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# Strengthen Botox Safety Warning: Public Citizen
- URL: https://www.fdaweb.com/strengthen-botox-safety-warning-public-citizen/
- Published: 2023-12-12T12:00:00.000Z
- Updated: 2026-09-14T14:18:25.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155970

Public Citizen says FDA should quickly highlight the risk of botulism in the labeling of all seven approved Botox (onabotulinumtoxinA) and related drugs. The advocacy group [petition](https://www.citizen.org/article/petition-to-the-fda-to-strengthen-safety-warning-for-botox-and-related-drugs-and-remove-misleading-claims-from-botox-botox-cosmetic-labeling/?ref=fdaweb.com) says the agency also should remove what it says are misleading promotional claims from the Botox and Botox Cosmetic labels.

A Public Citizen [statement](https://www.citizen.org/news/new-public-citizen-petition-asks-fda-for-stronger-safety-warnings-for-botox-and-related-drugs/?ref=fdaweb.com) says the petition asks that the Boxed Warning for both cosmetic and therapeutic Botox and related drugs should make it clear that they are associated with systemic iatrogenic botulism and related symptoms, even when used at recommended doses, in initial or repeated treatment.

“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,” says Public Citizen Health Research Group researcher **Azza AbuDagga**.

She says Public Citizen used data from the FDA Adverse Event Reporting System from 1/1989 through 3/2021 to identify 5,414 reports with “serious outcomes” from Botox and related product treatments, including death, life-threatening events, hospitalization, or disability. In all the reports, the statement says, Botox or a related drug was the only primary suspect.

In addition to strengthening the Boxed Warning, the petition also asks that FDA remove three misleading promotional statements from the labeling that claim that no definitive serious adverse events related to distant spread of the toxin’s effect have occurred with the use of recommended doses of the drugs for certain indications.

In 2008, Public Citizen asked FDA to require the addition of the Boxed Warning on the labeling of Botox and related drugs about the risk of distant spread of the toxin. The agency granted the petition in 2009.

“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,” AbuDagga concludes. “This will allow healthcare professionals and patients to make more informed decisions about the benefit/risk profile of these widely used drugs.”