A migraine drug once endorsed by Serena Williams has come under fire amid ads that overmarketed its usefulness.
Last month, on August 29, the Food and Drug Administration notified drugmaker AbbVie that an advertisement featuring the tennis phenom for its prescription drug Ubrelvy was misleading.
The federal agency took issue with an ad distributed four years ago. During that time, Williams revealed that she had long struggled with chronic migraines throughout her playing career.
The wife, then-toddler daughter Olympia Alexis Ohanian, cited the drug as a source of “relief” as she navigated first-time motherhood and pandemic lockdowns.
“I don’t know if I’ve had migraine attacks since I started taking Ubrelvy, honestly,” she told PEOPLE in April 2021. to deal with,” she added.
The FDA contends that AbbieVie used Williams’ reputation to amplify misleading representations about the drug’s ability to treat debilitating headaches.
The agency highlighted footage of an ad that depicted the 23-time Grand Slam champion suffering from a migraine while in a dressing room at the show. A hallway of twinkling lights turns into a blue passageway and she eases down with a 100 mg packet of pills in her hand.
“When you have a migraine, you’re faced with a choice. Get rid of it with trade or treatment? Or push through the pain and symptoms?” Williams says in a voiceover. “There’s another option with Ubrelvy. One dose works faster to relieve migraine pain,” she adds.
As the ad progresses, she is finally seen smiling and laughing without any pain. The FDA pointed out that a storyboard describing the ad did not mention the time lapse between the initial scenes of Williams experiencing relief and the scenes of Williams experiencing relief.
Other ads showed Williams doing a boxing workout, playing tennis, and getting stuck in traffic as she reached for a 100 mg pack to relieve her anxiety. “Isn’t she rich enough???? Why is she selling drugs?” someone wrote on YouTube, where archives of her partnership with Abby can be found.
Today my neurologist was like “this migraine medicine is Lady Gaga, this is Serena Williams” and it was a dark moment in medical history.
— Alison (@OnlineAlison) February 5, 2024
Elsewhere on Twitter, another described the use of celebrities to push drugs as “a dark moment in medical history”.
“These claims and presentations misleadingly suggest that Ubrelvy provides greater benefit to patients with acute migraine headaches than has been demonstrated,” the FDA wrote.
This potency before and after presentation combined with claims such as “one dose works faster to relieve migraine pain” and Ubrelvy ‘relieves migraine pain faster’ misleadingly suggest that Ubrelvy relieves migraine pain and symptoms faster than indicated. In clinical trials.”
Two separate trials tested the efficacy of the drug, one determining its effect on pain two hours after a single dose of 50 mg or 100 mg, the other on its ability to blunt migraine symptoms such as nausea and light sensitivity with the same controls (dose and time frame). .
According to the FDA, “some people had pain relief within 2 hours” and that “one dose works faster to relieve migraine pain” is not supported by evidence and is a misleading marketing ploy that has not been demonstrated in clinical trials. Between 19 and 22 percent of participants experienced pain relief; Conversely, 78 to 81 percent of the parties did not have that experience after one dose.
The company has been given 15 days after receiving the letter to respond to the discrepancies. They may want descriptive actions to protect their information about the drug or to stop promotional communications that violate the FD&C Act, as well as to stop distribution of Ubrelvy.
In addition, they can also defend the drug against claims that it violates federal law, in a written response.
The ad described in the article is no longer available for viewing on the prescription drug’s YouTube page, and Williams’ name and likeness has been removed from the Ubrelvy website. However, a post on August 17, 2020 that the actress was paid to share with her millions of Instagram followers still has disabled comments.
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