The FDA cited AbbVie for its direct-to-consumer television ad for Ubrelvy, featuring tennis star Serena Williams.
According to a letter released by the FDA, the advertisement makes false or misleading claims about the drug's efficacy in treating migraine pain. The agency added that the ad exaggerates the speed and extent of Ubrelvy's benefits, suggesting the medication can eliminate migraine pain more quickly and effectively than shown in clinical trials.
The FDA also noted that using a celebrity like Williams amplifies the misleading nature of the ad, making the claims seem more credible to audiences.
Clinical studies cited by the FDA show that only around 19% to 22% of patients experienced pain relief within two hours of taking Ubrelvy, significantly lower than displayed in the advertisement.
The FDA has requested that AbbVie halt distribution of the ad and provide a corrective plan within 15 working days to address the violations.