December 20, 2019

Alkermes Scolded by FDA for Misleading Advertising of Drug for Opioid Treatment

On December 11, the FDA scolded Alkermes, a pharmaceutical company, for the misbranding of Vivitrol, a treatment for opioid addiction, by failing to warn patients and physicians of the significant risk of overdose. Vivitrol is an FDA-approved medication used to treat opioid use disorder. While its uses are beneficial for combating the cravings associated with using opioids, it can leave users “more vulnerable to opioid overdose for patients who relapse, even at comparatively low doses.” According to the Director of the FDA, Thomas Abrams, the drug is “being promoted in a way that does not adequately present important risk information in a truthful and non-misleading manner”. Specifically, the advertisement at issue is a picture of a judge along with bold text declaring that Vivitrol is a “’non-addictive, once-monthly treatment option” to the opioid epidemic.