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CDC Should Promptly Facilitate Administration of Botulinum Antitoxin to People with Illnesses Linked to Counterfeit “Botox”

Public Citizen Also Urges CDC to Fully Investigate Other Possible Causes of Illnesses

Washington, D.C. — The Centers for Disease Control and Prevention (CDC) is investigating 19 cases in nine states of people who developed illnesses related to what the agency called counterfeit “Botox” or mishandled botulinum toxin injections. The Food and Drug Administration (FDA) has also issued a drug safety alert about the administration of these products “to consumers for cosmetic purposes.” As of April 15, nine people were hospitalized, four had been treated with botulinum antitoxin and none had died. The investigation is ongoing.

In December 2023, Public Citizen petitioned the FDA for stronger safety warnings for Botox and related drugs. Public Citizen urged the agency to promptly highlight the risk of iatrogenic botulism in the labeling of all seven approved Botox and related drugs and remove misleading promotional claims from the labeling of Botox and Botox Cosmetic.

Azza AbuDagga, Ph.D., a health services researcher for Public Citizen’s Health Research Group, released the following statement:

“The CDC should promptly follow its guidelines that recommend the administration of botulinum antitoxin, the only specific therapy for botulism, as quickly as possible to all cases with signs or symptoms that are suggestive of botulism. Published reports have shown that dramatic or marked clinical improvements have occurred when the antitoxin is belatedly administered — even after the 10th or 12th day following the initial development of systemic symptoms.

“As it continues to investigate, the CDC should fully consider the possibility that at least some of the cases may be related to iatrogenic botulism. Iatrogenic botulism is a complication of treatment with Botox and related drugs — the FDA-approved drugs, including the doses in the prescribing information — due to their potential for diffusion and systemic spread beyond injection sites, resulting in progressive muscle paralysis, severe weakness and breathing distress.

“The outbreak of illnesses related to botulinum toxin injections underscores the urgent public health importance of strengthening the safety warnings of Botox and related drugs. The FDA should promptly consider and respond to Public Citizen’s petition.”