The U.S. Food and Drug Administration (FDA) has issued a warning to all health care professionals and consumers revealing that counterfeit versions of Botox (botulinum toxin) have been uncovered in multiple states.
There have already been reports of adverse events as a result of the unsafe Botox which includes, “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 FDA reports that these symptoms are similar to those experienced when botulinum toxin spreads to other parts of the body.
The FDA is working closely with the Centers for Disease Control and Prevention, state health departments, and manufacturers to protect the nation’s drug supply. They are also working with Abbvie, the manufacturer of Botox, to investigate the matter and identify and remove the source of the counterfeit Botox.
There is currently no indication that the reported events are linked to AbbVie’s FDA-approved Botox, therefore the genuine product should be considered safe and effective.
It has been revealed that the counterfeit Botox has been injected by both licensed and unlicensed individuals and in non-medical or unlicensed settings. The FDA statement goes on to reveal that the product appears to have been purchased from unlicensed sources, which the FDA warns, “may be misbranded, adulterated, counterfeit, contaminated, improperly stored and transported, ineffective and/or unsafe.”
According to the FDA, the counterfeit product includes counterfeiting on the outer carton and the vial. These have been identified as follows:
1. The outer carton and vial contain lot number C3709C3
2. The outer carton displays the active ingredient as “Botulinum Toxin Type A” instead of “OnabotulinumtoxinA”
3. The outer carton and vial indicate 150-unit doses, which is not a unit made by AbbVie or Allergan
4. The outer carton contains language that is not English
The FDA has provided the below images of the counterfeit products for reference:
The FDA recommends that all health care professionals check their products for any signs of counterfeiting before using it and only purchase their products from authorized sources.
For more information on how to safely purchase prescription drugs for your patients, you can visit the FDA website – Know Your Source: Protecting Patients from Unsafe Drugs.
