FDA sends letter to drugmaker, says ad featuring Serena Williams was misleading

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The Food and Drug Administration sent a letter to AbbVie, claiming that advertisements for a migraine medicine featuring tennis legend Serena Williams are misleading.

In the FDA’s letter, the agency says the advertisements overstate the benefits of Ubrelvy. The FDA says that the treatment appears to show Williams’ migraine instantly going away when in reality, it could take multiple doses and several hours.

“Health care providers, patients, and caregivers should not be misled regarding the benefits that can be expected from acute migraine headache treatments. 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,” the FDA wrote.

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In the ad, Williams states, “With Ubrelvy, there’s another option. One dose works fast to eliminate migraine pain.”

Studies, however, show that most users do not experience a reduction of moderate to severe headache pain to no pain within two hours of a single dose. The study says between 19% to 22% of users had pain freedom after two hours.

The partnership between AbbVie and Williams began in 2020. Williams said that she has long suffered from migraine attacks.

“Serena’s endless accomplishments on and off the court make her the right spokesperson and role model to raise awareness about this debilitating disease,” Aimee Lenar, a vice president at AbbVie, said in 2020. “As a respected athlete, entrepreneur and mother, Serena continues to push boundaries time and again. She is a shining example of how to successfully navigate life’s challenges while fighting migraine. We are pleased she has been able to find relief from her migraine pain with UBRELVY.”

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The FDA approved Ubrelvy as a migraine medication in 2019.





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