Serena Williams Ubrelvy Ad Is Misleading, FDA Says

A television ad for a migraine drug featuring legendary tennis player Serena Williams is misleading, the Food and Drug Administration (FDA) says.

In a rare warning issued on Wednesday on the agency’s website, the FDA said the commercial of Ubrelvy (ubrogepant) violates the Federal Food, Drug, and Cosmetic Act (FD&C Act) by making false or misleading representations and suggestions about the drug’s efficacy.

“These violations are concerning from a public health perspective because the TV ad, featuring Serena Williams, misleadingly suggests that Ubrelvy will provide a greater treatment benefit to patients suffering from migraine headache than has been demonstrated,” the agency said in a statement.

The ad shows William sitting in a talk show dressing room and experiencing migraine symptoms like headache and photophobia, a heightened sensitivity to light. After a single 100 mg dose of Ubrelvy, the tennis legend is symptom-free and walks onto the talk show stage, smiling and waving to the studio audience.

According to the FDA, the ad suggests that the drug eliminates migraine symptoms more quickly than was demonstrated in the clinical trials, where only about 19% to 22% of patients achieved pain freedom two hours after receiving one Ubrelvy dose.

AbbVie, the maker of Ubrelvy, told Bloomberg News that it is actively addressing the FDA enforcement action regarding the ad, which stopped airing in the first half of this year. The company said it “will continue to further correspond with the FDA on this matter.”

The 23-time Grand Slam champion has publicly talked about her struggles with migraine, a condition that led to losses on the court and became more frequent during the COVID-19 pandemic.

Migraine is among the most common neurological conditions, affecting at least 39 million Americans, mostly women. As it can cause debilitating symptoms lasting for hours or days, migraine stands as the second highest cause of disability globally.