The U.S. advocacy group Public Citizen is taking aim at AbbVie’s medical and cosmetic injection Botox, as well as its new rivals, over safety and promotional issues with the shots.
In a petition sent to the FDA, Public Citizen asked the FDA to “remove misleading promotional statements from the labeling of Botox and Botox Cosmetic” and to "strengthen the black box warning in the labeling of all approved Botox and related drugs.”
Botox is the market leader in the medical aesthetics field, having been around for 34 years and generating around $5 billion annually for AbbVie. The Illinois-based pharma giant picked up the blockbuster drug from its buyout of Allergan in 2019.
While Botox dominates the field, Public Citizen also wants the same crackdown for the med's rivals. Those are Revance Therapeutics' Daxxify, Evolus' Jeuveau, Supernus Pharmaceuticals' Myobloc, Galderma's Dysport, and Merz Therapeutics’ Xeomin.
All of these products contain a form of a highly potent neurotoxin that can be used to treat cosmetic conditions, such as smoothing out wrinkle lines or, as is the case with Botox, also have medical labels, such as for migraines and incontinence.
But there can be serious safety risks when using these neurotoxins, and Public Citizen wants the FDA to shore up messaging around the products.
The group has a long history with Botox and originally petitioned for the drug’s black-box warning back in 2008. It argues that the current warning, which was slapped on the drug by the FDA in 2009, still does not go far enough as it “fails to explicitly mention the risk of ‘systemic iatrogenic botulism.'"
This is a potential complication of Botox treatment and related drugs that can cause muscle paralysis or weakness, the group said.
The advocacy group also wants the removal of “misleading promotional statements” from the labeling of Botox and Botox Cosmetic.
These promotional statements are also related to potential safety risks, with Public Citizen singling out the claim that “[n]o definitive serious adverse event reports of distant spread of toxin effect” were associated with the use of recommended doses of these drugs to treat four therapeutic indications (blepharospasm, chronic migraine, severe underarm sweating, and strabismus) and certain approved cosmetic uses.
It points out that regulators in other countries, including Canada and the U.K., do not use this claim, and that, when combing through the FDA’s safety database, the group said it saw that “Botox was the primary suspect when used to treat one of the four therapeutic indications listed in the misleading claims,” and that “269 (42%) included adverse reactions that were suggestive of iatrogenic botulism.”