FDA Criticizes AbbVie for Misleading Ad Featuring Serena Williams Promoting Migraine Drug Ubrelvy

FDA Warning:
The FDA issued a warning letter to AbbVie on August 29, 2024, criticizing a direct-to-consumer television ad for Ubrelvy, a migraine treatment, featuring tennis star Serena Williams.

Misleading Claims:
The ad was found to make false or misleading representations about the efficacy of Ubrelvy, suggesting it provides greater benefits and acts more swiftly than demonstrated in clinical trials.

Clinical Evidence:
Clinical studies show that only 19% to 22% of patients experienced pain relief within two hours of taking Ubrelvy, which is significantly lower than what the ad implies.

Celebrity Influence:
The FDA noted that using a celebrity like Serena Williams amplifies the misleading nature of the ad, making the claims seem more credible to audiences.

Corrective Action:
The FDA has requested that AbbVie halt distribution of the ad and provide a corrective plan within 15 working days to address the violations.

Public Health Concerns:
The FDA emphasized that these violations are concerning from a public health perspective, as they may mislead healthcare providers, patients, and caregivers about the benefits of acute migraine headache treatments.