Public Citizen, a consumer advocacy group, lodged a formal request with the U.S. Food and Drug Administration (FDA) urging for enhanced cautionary measures within the labels of Botox and similar injections. Their plea centered on the necessity for heightened warnings concerning the potential risk of a severe muscle-paralyzing ailment, which could prove fatal.

While these injections, utilizing diverse types of botulinum toxins to target specific muscles and erase wrinkles, currently carry a ‘black box’ warning detailing the hazards of the intended effect spreading to other areas, Public Citizen pressed for more explicit indications that these adverse effects might transpire even when administered at recommended dosages. Their petition specifically targeted six toxin-based injections, encompassing the prominent Botox by AbbVie, Daxxify by Revance Therapeutics, Jeuveau by Evolus, Myobloc by Supernus Pharmaceuticals, Dysport by Galderma, and Xeomin by Merz Therapeutics. In addition to advocating for clearer warnings on the labels, Public Citizen requested the FDA eliminate promotional statements asserting the absence of definitive serious side-effects linked to the distant spread of the toxin effect associated with these treatments. Their initiative stemmed from an extensive analysis encompassing over 5,400 reported instances of fatalities, life-threatening incidents, and other severe side effects related to Botox and rival toxin-based wrinkle treatments. This scrutiny was based on records from the FDA’s adverse events database, aimed at identifying unusual or emerging side effect patterns necessitating further investigation or regulatory measures, like adding warnings to a product. The group’s petition was prompted by the need for explicit alerts about systemic iatrogenic botulism, a condition capable of causing progressive muscle paralysis if the toxin extends beyond the designated treatment area.