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December 12, 2019

FDA issues warning letter to Vivitrol makers for excluding serious risks in ad

Opioids FDA
Vivitrol FDA Source/FDA

The FDA issued a warning letter to Alkermes, Inc. for misbranding of Vivitrol, an extended-release injection formulation used to treat opioid use disorder.

The U.S. Food & Drug Adminstration has issued a warning letter to Alkermes, Inc., the makers of Vivitrol, for failing to disclose the injectable drug's most serious risks in an advertisement.

Vivitrol is a medication assisted treatment drug used to prevent opioid dependence and overdose by blocking some of the pain relief and well-being derived from those drugs. It is intended to prevent relapse to opioid dependence and abuse.

The FDA's letter says the Massachusetts-based company did not adequately communicate important warnings and precautions in a print advertisement. These warnings are present in Vivitrol's product labeling.

Specifically, the advertisement omitted the fact that after opioid detoxification, patients are likely to have reduced tolerance to opioids. For approximately 28 days after administration of Vivitrol, the drug's blockade gradually wanes and dissipates.

Patients who have been treated with Vivitrol may respond to lower doses of opioids than previously used after the drug has waned. If a patient uses opioids at the same dose they previously used, it could result in an opioid overdose.

The print advertisement for Vivitrol did not cover these risks, the FDA said.

“Vivitrol is being promoted in a way that does not adequately present important risk information in a truthful and non-misleading manner," said Thomas Abrams, director of the FDA’s Office of Prescription Drug Promotion. "This is concerning from a public health perspective because of the potential for fatal opioid overdose in this vulnerable patient population.”

The FDA advises use of Vivitrol in combination with counseling and psychosocial support. Health care professionals and consumers should report any adverse events related to this drug to the FDA’s MedWatch Adverse Event Reporting program.

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