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Severe Illnesses Linked to Injection of Botox Products from Unlicensed Sources

alert clinicians about risks of counterfeit or mishandled botulinum toxin injections, particularly from unlicensed sources and in non-medical settings.

 following botulinum toxin injections among Louisiana residents. One patient received injections of an unlicensed botulinum toxin product 

, and one patient received injections from an individual with unknown licensure in a 

. These patients began experiencing botulism-like symptoms a few days following the injections, and 

both experienced severe illness requiring hospitalization

 is a rare and sometimes fatal illness caused by botulinum toxin. Initial botulism 

double or blurred vision, drooping eyelids, slurred speech, difficulty swallowing, and difficulty breathing

. These symptoms can be followed by a descending, symmetric 

A suspected case of botulism is a clinical and public health emergency. 

Treating patients with botulism antitoxin early in the course of disease can prevent the progression of paralysis and consequent complications.

Botulinum toxin products can be safe and effective for cosmetic and medical applications when obtained from authorized suppliers of products approved by the U.S. Food and Drug Administration (FDA) and administered by licensed and trained providers. Healthcare providers and the public should be aware of the 

serious risks associated with injection of non-FDA-approved products

. Unlicensed products may be misbranded, adulterated, counterfeit, contaminated, improperly stored and transported, ineffective, or unsafe. 

 could increase the risk of harm, even when using FDA-approved products.

Recommendations for Healthcare Professionals

·  Consider the possibility of adverse effects from botulinum toxin injection, including for cosmetic reasons, when patients present with signs and symptoms consistent with botulism near the injection site.

.  Be aware of symptom overlap between the presentation of localized adverse effects from injection of botulinum toxin and the early symptoms of botulism. To help distinguish early botulism symptoms from localized adverse effects:

.  Assess for symmetry of cranial nerve palsies; symmetric cranial nerve palsies are expected with botulism.

.  Assess for progression of cranial nerve palsies, possibly followed by a descending symmetric flaccid paralysis. These should raise suspicion for botulism.

LDH’s Infectious Disease Epidemiology Clinician 24/7 Hotline at 800-256-2748

·  If public health clinical consultation supports botulism, 

.  Antitoxin binds only to circulating toxin in the bloodstream. Careful consideration of dose, injection site, symptom presentation, and timing can help determine the need for antitoxin. Importantly, antitoxin does not:

.  Try to get information about the source and strength of the botulinum toxin products, the administration method (e.g., self-injection or injection by a licensed, trained provider), the administration site, and if others were injected with the same product.

.  Make note of details that might indicate the patient received injections with botulinum toxin products from unlicensed sources, including whether the patient:

·  Report suspected botulism immediately to LDH’s Infectious Disease Epidemiology Clinician 24/7 Hotline at 800-256-2748.

·  Report adverse events related to the use of any medications, including unverified botulinum toxin products, to 

FDA’s MedWatch Safety Information and Adverse Event Reporting Program

.  Counsel patients who report using or being interested in using botulinum toxin about risks for potential adverse effects.

·  Advise patients to receive injections only from licensed providers who are trained in proper administration of FDA-approved botulinum toxin products and practicing in accordance with state and local requirements.

·  Diagnostic testing for suspected botulism may be done through CDC.

.  Laboratory confirmation of botulism is done by demonstrating the presence of botulinum toxin in serum through either mouse bioassay or mass spectrometry.

.  For further guidance on submitting clinical specimens for testing, contact LDH’s Infectious Disease Epidemiology Clinician 24/7 Hotline at 800-256-2748.

Harmful Reactions Linked to Counterfeit “Botox” or Mishandled Botulinum Toxin Injections

Counterfeit Version of Botox Found in Multiple States

Notes from the Field: Illnesses After Administration of Presumed Counterfeit Botulinum Toxin in Nonmedical Settings — Tennessee and New York City, March 2024

Information for Health Professionals on Botulism

1. Rao AK, Sobel J, Chatham-Stephens K, Luquez C. Clinical Guidelines for Diagnosis and Treatment of Botulism, 2021. MMWR Recomm Rep. 2021;70(No. RR-2):1–30.

2. Rao AK, Lin NH, Jackson KA, Mody RK, Griffin PM. Clinical Characteristics and Ancillary Test Results Among Patients With Botulism — United States, 2002–2015. Clin Infect Dis. 2018;66(suppl_1):S4–S10.