U.S. FDA issues counterfeit botulinum toxin alert

Example of counterfeit packaging. Image courtesy

The U.S. Food and Drug Administration (FDA) has released an alert to healthcare professionals and consumers that unsafe counterfeit versions of Botox (botulinum toxin) have been found in multiple states and administered to consumers for cosmetic purposes.

According to the alert, the FDA is aware of adverse events, including hospitalizations, linked to the counterfeit neuromodulator. Symptoms included blurred or double vision, difficulty swallowing, dry mouth, constipation, incontinence, shortness of breath, weakness, and difficulty lifting one’s head following injection of these products. The agency notes these symptoms are similar to those seen when botulinum toxin spreads to other parts of the body.

The FDA’s investigation is ongoing, and the agency is currently working with pharmaceutical company AbbVie, which manufactures Botox, to identify, investigate and remove suspected counterfeit Botox products found in the U.S.

These incidents have occurred when counterfeit Botox is injected by licensed and unlicensed individuals or in non-medical or unlicensed settings, the alert notes. The products appear to have been purchased from unlicensed sources. Medications purchased from unlicensed sources may be misbranded, adulterated, counterfeit, contaminated, improperly stored and transported, ineffective and/or unsafe.

Currently, there is no indication that the reported events were linked to AbbVie’s FDA-approved Botox, and the genuine product should be considered safe and effective for its intended and approved uses.

The FDA advises healthcare professionals to check any Botox products for signs of counterfeiting before using them. In the alert, they list the following signs of the counterfeit product identified currently:

• The outer carton and vial contain lot number C3709C3

• The outer carton displays the active ingredient as “Botulinum Toxin Type A” instead of “OnabotulinumtoxinA”

• The outer carton and vial indicate 150-unit doses, which is not a unit made by AbbVie or Allergan

• The outer carton contains language that is not English