Petition Stresses the Risks of Botulism and Challenges Industry Claims of Absolute Safety
In a significant move, consumer advocacy group Public Citizen has submitted a petition to the U.S. Food and Drug Administration (FDA), urging the regulatory body to enhance safety warnings for Botox and related drugs while demanding the removal of allegedly misleading promotional statements.
The petition specifically calls for a comprehensive black box warning on both therapeutic and cosmetic Botox labels, emphasizing the risk of systemic iatrogenic botulism and related symptoms. Public Citizen contends that even when used at recommended doses, these drugs pose a risk of diffusion and systemic spread, leading to muscle paralysis or weakness.
Azza AbuDagga, Ph.D., a health services researcher at Public Citizen’s Health Research Group, asserted, “Our petition is based on clear postmarketing evidence that refutes industry propaganda claiming that Botox and related drugs are ‘always safe’ and that no ‘definitive’ cases of botulism have occurred with recommended doses.”
Botulism, a potentially serious outcome, necessitates swift administration of botulinum antitoxin to prevent severe consequences such as temporary muscle paralysis, hospitalization, and even death.
Public Citizen drew on data from the FDA’s Adverse Event Reporting System (FAERS) spanning from January 1989 to March 2021, identifying 5,414 reports of “serious outcomes” associated with Botox and related treatments. These outcomes encompassed death, life-threatening events, hospitalization, or disability, with Botox or a related drug being the primary suspect in each case.
AbuDagga acknowledged the limitations of their analysis, stating, “Due to the voluntary-reporting nature of FAERS data, our analysis most likely underestimates the true extent of the problem.”
The petition also requests the removal of three promotional statements from the labeling of Botox and Botox Cosmetic, alleging their misleading nature. These statements, absent in similar labeling in other countries, downplay the occurrence of serious adverse events related to distant spread of the toxin’s effect with recommended doses.
This latest petition builds upon Public Citizen’s 2008 initiative, which successfully led to the addition of a black-box warning regarding the risk of distant spread of the toxin in Botox labeling.
AbuDagga emphasized, “The FDA needs to implement our two requested actions quickly to warn the public in unambiguous terms about the risk of botulism associated with the use of Botox and related drugs.” This, Public Citizen argues, will enable healthcare professionals and patients to make more informed decisions regarding the widely used drugs.