduced tolerance to opioids. For approximately 28 days after administration, Vivitrol is designed to block the effect (known as blockade) of an opioid. As the blockade wanes and eventually dissipates completely, patients who have been treated with Vivitrol may respond to lower doses of opioids than previously used. Therefore, if a patient uses opioids at the same dose they previously used, after taking Vivitrol and as the blockade wanes or after missing a dose or discontinuing treatment, it could result in an opioid overdose. There is also the possibility that a patient who is treated with Vivitrol could overcome the opioid blockade effect of Vivitrol. The print advertisement about Vivitrol also omits other important warnings and precautions including the risk of injection site reactions and other common adverse reactions associated with the use of drug. The FDA has requested that Alkermes, Inc. provide a written response to the warning letter to the FDA by Dec. 16.

The warning letter posted today reflects the agency’s commitment to protect the public health by ensuring that prescription drug information is truthful, balanced and accurately communicated as well as the agency’s focus on addressing the opioid crisis, which remains one of the FDA’s top public health priorities. The FDA continues to look at ways to facilitate treatment options to address OUD as a chronic disease with long-lasting effects. There are three drugs approved by the FDA for the treatment of opioid dependence: buprenorphine, methadone and naltrexone. All three of these treatments have been demonstrated to be safe and effective in combination with counseling and psychosocial support.

Health care professionals and consumers should report any adverse events related to these and other drugs to the FDA’s MedWatch Adverse Event Reporting program. To file a report, use the MedWatch Online Voluntary Reporting Form. The FDA monitors these reports and takes appropriate action necessary to ensure the safety of medical products in the marketplace.

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