01:21 PM EDT, 09/11/2024 (MT Newswires) -- AbbVie's ( ABBV ) TV ad featuring tennis star Serena Williams has been criticized by the US Food and Drug Administration for making "misleading" claims about the migraine drug Ubrelvy, according to a warning letter posted Wednesday on the FDA's website.
The FDA letter said the claim in the ad that "one dose works fast to eliminate migraine pain" is misleading and suggests that all patients can expect their migraine pain to be completely eliminated after just one dose. This effect "has not been demonstrated," the FDA letter said.
The agency also said that featuring a celebrity athlete "amplifies" the misleading claims and increases the likelihood that audiences will find the deceptive messaging believable due to the athlete's perceived credibility.
AbbVie ( ABBV ) is required to respond to the letter within 15 working days with a plan to either stop the ads and related materials or halt the distribution of Ubrelvy, with the option to contest the regulatory claims.
AbbVie ( ABBV ) did not immediately respond to requests for comment by MT Newswires.
The company's shares were down 1.9% in recent Wednesday trading.
Price: 196.07, Change: -3.29, Percent Change: -1.65