General Warnings

US Consumer Group Urges FDA to Strengthen Warnings on Botox and Similar Treatments

In a move aimed at enhancing consumer safety, Public Citizen, a prominent consumer advocacy group, has submitted a petition to the U.S. Food and Drug Administration (FDA) on Tuesday, urging the regulatory body to mandate stronger warnings on the labels of Botox and several similar injections. The petition specifically addresses the potential risk of a severe and potentially fatal muscle-paralyzing disease associated with the use of these cosmetic treatments. As of now, these injections carry a ‘black box‘ warning about the risk of the intended effects spreading to other areas, but Public Citizen is calling for a more explicit acknowledgment that these adverse effects could occur even when the recommended dosages are administered.

The petition targets six toxin-based injections, including the widely used Botox by AbbVie, Daxxify by Revance Therapeutics, Jeuveau by Evolus, Myobloc by Supernus Pharmaceuticals, Dysport by Galderma, and Xeomin by Merz Therapeutics. Public Citizen emphasizes the necessity for increased transparency and consumer awareness regarding the potential risks associated with these popular cosmetic procedures.

The advocacy group’s concern is rooted in the analysis of over 5,400 reports of deaths, life-threatening events, and other serious side effects related to Botox and rival toxin-based wrinkle treatments. These reports, spanning from January 1989 to March 2021, were sourced from the FDA’s adverse events database, which the agency utilizes to monitor and identify emerging side effect trends. Public Citizen asserts that the current ‘black box’ warnings inadequately convey the risk of systemic iatrogenic botulism, a condition that can result in progressive muscle paralysis if the toxin spreads beyond the intended treatment site.

Notably, the FDA has pledged to review the petition and respond directly to Public Citizen. Meanwhile, AbbVie’s Botox, a market leader in the cosmetic industry, is at the forefront of these concerns. The company asserts that it vigilantly tracks the FDA adverse event database and regularly submits safety reports to the agency. In contrast, Revance and Evolus declined to comment, and other companies, including Supernus Pharmaceuticals, Galderma, and Merz Therapeutics, did not respond to requests for comment.

Public Citizen’s call for stronger warnings is not without precedent. A previous petition filed by the advocacy group in 2008, based on an analysis of 180 reports, resulted in the FDA introducing the current ‘black box’ warning about the risk of Botox’s effect spreading to other areas of the body. Now, the organization seeks to go further by urging the FDA to include a clearer warning about the risk of botulism associated with Botox and similar treatments. Surprisingly, the term “botulism” is mentioned only once in the labeling of Botox and related drugs, and Public Citizen contends that this is insufficient given the potential gravity of the associated risks.

Azza AbuDagga, the health services researcher for Public Citizen, emphasizes that the reported 5,400 adverse events might be an underrepresentation of the actual occurrences. Citing a study that found less than a tenth of adverse events related to drugs are reported, AbuDagga underscores the importance of robust warning labels and increased transparency to protect consumers. Additionally, Public Citizen is urging the FDA to emphasize in labels that cases of botulism associated with recommended doses of these products require prompt administration of botulinum antitoxins to prevent disease progression.

As the FDA assesses the petition, the outcome could potentially reshape the regulatory landscape surrounding cosmetic treatments that utilize botulinum toxins. The consumer advocacy group’s efforts underscore the ongoing need for vigilant oversight and communication of potential risks and long-term side effects of botox to ensure the safety of individuals seeking these popular aesthetic procedures.


Joan David-Leonhard

Joan David Leonhard is a recent Pharm.D graduate with a strong passion for the pharmaceutical industry and a particular interest in pharmaceutical media and communication. Her brief internship experience includes roles in pharmacy where she built strong patient-pharmacist relationships and a pharmaceutical media internship where she actively contributed to drug information articles, blog posts, social media engagement, and various media projects.
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