Consumer advocacy organization Public Citizen submitted a petition to the FDA urging the implementation of enhanced warnings regarding the potentially life-threatening risk of a muscle-paralyzing ailment associated with Botox and similar injections.
These injections, utilizing diverse forms of botulinum toxins to selectively contract muscles and diminish wrinkles by intercepting specific nerve signals, currently carry a ‘black box’ warning on their labels. This warning addresses the hazards of the intended effects extending to other areas. Public Citizen is specifically requesting the FDA to explicitly convey that these adverse effects can occur even when the injections are administered at recommended dosages.
The petition includes six toxin-based injections, namely
- Botox by AbbVie
- Daxxify by Revance Therapeutics
- Jeuveau by Evolus
- Myobloc by Supernus Pharmaceuticals
- Dysport by Galderma
- Xeomin by Merz Therapeutics
Public Citizen is advocating for a more robust warning on the labels of these products. The consumer group is also urging the FDA to eliminate promotional statements asserting the absence of definitive serious side effects associated with the spread of toxin effects to distant areas.
Public Citizen’s call for action is grounded in its analysis of over 5,400 reports spanning from January 1989 to March 2021, detailing deaths, life-threatening events, and other severe side effects linked to Botox and competing toxin-based wrinkle treatments. These incidents were recorded in the FDA’s adverse events database, a tool used by the agency to identify uncommon or emerging side effect patterns that may necessitate further investigation or regulatory measures, such as the addition of warnings to product labels.
The specific request to the FDA is to incorporate explicit warnings regarding systemic iatrogenic botulism, a condition that can lead to progressive muscle paralysis if the toxin extends beyond the targeted treatment site. The FDA has acknowledged receipt of the petition and committed to a direct response to Public Citizen. Merz stated its vigilant monitoring of the FDA adverse event database, regularly submitting safety reports, while Revance and Evolus refrained from commenting. Other companies mentioned in the petition did not respond to requests for comment.
The advocacy group is now urging the FDA to enhance the warning concerning the risk of botulism associated with Botox and similar treatments. Notably, the term “botulism” is mentioned once in the prescribing information for Botox.
Highlighting a potential underreporting of adverse events, Public Citizen’s health services researcher, Azza AbuDagga, cited a study suggesting that less than a tenth of drug-related adverse events are reported. The group is calling for the FDA to emphasize on product labels that cases of botulism linked to recommended doses necessitate prompt administration of botulinum antitoxins to prevent disease progression.
