Serena Williams under fire as FDA takes action over ‘misleading’ ad by migraine drug maker

A migraine drug once endorsed by Serena Williams has come under fire amid accusations that ads exaggerate its effectiveness.

A month ago, on August 29, the Food and Drug Administration notified drugmaker AbbieVie that an ad for its prescription drug Ubrelvy featuring a star tennis player was misleading.

The federal agency took issue with the ad, which was distributed 4 years ago, on the time when Williams revealed that she had suffered from chronic migraines throughout her athletic profession.

She touted the drug as a source of “relief” as she navigated the pandemic lockdowns while mothering then-little Olympia Alexis Ohanian, a wife, a businesswoman.

“Honestly, I don’t know if I’ve had any migraine attacks since I started taking Ubrelvy,” she said. People in April 2021. “And thank God for that, because they are devastating and dealing with them can be really awful,” she added.

The FDA alleges AbbieVie used Williams’ fame to bolster misleading claims concerning the drug’s effectiveness in treating debilitating headaches.

The agency highlighted scenes from the ad wherein the 23-time Grand Slam champion suffered a migraine in a chat show dressing room. A hallway with vibrant lights transforms right into a blue path that she walks with ease, a 100-milligram bottle of the drug in her hand.

“When a migraine strikes, you have a choice. Do you endure it with compromise or treat it? Or do you endure the pain and symptoms?” Williams says within the narration. “With Ubrelva, there’s another option. One dose works quickly to eliminate the pain of a migraine,” he continues.

As the industrial progresses, we eventually see her laughing and smiling without pain. The FDA noted that the storyboard detailing the industrial didn’t indicate the time gap between the opening scenes and the scenes where Williams is shown experiencing relief.

Other ads showed Williams training in boxing, playing tennis and stuck in traffic, reaching for a 100mg bottle to ease her troubles. “Isn’t she rich enough???? why is she selling drugs?” someone wrote on YouTubewhere you’ll find archives of her collaboration with AbbieVie.

Elsewhere on Twitter, another person described using celebrities to advertise drugs as a “dark moment in medical history.”

“These claims and presentations falsely suggest that Ubrelvy provides greater benefit to patients with severe migraine headaches than has been demonstrated,” he wrote. FDA.

It continued: “This convincing ‘before and after’ presentation, coupled with claims such as ‘One dose quickly eliminates migraine pain’ and ‘Ubrelvy quickly eliminates migraine pain,’ misleadingly suggests that Ubrelvy eliminates migraine pain and symptoms more quickly than has been shown in clinical trials.”

The drug’s effectiveness was tested in two separate studies. One examined its effect on pain two hours after a single dose of fifty mg or 100 mg, and the opposite assessed its ability to alleviate migraine symptoms, such as nausea and photosensitivity, using the identical control (dose and time-frame).

According to the FDA, the outcomes don’t support the claims that “Some people were pain-free within 2 hours” and that “One dose works quickly to eliminate migraine pain” were misleading marketing claims that weren’t demonstrated in clinical trials. Between 19 and 22 percent of participants experienced pain relief; conversely, 78 to 81 percent of web sites didn’t experience this after a single dose.

The company had 15 days from receipt of the letter to reply to the discrepancies. It could either defend its drug descriptions or be required to offer details of actions to stop promotional communications that violate the FD&C Act and to stop distributing Ubrelva.

Additionally, in a written response, they might also defend the drug against allegations that it violates federal statute.

The ad described within the letter is not any longer available to observe on the prescription drug’s YouTube page, and Williams’ name and likeness have been faraway from Ubrelva’s website. However, the Aug. 17, 2020, post that the athlete was paid to share together with her thousands and thousands of Instagram followers still exists with comments disabled.