The FDA sent a warning letter to Alkermes Dec. 11 for failing to warn against potentially fatal risks associated with its drug, Vivitrol, which is used to treat opioid addiction.
Vivitrol is a monthly injection that helps stop opioid cravings for people recovering from addiction, but it also reduces tolerance to opioids, which leaves users at a greater chance of overdosing if they relapse.
The FDA is asking Alkermes to immediately stop any advertising that misbrands Vivitrol and send corrective messages to audiences that received the misbranded promotional materials.
The ads also omit other important warnings and precautions, including risk of injection site reactions and other common adverse reactions associated with the drug, the FDA wrote.
The agency gave Alkermes a deadline of Dec. 16 to submit a response.
Read the full letter here.
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