As counterfeit Botox cases rise, health officials continue to warn clinicians of risks
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Key takeaways:
- The CDC has confirmed an increase in botulism-like illnesses from 19 to 22 cases nationwide.
- Health care professionals are instructed to watch out for counterfeit Botox products and report any new cases.
As cases of botulism-like illnesses continue to rise, the CDC has issued a Health Alert Network Health Advisory to warn clinicians about risks associated with counterfeit or mishandled botulinum toxin injections.
The alert follows the CDC’s prior announcement that it will be investigating cases of counterfeit and mishandled botulinum toxin injections, commonly called Botox (Allergan), that have been administered by unlicensed or untrained individuals or in non-health care settings, such as homes or spas.
As of April 12, the CDC confirmed that 19 people in nine states reported harmful reactions after receiving fake Botox injections. The agency is now stating that, as of April 23, 22 people across 11 states have reported adverse effects after receiving these injections, and 11 have been hospitalized.
The states affected include California, Colorado, Florida, Illinois, Kentucky, Nebraska, New Jersey, New York, Tennessee, Texas and Washington.
The CDC continues to advise clinicians and health departments to suspect botulism if any patients are presenting localized paralysis following Botox injections and report the case to their local health department. Additional symptoms to look out for include blurred vision, dry mouth, slurred speech, shortness of breath, fatigue and generalized weakness.
The FDA has also released a health warning with detailed information on how clinicians can spot counterfeit Botox.
Botox is produced in 50-, 100- and 200-unit dose forms. The counterfeit product’s outer cartons and vials indicate 150-unit doses, which is not an available dose of the authentic injectable.
Authentic Botox cartons will read either “BOTOX COSMETIC / onabotulinumtoxinA / for Injection” or “OnabotulinumtoxinA / BOTOX / for injection.” The manufacturer identified on the outer carton should be either “Allergan Aesthetics / An AbbVie Company” or “abbvie” and the active ingredient “onabotulinumtoxinA” should be listed on the outer carton and vial.
On the other hand, counterfeit Botox cartons will display the active ingredient as “Botulinum Toxin Type A.” Additionally, if the outer carton and vial contain lot number C3709C3 or a language other than English, the product is counterfeit.
The FDA urges health care professionals and consumers to report adverse events of counterfeit Botox to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
Reference:
- Counterfeit version of Botox found in multiple states. https://www.fda.gov/drugs/drug-safety-and-availability/counterfeit-version-botox-found-multiple-states. Updated April 18, 2024. Accessed April 24, 2024.
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