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New Public Citizen Petition Asks FDA for Stronger Safety Warnings for Botox and Related Drugs

Petition Also Asks for Removal of Misleading Claims from Botox/Botox Cosmetic Labeling

WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) should promptly highlight the risk of botulism in the labeling of all seven approved Botox and related drugs, and remove misleading promotional claims from the Botox and Botox Cosmetic labels, Public Citizen said today in a petition to the agency.

The petition asks that the black box warning of 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 subsequent (repeated) treatment. Iatrogenic botulism is a complication of treatment with Botox and related drugs due to their potential for diffusion and systemic spread beyond injection sites resulting in progressive, typically descending muscle paralysis or weakness.

“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,” said Azza AbuDagga, Ph.D., health services researcher at Public Citizen’s Health Research Group.

Botulism may require prompt administration of botulinum antitoxin to avoid disease progression and serious outcomes, including temporary muscle paralysis, hospitalization and even death.

Using data from the FDA’s Adverse Event Reporting System (FAERS) from January 1989 through March 2021, Public Citizen identified 5,414 reports with “serious outcomes” from Botox and related product treatments — including death, life-threatening events, hospitalization, or disability. In all these reports, Botox or a related drug was the only primary suspect. A background document provides more information about the Public Citizen petition and the research on which it is based.

“Due to the voluntary-reporting nature of FAERS data, our analysis most likely underestimates the true extent of the problem,” said AbuDagga.

In addition to a strengthened black box warning, the petition asks the FDA to remove three misleading promotional statements from the labeling of Botox and Botox Cosmetic. These statements — which do not appear in similar labeling in other countries, such as Canada and the United Kingdom — 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 these drugs for certain indications.

Today’s petition builds on a 2008 Public Citizen petition that asked the FDA to require the addition of the black-box warning on the labeling of Botox and related drugs regarding the risk of distant spread of the toxin, a request the FDA granted in 2009.

“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,” said AbuDagga. “This will allow health care professionals and patients to make more informed decisions about the benefit-risk profile of these widely used drugs.”