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Public Citizen Asks CDC and FDA To Revise Recent Health Advisory on Counterfeit or Mishandled Botulinum Toxin Injections

CDC Should Consider Possibility of Iatrogenic Botulism from Approved Botox and Related Drugs

WASHINGTON, D.C. — Today Public Citizen sent a letter to the Centers for Disease Control and Prevention (CDC) Director and the Food and Drug Administration (FDA) Commissioner asking that a recent Health Alert Network (HAN) Health Advisory be revised to consider the possibility of iatrogenic botulism — a complication of treatment with all approved botulinum toxin drugs, including at recommended doses.

The Advisory concerns adverse effects in clusters of 22 people in 11 U.S. states resulting from what the CDC characterized as “counterfeit or mishandled botulinum toxin injections.”

In the letter, Public Citizen notes that the Advisory should encourage clinicians to err on the side of suspecting iatrogenic botulism in all patients experiencing adverse effects consistent with the distant spread of the botulinum toxin, including asymmetric neurological deficits, within hours to weeks after botulinum toxin injections.

In December 2023, Public Citizen petitioned the FDA for a stronger safety warning for Botox and related drugs.

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

“While the CDC and FDA conduct thorough investigations, the messaging to clinicians should be immediately improved so that all people with signs and symptoms that are reasonably suggestive of botulism will be identified and promptly receive botulinum antitoxin, the only specific therapy for botulism, as needed.

“The FDA should promptly grant our December 2023 petition to strengthen the safety warnings about iatrogenic botulism in the labeling of all approved botulinum toxin drugs and remove misleading promotional claims from the labeling of Botox and Botox Cosmetic.”