(Bloomberg) -- AbbVie Inc.’s TV advertisements featuring tennis legend Serena Williams make misleading claims about the effectiveness of its migraine headache medication, according to US regulators.
AbbVie’s TV spots say that all patients who take the drug, called Ubrelvy, can expect their migraine pain to be eliminated after a single dose, and that one dose works fast against migraines. None of these claims have been demonstrated in clinical trials, the FDA said in a warning letter dated Aug. 29.
“These violations are concerning from a public health perspective,” the FDA wrote, adding that “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 is required to respond to the letter within 15 working days with a plan to either discontinue the ads and any promotional materials with these claims, or to cease distribution of Ubrelvy. The company also has the option argue that its product isn’t in violation of federal advertising regulations.
“We are actively addressing the FDA enforcement action regarding the TV commercial referenced in the letter, which stopped airing in the first half of this year,” a spokesperson for AbbVie said in an emailed statement., adding the company “will continue to further correspond with the FDA on this matter.”
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