Is Your Botox Real Or Fake? Counterfeit Boxes Circulate For Widely Used Antiwrinkle Treatment, CDC And FDA Investigate Harmful Reactions

On Tuesday, the FDA issued a warning regarding the dangers associated with counterfeit versions of AbbVie Inc’s ABBV Botox used for cosmetic purposes. 

The alert follows reports of adverse reactions among individuals who received injections of fake Botox across several states, prompting investigations by the FDA and the Centers for Disease Control and Prevention (CDC).

Related: Botox And Similar Injections Have Associated Risks: Consumer Group Pushes for Stronger Warnings.

Nineteen cases involving harmful reactions have been documented in nine states, including Colorado, Florida, Illinois, Kentucky, Nebraska, New Jersey, New York, Tennessee, and Washington. 

These reactions occurred after individuals received injections of counterfeit Botox from unlicensed practitioners or in non-healthcare settings such as spas and homes.

Symptoms reported by patients who received the counterfeit injections include blurred or double vision, difficulty swallowing & breathing, dry mouth, slurred speech, fatigue, and generalized weakness.

Botulinum toxin, the active ingredient in Botox, is a neurotoxic protein that temporarily relaxes muscles, reducing the appearance of wrinkles. However, when administered improperly or with counterfeit products, it can lead to serious complications and adverse reactions.

Nine (60%) people were hospitalized, and 4 (21%) were treated with botulism antitoxin because of concerns that the botulinum toxin could have spread beyond the injection site. Five people were tested for botulism, and their results were all negative.

The FDA is collaborating with the CDC, state health departments, and AbbVie to investigate and address the issue of counterfeit products. 

The FDA warns health-care professionals that purchasing and administering counterfeit products puts patients’ health at risk, and all providers should check products for any signs of counterfeiting before using them.

The FDA said the counterfeit Botox products may be identified by the lot number C3709C3 on the outer carton and vial.

The outer carton also may display the active ingredient as “Botulinum Toxin Type A” instead of “OnabotulinumtoxinA.” 

The FDA also said the carton and vial may indicate 150-unit doses, which is not a unit made by AbbVie or Allergan, and the outer carton may contain language other than English.

AbbVie manufactures authentic Botox products in 50, 100, and 200-unit dose forms.

Price Action: ABBV shares are up 1.07% at $164.28 on the last check Wednesday.

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