The FDA just wrote a letter to pharmaceutical giant AbbVie, asking it to stop running an advertisement for a migraine drug that features tennis legend Serena Williams.
The letter details that Ubrelvy’s advertising “makes false or misleading representations” about the drug and could lead migraine patients to believe that “all patients taking Ubrelvy can expect their migraine pain to be eliminated after a single dose of Ubrelvy, when this has not been demonstrated.”
Ask the company to come up with a plan to stop running the ad or discontinue distribution of the drug.
AbbVie reported that sales of Ubrelvy and a similar migraine drug called 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 advertising Ubrelvy. 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 tournament in New York. The tennis star has previously shared that she suffers from migraines and takes prescription medication to treat them.
This is not the first time the agency has raised concerns about Ubrelvy’s advertising. The company that originally promoted the drug, Allergen, received a similar letter before it was acquired by AbbVie in 2019.
Ms Williams, who has won more Grand Slam singles titles than any player in the open area, has previously shared that she suffers from migraines.
The tennis legend told People in 2021 that her migraines became debilitating during the pandemic and that she found relief in medication, which must be prescribed by a doctor.
Ubrelvy is taken in 50 or 100 mg tablets. The cost of the drug without insurance would be around $1,000 for ten tablets, but could be less with AbbVie discounts or insurance coverage. With insurance, Amazon lists the price of the medicine at $35.
Other similar drugs include Nurtec, Ajovy, Emgality, and Aimovig, all made by different companies.
A study earlier this year suggested that taking the pill before a migraine occurred helped 65 percent of people prevent it.
While these results may be encouraging for the 39 million Americans who suffer from migraines, the drug was not a cure-all. It did not work for the 518 patients who participated in the trial, which was published in the journal Neurology.
Despite this, The FDA letter said: The ad made it seem like the drug would work for all patients who took it.
It said: “These violations are concerning from a public health perspective because the television advertisement, featuring Serena Williams, misleadingly suggests that Ubrelvy will provide greater treatment benefit to migraine sufferers than has been demonstrated.”
Overall, such letters are rare: The FDA has issued only four so far in 2024.
AbbVie said Bloomberg News that they had stopped airing the ad after the first half of the year and that this is in compliance with the FDA investigation.