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FDA Warns Alkermes on Vivitrol Ads

— Campaign omits important risk information, agency says

MedpageToday

WASHINGTON -- A prompted an FDA warning to drug maker Alkermes that it failed to disclose the product's most serious risks.

Vivitrol is an extended-release injection formulation of naltrexone and is one of three approved drugs used to treat opioid use disorder. "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," the Wednesday.

The drug's states that after opioid detoxification, patients are likely to have reduced tolerance to opioids. For about 28 days after being administered, Vivitrol is designed to block the effect of an opioid, but as the blockade fades, patients may respond to lower doses of opioids than previously used. If patients return to using opioids at their previous dose, they could overdose.

The print ad is "false or misleading because it omits important risk information associated with the use of Vivitrol," the FDA's Center for Drug Evaluation and Research to Alkermes CEO Richard Pops. "This violation is concerning from a public health perspective because it creates a misleading impression regarding the overall safety of Vivitrol."

The ad directs readers to a promotional site about Vivitrol in the , a market Alkermes has long cultivated. Investigative reports have shown that Alkermes has used lobbyists to get about opioid abuse treatment and has persuaded over other drugs.

Last year, researchers looked at of 263 deaths and overdose-related outcomes, assessing 145 death reports for causality. Cause of death was unknown in 46%. Of 52 overdoses that met the case definition, the time between the last dose and death was known for 28; 22 (84.6%) occurred within 2 months of the last Vivitrol injection.

This suggests "the need to investigate two months following the last medicine injection as a period of particular concern for overdose," the authors concluded.

The FDA requested that Alkermes immediately cease advertising practices that misbrand the drug and include a comprehensive plan "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." The agency encouraged healthcare professionals and patients to to the FDA's MedWatch Adverse Event Reporting program.