Advocacy group petitions FDA for stronger safety warnings for Botox, related drugs
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Key takeaways:
- The petition demands the FDA clarify the risk for systemic iatrogenic botulism associated with Botox and related drugs.
- The petition is supported by data from the FDA’s Adverse Event Reporting System.
An advocacy organization has petitioned the FDA to promptly highlight and clarify the risk for botulism on seven approved Botox and related drugs, according to a press release.
The petition submitted by Public Citizen, a nonprofit consumer advocacy organization, has asked the FDA that black box warnings of both cosmetic and therapeutic Botox (onabotulinumtoxinA, Allergan) and related drugs clarify the risk for systemic iatrogenic botulism, also known as descending muscle paralysis or weakness, associated with these drugs.
“Our petition is based on clear post-marketing 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,” Azza AbuDagga, MHA, PhD, health services researcher at Public Citizen’s Health Research Group, said in the release.
The petition is supported by data from the FDA’s Adverse Event Reporting System from January 1989 to March 2021. The data includes 5,414 reports of “serious outcomes” from Botox, including death, life-threatening events, hospitalization or disability. In each of these cases, Botox or a related drug was the only primary suspect, according to the press release.
Public Citizen has also requested that the FDA remove three “misleading” promotional statements from Botox and Botox Cosmetic labels. The statements include claims that the drug does not cause serious adverse events related to distant spread of the toxin when the recommended dosage is used for certain indications. The petition argues that because these statements are not listed on Botox and Botox Cosmetic products in other countries, such as Canada and the U.K., they should not be on U.S. products.
Perspective
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A consumer advocacy organization has issued a petition to the FDA to include risk of serious adverse events to Botox labeling. They present FDA Adverse Event Reporting System data indicating iatrogenic botulism from Botox spread in the body — including visual disturbances; difficulty breathing, swallowing and speaking; weakness; fatigue; and paralysis — resulting in hospitalization and, in rare cases, death. They identified 5,414 reports, of which 21.74% were cosmetic and 78.26% were medical therapeutic. Further, serious outcomes included hospitalization in 30.51%, disability in 9.99% and death in 9.44%. The petition urges the FDA to include risk of severe systemic iatrogenic botulism and remove from the labeling that no definitive serious adverse events have been reported.
The petitioners included reports that listed Botox as the “primary suspect,” and excluded those with multiple products, accidental or inadvertent administration, injection errors and overdose. An important criticism is that they “did not exclude reports of doses that exceed the maximum doses for respective Botox products.” The labeling currently states that “there has not been a confirmed serious case of spread of toxin effect away from the injection site when Botox has been used at the recommended dose.” Therefore, the labeling change would require eliminating reports where the dose exceeded the maximum dose.
These data and allegations compel a thorough investigation into the identified cases. A report of 71 instances of iatrogenic botulism in Turkey was associated with off-label intragastric Botox injection for obesity. U.S. cases must be analyzed to confirm drug used, medical or cosmetic indication, dosage, injection method, site and dose per injection to establish a clear temporal and causal link between serious adverse events and Botox at recommended doses. Under section 505(o)(4).4, the FDA may consider forming a multidisciplinary team to evaluate the foregoing potential new safety information that should be incorporated into Botox’s labeling.
References:
Islam MR, et al. Ann Med Surg (Lond). 2023;doi:10.1097/MS9.0000000000000711.
Guidance for industry safety labeling changes — Implementation of section 505(o)(4) of the FD&C Act. https://www.fda.gov/media/116594/download. Published July 2013. Accessed January 2024.
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