Harmful reactions linked to counterfeit or mishandled “Botox” injections

 Download/Print Risk Alert (PDF)

April 17, 2024
The Centers for Disease Control and Prevention (CDC), several state and local health departments, and the U.S. Food and Drug Administration (FDA) are alerting health care professionals and consumers that unsafe, counterfeit versions of Botox (botulinum toxin) have been found in multiple states.  
 
As of April 12, 2024, 19 people have reported harmful reactions after receiving Botox injections, which appear to have been purchased from unlicensed sources. According to the CDC, nine of the 19 patients were hospitalized and four were treated with botulism antitoxin after experiencing symptoms similar to those observed when botulinum toxin spreads to other parts of the body, including blurry vision and double vision, drooping eyelids, dry mouth, slurred speech, difficulty swallowing or breathing, fatigue, and generalized weakness. The other five patients were tested for botulism; all of their results were negative.
 
More information about the counterfeit Botox products, including signs of counterfeit versions, may be found on the FDA’s website.
 
Dental professionals should be aware that purchasing and administering medications purchased from unlicensed sources puts patients at risk, as the products may be misbranded, adulterated, contaminated, counterfeit, improperly stored, or otherwise unsafe. Federal law requires that all health care providers who dispense or administer prescription drugs purchase those products only from authorized sources. Regardless, it is advisable to check products for any signs of counterfeiting, tampering, or contamination before use.
 
Dentists can visit the FDA’s website for information about how to safely purchase prescription drugs at: Know Your Source: Protecting Patients from Unsafe Drugs.
 
 
_{References
CDC. (2024, April 15). Harmful Reactions Linked to Counterfeit “Botox” or Mishandled Botulinum Toxin Injections. Centers for Disease Control and Prevention. https://www.cdc.gov/botulism/outbreaks/harmful-reactions-botox-injections.html
Edwards, E. (2024, April 15). CDC investigating botched Botox shots in 9 states. NBC News. https://www.nbcnews.com/health/health-news/cdc-investigating-botched-botox-shots-9-states-rcna147947
FDA. (2024, April 16). Counterfeit Version of Botox Found in Multiple States. U.S. Food & Drug Administration. https://www.fda.gov/drugs/drug-safety-and-availability/counterfeit-version-botox-found-multiple-states
FDA. (2018). Know Your Source: Protecting Patients from Unsafe Drugs. U.S. Food & Drug Administration. https://www.fda.gov/drugs/information-health-care-professionals-drugs/know-your-source-protecting-patients-unsafe-drugs}