Public Citizen Petitions FDA for Stronger Warnings and Labeling Changes for Botox and Rival Injections

13 December 2023

Advocacy group calls for increased safety measures and removal of misleading promotional statements

The U.S. advocacy group Public Citizen has set its sights on AbbVie’s popular medical and cosmetic injection, Botox, as well as its competitors. In a recent petition to the FDA, Public Citizen urged the regulatory body to take action against misleading promotional statements and strengthen the black box warning on the labeling of Botox and related drugs. While Botox has long been the market leader in the medical aesthetics field, generating billions of dollars in revenue annually, Public Citizen is also targeting its rivals, including Daxxify, Jeuveau, Myobloc, Dysport, and Xeomin. The group highlights the potential safety risks associated with these neurotoxin-based products and calls for clearer messaging to protect consumers.

The Safety Risks of Neurotoxin Injections

Neurotoxin-based injections like Botox have gained popularity for their ability to treat cosmetic conditions such as wrinkles, as well as medical conditions like migraines and incontinence. However, Public Citizen emphasizes that there are serious safety risks associated with these treatments. The group argues that the current black box warning on Botox, which was added by the FDA in 2009, does not adequately address the potential risk of “systemic iatrogenic botulism.” This complication can lead to muscle paralysis or weakness, and Public Citizen insists that the warning should explicitly mention this risk.

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Addressing Misleading Promotional Statements

Public Citizen also takes issue with misleading promotional statements found on the labeling of Botox and Botox Cosmetic. Specifically, the group challenges the claim that there have been no definitive reports of distant spread of toxin effect associated with recommended doses of these drugs for certain therapeutic indications and approved cosmetic uses. The advocacy group points out that regulators in other countries, such as Canada and the U.K., do not make this claim. Additionally, Public Citizen examined the FDA’s safety database and found that Botox was the primary suspect in adverse reactions related to one of the four therapeutic indications listed in the misleading claims. In fact, 42% of these adverse reactions were suggestive of iatrogenic botulism.

A History of Advocacy

Public Citizen has a longstanding history of advocating for stronger safety measures regarding Botox. The group originally petitioned for a black box warning for the drug in 2008, and while progress has been made, Public Citizen believes that more needs to be done. The current petition not only calls for stronger warnings for Botox but also for its competitors. Public Citizen asserts that all neurotoxin-based injections should adhere to the same safety standards to protect consumers from potential harm.

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Public Citizen’s recent petition to the FDA highlights concerns surrounding the safety and promotional practices of Botox and its competitors. The advocacy group urges the regulatory body to strengthen the black box warning on the labeling of these products and remove misleading promotional statements. With the popularity of neurotoxin-based injections on the rise, it is crucial to address potential safety risks and ensure that consumers are well-informed. As the FDA considers these issues, the outcome of this petition could have far-reaching implications for the medical aesthetics industry and the millions of people who seek these treatments each year.

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