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Alkermes Receives FDA Warning Letter About Misbranding Vivitrol

Agency says print ad downplayed risks

The FDA has posted a warning letter to Alkermes, Inc. for misbranding Vivitrol (an extended-release injection formulation of naltrexone) by omitting warnings about drug-related risks from promotional materials.

Vivitrol is approved to prevent relapse to opioid dependence, following opioid detoxification, in appropriate medication-assisted treatment.

The warning letter was issued in relation to a print advertisement about Vivitrol, which the FDA says fails to adequately communicate important warnings and precautions listed in the product labeling, including vulnerability to opioid overdose, a potentially fatal risk.

"This is concerning from a public health perspective because of the potential for fatal opioid overdose in this vulnerable patient population," said Thomas Abrams, director of the FDA's Office of Prescription Drug Promotion.

Stat's story about the warning letter had this headline: "FDA blasts Alkermes for underselling the risks of opioid addiction drug Vivitrol."

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 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 is requesting the company immediately cease advertising practices that misbrand Vivitrol. Because the violations 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.

The FDA has requested that Alkermes, Inc. provide a written response to the warning letter to the FDA by Dec. 16.

Source:  FDA, Dec. 11, 2019

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