The U.S. Food and Drug Administration is taking North Chicago-based drugmaker AbbVie to task, warning in a recent letter that a migraine medication commercial featuring Serena Williams is “misleading.”
The television commercial shows Williams in a talk show dressing room, appearing to experience migraine pain, closing her eyes and holding a hand up to her head. She then starts walking and a logo for the AbbVie medication Ubrelvy appears in a backstage hallway. Williams’ face relaxes and she holds up a single dose packet of Ubrelvy. She then says: “With Ubrelvy, there’s another option. One dose works fast to eliminate migraine pain.” She’s then shown in the dressing room laughing and smiling.
The problem, the FDA says, is that a dose of Ubrelvy has not been shown in clinical trials to work immediately or for all patients.
“These claims and presentations misleadingly suggest that Ubrelvy provides greater benefits to patients with acute migraine headache than has been demonstrated,” FDA officials wrote in their letter, which was issued Aug. 29.
In that letter, the FDA asked AbbVie to cease any violations of the Federal Food, Drug, and Cosmetic Act. The FDA asked AbbVie to submit a response letter within 15 working days either explaining why it doesn’t believe it has violated the act, or addressing the FDA’s concerns, listing other promotional materials that might contain similar claims and detailing a plan to stop those communications or stop distributing Ubrelvy.
AbbVie said in a statement Thursday: “We are actively addressing the FDA untitled letter we received referencing one of our TV commercials, which stopped airing in the first half of this year. We will continue to further correspond with the FDA on this matter.”
According to the FDA letter, the commercial “misleadingly suggests that Ubrelvy eliminates migraine pain and symptoms more quickly than was demonstrated in the clinical trials.” In clinical trials described in the letter, researchers measured how well the drug relieved pain and other symptoms two hours after it was taken, according to the FDA.
The FDA also said in its letter, that the commercial’s use of the phrase, “‘One dose works fast to eliminate migraine pain,’ … misleadingly suggests that all patients who take Ubrelvy can expect their migraine pain to be eliminated after a single dose of Ubrelvy, when this has not been demonstrated.”
The FDA noted that AbbVie included the phrase, “Some people had pain freedom within 2 hours” in small text in the commercial, but said that inclusion is not enough to mitigate the “misleading” suggestions.
The FDA officials wrote that, “Moreover, the use of a celebrity athlete in this TV ad amplifies the misleading representations and suggestions made and increases the potential for audiences to find the misleading promotional communication more believable due to the perceived credibility of the source.”
AbbVie began selling Ubrelvy after it acquired drug company Allergan in 2020.
