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Alkermes omitted warnings about serious risks from taking the drug.
FDA warned Alkermes for misbranding Vivitrol, a medication-assisted treatment for opioid use disorder, by omitting warnings about the most serious risks associated with the drug from its marketing materials.
Vivitrol, an extended-release injection formulation of naltrexone, is approved for the prevention of relapse to opioid dependence, following opioid detoxification. The treatment should be part of a comprehensive management program that includes psychosocial support, FDA said in a statement.
FDA issued a warning letter over Alkermes’ print ad, which contains claims and representations about the drug’s benefits but “fails to adequately communicate important warnings and precautions listed in the product labeling, including vulnerability to opioid overdose, a potentially fatal risk,” FDA said.
“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 Thomas Abrams, director of FDA’s Office of Prescription Drug Promotion in FDA’s Center for Drug Evaluation and Research, in the statement.
FDA is also asking the company to 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,” FDA said.
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,” FDA said.
There is also the possibility that a patient who is treated with Vivitrol could overcome the opioid blockade effect of Vivitrol, the agency added.
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 drug.