FDA blasts Alkermes for underselling the risks of opioid addiction drug Vivitrol
The FDA is chastising Alkermes for “misbranding” Vivitrol, the controversial drug meant to treat opioid addiction.
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.
