Health
Consumer Advocacy Group Urges Stricter Warnings on Botox and Similar Treatments
Highlights
- Public Citizen petitions FDA for stronger warnings on Botox and similar treatments
- Emphasis on potential risk of severe muscle-paralyzing conditions
- Existing “black box” warning highlighted, but petition seeks clarity on adverse effects at recommended doses
- Six toxin-based injections targeted in the petition
- Advocacy group calls for removal of promotional statements claiming no serious side effects
- Over 5,400 reports of deaths and serious side effects documented in FDA’s adverse events database
- Specific request for clear warnings about systemic iatrogenic botulism
- Successful 2008 petition prompted existing black box warning
- Concerns raised about underreporting of adverse events
- Urgency for FDA to highlight cases requiring prompt administration of botulinum antitoxins in labels.
Public Citizen, a consumer advocacy group, recently submitted a petition to the U.S. Food and Drug Administration (FDA), seeking stronger warnings on products such as Botox and other injections using botulinum toxins. Their petition emphasizes the potential risk of severe muscle-paralyzing conditions caused by such products.
These injections, intended to treat wrinkles by blocking nerve signals in specific muscles, already carry a “black box” warning on their labels that highlights risks that their intended effects might spread to unintended places. Public Citizen has submitted a petition to FDA in which it urges them to clarify that adverse effects could still occur even at recommended dosage levels.
The proposed petition seeks a warning label of six toxin-based injections, such as Botox from AbbVie, Daxxify from Revance Therapeutics, Jeuveau from Evolus, Myobloc from Supernus Pharmaceuticals Myobloc from Galderma Dysport from AbbVie Dysport from Galderma Merz Therapeutics Xeomin from Merz Therapeutics and Xeomin from Merz Therapeutics.
Public Citizen is also calling on pharmaceutical manufacturers and retailers to remove promotional statements which claim there are no serious side effects from distant toxin effects.
Public Citizen issued its call for stricter warnings following an analysis conducted by Public Citizen that documented over 5,400 reports of deaths, life-threatening events and serious side effects related to Botox and similar wrinkle treatments between January 1989 and March 2021 in the FDA’s adverse events database.
The group is specifically asking the FDA to include clear warnings about systemic iatrogenic botulism, a condition in which toxin spreads past its original treatment site and causes progressive muscle paralysis.
Public Citizen has submitted its petition and requested an FDA response directly, while companies associated with these products have given various responses: Merz has mentioned closely monitoring FDA adverse event databases; Revance and Evolus declined commenting while other firms did not reply to our inquiries for comment.
Public Citizen had successfully submitted a petition in 2008 based on an analysis of 180 reports to prompt FDA to add its existing black box warning about Botox’s effects spreading. Their current petition seeks a clearer warning about botulism associated with these treatments.
Public Citizen health services researcher Azza AbuDagga of Public Citizen notes that reported adverse events may be underreported; she cites research indicating only 10% of adverse drug events are ever reported to authorities. Furthermore, Public Citizen urges FDA to highlight in labels cases associated with recommended doses that require prompt administration of botulinum antitoxins in order to stop disease progression and provide antitoxins as soon as possible to combat disease progression.
