FDA warns that Serena Williams ad for migraine drug is misleading
The FDA recently wrote a letter to pharmaceutical giant AbbVie, asking the company to stop advertising a migraine drug featuring tennis legend Serena Williams.
The letter states that advertising for Ubrelvy makes “false or misleading representations” about the drug and may lead migraine sufferers to believe that “all patients taking Ubrelvy can expect their migraine pain to disappear after a single dose of Ubrelvy, when this has not been demonstrated.”
The company is being asked to come up with a plan to stop advertising or cease distribution of the drug.
AbbVie reported that sales of Ubrelvy and a similar migraine drug, Qulipta, generated $1.223 billion in revenue for the company in 2023.
This is the second time the FDA has warned a pharmaceutical company about Ubrelvy ads. Before Ubrelvy was owned by AbbVie, it was owned by Allergan, which was acquired by AbbVie in 2019
Serena Williams attends day seven of the 2024 US Open Tennis Championships in New York. The tennis star previously revealed that she suffers from migraines and takes prescription medication to cope with them
This isn’t the first time the agency has raised concerns about Ubrelvy advertising. The company that originally promoted the drug, Allergen, received a similar letter before being acquired by AbbVie in 2019.
Ms Williams, who has won more Grand Slam titles than any player in the Open, has previously shared that she suffers from migraines. In
The tennis legend said People in 2021 that her migraines became debilitating during the pandemic and that she found relief with medications, which could only be prescribed by a doctor.
Ubrelvy is taken as a 50 or 100 mg pill. The cost of the drug without insurance would be about $1,000 for ten tablets, but could be less with AbbVie discounts or insurance coverage. With insurance, Amazon lists the medicine price $35.
Similar drugs include Nurtec, Ajovy, Emgality, and Aimovig, all of which are produced by different companies.
A study earlier this year found that 65 percent of people could prevent migraines by taking the pill before their migraines started.
While these may be encouraging results for the 39 million Americans who suffer from migraines, the drug was no miracle cure. It didn’t work for all 518 patients who took part in the trial, which was published in the journal Neurology.
Despite this, The FDA letter stated: The advertisement gave the impression that the drug would work in every patient who took it.
It said: ‘These violations are concerning from a public health perspective as the TV ad, starring Serena Williams, misleadingly suggests that Ubrelvy provides greater treatment benefits to migraine sufferers than has been shown.’
In general, these types of letters are rare: the FDA has sent only four so far in 2024.
AbbVie told Bloomberg News that they will no longer air the commercial after the first half of the year and that this is in accordance with the FDA’s investigation.