Harmful Reactions Linked to Counterfeit "Botox" or Mishandled Botulinum Toxin Injections

Investigation Summary

Data show that injections of counterfeit or mishandled botulinum toxin (commonly called "Botox") made people sick.

• Some people received injections with counterfeit products or products with unverified sources.
• Some people received injections from individuals who did not follow jurisdictional (state or local) requirements.

FDA's drug safety announcement includes images of counterfeit products and authentic, FDA-approved products.

What you should do

If you are considering an injection of botulinum toxin for a medical condition or cosmetic reason (such as for wrinkles):

• Ask your provider if they are licensed and trained to give the injection.
  • Your state might have a look-up tool where you can check whether a provider or, if required, a setting (such as a clinic or spa) has the appropriate license.
• Ask if the botulinum toxin product is approved by FDA and obtained from a reliable source.
• If in doubt, don't get the injection.

See your healthcare provider or go to the emergency room immediately if you have any symptoms of botulism, including

• Blurry or double vision
• Drooping eyelids
• Difficulty swallowing
• Difficulty breathing
• Muscle weakness

Report problems you might have to the U.S. Food and Drug Administration (FDA).

• Report suspected counterfeit botulinum toxin products to FDA at 800-551-3989 or through FDA's form for reporting suspected criminal activity.
• Report harmful reactions related to the use of any medication, including suspected counterfeit medication, to FDA's MedWatch Safety Information and Adverse Event Reporting Program.

What healthcare providers should do

• 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.
• If systemic botulism is suspected, call your health department immediately for consultation and antitoxin release. If no one answers, contact the CDC Botulism Consultation Service 24/7 at 770-488-7100.
  • Refer to your state or local health department for guidance on reporting adverse effects.
• Counsel patients who report using or being interested in using botulinum toxin about the risks of botulism and possible adverse events.
• Encourage patients to receive injections only from licensed providers who are trained in proper administration of FDA-approved botulinum toxin and practicing in accordance with state and local requirements.
• Report harmful reactions related to the use of any medication, including suspected counterfeit medication, to FDA's MedWatch Safety Information and Adverse Event Reporting Program.

See also

• CDC Health Advisory: Adverse Effects Linked to Counterfeit or Mishandled Botulinum Toxin Injections
• FDA: Counterfeit Version of Botox Found in Multiple States