OPDP reprimands Merz over Instagram ad for Botox competitor Xeomin

The US Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) sent an untitled letter to Merz Pharmaceuticals concerning a recent paid Instagram post promoting its Botox competitor Xeomin (incobotulinumtoxinA).

The post in question was made by both Merz on its Xeomin Aesthetics Instagram account and interior designer Nate Berkus on his personal account and depicts Berkus getting ready to co-host AD100 at Art Basel in Miami last December, who frets that “you never know when those lines might decide to make a surprise appearance.”

Berkus continues saying that his dermatologist recommended Xeomin, “a double-filtered smart tox that smooths the look of frown lines with only the ingredients that you need for treatment.”

FDA notes that the drug is indicated for the temporary improvement in appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adults and is labeled with a boxed warning for the risk of distant spread of toxin effect, as well as warnings and precautions about the lack of interchangeability with other botulinum toxin products, hypersensitivity reactions, dysphagia and breathing difficulties, and other potential issues.

“These violations are concerning from a public health perspective because the promotional communication creates a misleading impression regarding the safety and effectiveness of Xeomin, a drug with a number of serious and potentially life-threatening risks, including a boxed warning regarding the risk of distant spread of toxin effects,” FDA wrote.

FDA continues by stating the “post is misleading because it fails to present information relating to side effects and contraindications associated with the drug with a prominence and readability reasonably comparable with the presentation of information relating to the benefits of the drug,” noting that the video features an “attention-grabbing” presentation by Berkus as he gets ready for “a big night out.”

The risk information is then displayed for three seconds after the video goes black with no accompanying audio, nor does it alert the audience that such information will be presented at the end. While some risk information is contained in the caption of the video, “it can only be accessed if the viewer manually scrolls down, past additional benefit claims and other unrelated information.”

FDA also took issue with the claims made in the video, including the suggestion that “Xeomin provides faster or more rapid results than have been demonstrated.” FDA notes that the video implies that the “surprise appearance” of frown lines can be addressed in time for a same-day event.

“The efficacy of Xeomin … was evaluated based on a composite endpoint where treatment success was defined as a 2-grade improvement for both the investigator and patient assessment per the 4-point Facial Wrinkle Scale compared to baseline on Day 30. While efficacy data was also collected at other time points besides the primary endpoint at Day 30, composite endpoint treatment success was not evaluated before day 7. We are not aware of data to support the suggestion that Xeomin can provide successful treatment as rapidly as suggested in the post. If you have data to support this presentation, please submit to FDA for review,” FDA wrote.

Additionally, FDA said the claim that Xeomin includes “only the ingredients that you need for treatment” misleadingly implies that it offers benefits over other botulinum toxin products. While FDA acknowledges that Xeomin is made without accessory proteins, the agency said it is not aware of any head-to-head studies comparing the drug with its competitors to establish any “unique or added benefits.”

Untitled letter

OPDP reprimands Merz over Instagram ad for Botox competitor Xeomin

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