At a glance
- People have developed severe illness after "do-it-yourself" (DIY) injection of botulinum toxin products from unlicensed sources.
- Consider the possibility of adverse effects from botulinum toxin injection in patients presenting with localized paralysis near an injection site.
- If you suspect botulism, call your state health department immediately for consultation. If no one answers, call CDC's Botulism Consultation Service at 770-488-7100 (24/7).
- Counsel patients about risks for serious illness from unsafe botulinum toxin products and unsafe injection practices, including DIY injection.
Introduction
Summary
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.
However, during the past few years, CDC has received increased reports of adverse events and severe illnesses requiring treatment with botulism antitoxin. These reports have been linked to the use of botulinum toxin products from unlicensed sources and to botulinum toxin products administered by providers not following state or local requirements.
This page supplements other CDC communications on the topic, including a HAN Health Advisory, an investigation summary, and an MMWR article.
Patient information
Patient characteristics and outcomes
During a recent 10-month period, state health departments reported 13 patients who were severely ill with suspected botulism after using botulinum toxin products from unlicensed sources. Below is a snapshot of observations gathered from those patients.
Median of 3 days after injection (range 0–14 days)
Ptosis, diplopia, dysarthria, dysphagia, shortness of breath, and proximal upper and lower extremity weakness
All patients reported self-injecting cosmetic botulinum toxin products purchased from unlicensed sources or having others inject them with these products.
Most people injecting these products reportedly did not have a valid healthcare license. The only exception was a provider at a medical spa who injected a patient with a product the patient had purchased from an unlicensed source.
All patients were hospitalized and received botulism antitoxin to treat suspected botulism.
Some patients required intubation and mechanical ventilation.
Testing for botulism
All patients underwent botulinum toxin testing for circulating botulinum toxin, which would confirm a diagnosis of botulism. Results were negative for all patients.
Although none of the patients met the case definition for botulism, the negative results do not rule out botulism. At the time of testing, toxin levels in serum can be below the limit of detection by laboratory tests.
Products from unlicensed sources
Some patients reported seeing ads for vendors selling cosmetic botulinum toxin products online, including on social media platforms, such as TikTok. They also reported contacting vendors and purchasing products through messaging platforms, including WhatsApp.
Fact
Recommendations for clinicians
Diagnosis
Assessment
Consider the possibility of adverse effects from botulinum toxin injection in patients presenting with localized paralysis near an 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 localized adverse effects from early botulism symptoms,
- Assess for symmetry of cranial nerve palsies. Unilateral, asymmetric cranial nerve palsies near the site of injection are a localized adverse effect, while bilateral or symmetric cranial nerve palsies increase suspicion for botulism.
- Assess for progression of cranial nerve palsies, which may be followed by a descending symmetric flaccid paralysis. This pattern also should raise suspicion for botulism.
Patient history
Ask the patient about their history of botulinum toxin injection. Gathering information about recent injections, including samples or photos of the products or their packaging, can help protect others.
Consultation and treatment
If you suspect your patient has botulism, immediately call your state health department for consultation. If the health department does not answer, immediately call CDC's Botulism Consultation Service at 770-488-7100 (24/7).
If clinical consultation supports botulism, request antitoxin immediately and begin treatment as soon as possible. Do not wait for laboratory confirmation.
Reporting illnesses
Botulism is a notifiable disease in the United States. Physicians must promptly notify their state health department of suspected cases.
Report adverse events related to the use of any medication to FDA's MedWatch Safety Information and Adverse Event Reporting Program.
Counseling patients
- Counsel patients who report using or being interested in botulinum toxin injections about risks for serious illness when using unsafe botulinum toxin products or unsafe injection practices.
- Products from unlicensed sources may be misbranded, adulterated, counterfeit, contaminated, improperly stored and transported, ineffective, or unsafe – and may cause significant or life-threatening harm.
- Advise patients to receive injections only from a provider with a valid healthcare license and the training required to properly administer FDA-approved botulinum toxin products.
- Unsafe injection practices increase the risk for infections and other harms, even when using FDA-approved products.
Patients can visit CDC's webpage, How to Stay Safe When Getting Botulinum Toxin Injections, for more information.
Recommendations for laboratories
- Diagnostic testing for suspected botulism may be done through state public health laboratories or CDC.
- Laboratory confirmation of iatrogenic botulism is done by demonstrating the presence of botulinum toxin in serum through either mouse bioassay or mass spectrometry.
- Testing varies by state. Contact your state health department or CDC's Botulism Consultation Service at 770-488-7100 (24/7) for further guidance on submitting clinical specimens for testing.
Recommendations for public health professionals
Health departments should
- Contact CDC's Botulism Consultation Service at 770-488-7100 (24/7) for consultation and antitoxin release.
- Report probable and confirmed cases of botulism to CDC through the National Notifiable Diseases Surveillance System (NNDSS).
CDC can provide guidance to health departments on conducting botulism investigations.
Recommendations for the public
Take steps to stay safe when getting botulinum toxin injections.
What to do
- Choose the right providerAsk whether your provider has a valid healthcare license and is trained to give botulinum toxin injections. Do not self-inject botulinum toxin products.
- Check the sourceAsk whether the product is from a licensed source of FDA-approved botulinum toxin.
- Watch the processAsk the provider to draw the botulinum toxin product from the labeled vial into the syringe while you watch.
- If in doubt, do not get the injectionsSeek another, properly licensed provider.
- 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.
- 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.