WASHINGTON — The Food and Drug Administration on Wednesday chastised the pharmaceutical company Alkermes for “misbranding” Vivitrol, its controversial treatment for opioid addiction, saying the company’s promotional materials failed to warn patients and doctors of the serious risks associated with the drug.
The company failed to sufficiently communicate the risk of overdose associated with Vivitrol, which is one of three FDA-approved medications used to treat opioid use disorder. While Vivitrol guards against opioid cravings and relapse for people in recovery from opioid addiction, it reduces opioid tolerance and leaves its users more vulnerable to opioid overdose for patients who relapse, even at comparatively low doses.
“Vivitrol is being promoted in a way that does not adequately present important risk information in a truthful and non-misleading manner,” Thomas Abrams, director of the FDA’s Office of Prescription Drug Promotion, said in a statement. “This is concerning from a public health perspective because of the potential for fatal opioid overdose in this vulnerable patient population.”
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