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Consumer advocacy group Public Citizen has filed a petition with the FDA, urging the agency to demand stronger warnings regarding the risk of a potentially fatal muscle-paralyzing disease linked to Botox and similar injections.
These treatments, leveraging botulinum toxins to target specific muscles and erase wrinkles, currently carry a 'black box' warning about the potential for the intended effects to spread to other areas.
The petition targets six toxin-based injections, including AbbVie Inc's (NYSE: ABBV) Botox, Revance Therapeutics Inc's (NASDAQ: RVNC) Daxxify, Evolus Inc's (NASDAQ: EOLS) Jeuveau, Supernus Pharmaceuticals Inc's (NASDAQ: SUPN) Myobloc, Galderma's Dysport, and Merz Therapeutics' Xeomin.
Public Citizen, whose earlier petition in 2008 led to the current black box warning, now seeks a more distinct alert about the risk of botulism associated with these treatments.
They stress that the term "botulism" is barely mentioned in the labeling, primarily appearing toward the end of the prescribing information.
After analyzing over 5,400 adverse event reports related to Botox and similar treatments, spanning between January 1989 to March 2021, from the FDA's database, the advocacy group is pushing for clearer labeling to highlight that these adverse effects might occur even at recommended doses, Reuters noted.
The group specifically calls for a clear caution about systemic iatrogenic botulism, a condition capable of causing progressive muscle paralysis if the toxins spread beyond the intended treatment site.
The FDA states it will review the petition and respond directly to Public Citizen.
Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.
