Counterfeit Botox Alert: Identifying Concerns and Ensuring Safety  

Medical Aesthetics Professionals
Medical Aesthetics Professionals
Counterfeit Botox Example usage

In April 2002, the U.S. Food and Drug Administration (FDA) approved Botox® to help temporarily reduce the appearance of the glabellar lines between the eyebrows. Now 22 years later, Botox remains one of the most popular and widely used cosmetic treatments in the industry. In fact, statistics show that Botox use increased by a massive 380% from 2002 to 2020, with over 4.4 million Botox procedures having been performed in 2020 in the U.S. alone. Further statistics for 2020 also reveal that Botox injections accounted for a total of 48.6% of all nonsurgical cosmetic procedures in the U.S. These numbers provide a clear indication of the immense demand and explosive growth of Botox over the years.

Moreover, Botox has not only proven its effectiveness in reducing the appearance of fine lines and wrinkles in cosmetic applications but has also gained recognition in the medical field as its usage has also expanded to encompass the treatment of various medical conditions, including migraines.

However, as demand for Botox continues to rise, this has created an avenue for counterfeiters to enter and target this lucrative market. Recent news revealing the use of counterfeit Botox has, understandably, caused significant concern among both providers and their patients. As investigations continue, it is necessary for all concerned to be aware of the potential risks and how to avoid them.

CDC and FDA Investigate Counterfeit Botox

The Centers for Disease Control and Prevention (CDC) revealed they are investigating the discovery of counterfeit or mishandled Botox which caused at least 19 women in nine different states to become sick after receiving Botox injections. Reports state that nine of the patients had to be hospitalized and four treated with botulism antitoxin as caregivers became concerned that the botulinum toxin could have spread beyond the injection site. Some of the symptoms experienced included blurred vision, dry mouth, difficulty swallowing, constipation, incontinence, difficulty lifting one’s head, and shortness of breath, all of which are similar to what happens when botulinum toxin spreads to other parts of the body.

According to the CDC, the patients are aged between 25 and 59 years old and all “reported receiving these injections from unlicensed or untrained individuals or in non-healthcare settings, including homes and spas.”

The FDA is involved in the investigation alongside the CDC, as are the state health departments and Botox manufacturer, AbbVie. The CDC and FDA have also provided both health care professionals and consumers with recommendations for moving forward as investigations continue.

For providers this includes:

  • Consider the possibility of adverse effects from Botox injections when patients present with signs and symptoms consistent with botulism near the injection site.
  • Counsel patients who report using or being interested in using Botox about the risks of botulism and potential adverse events.
  • Encourage patients to receive injections only from licensed providers who are trained in proper administration of FDA-approved Botox, preferably in a licensed or accredited healthcare setting.
  • Check the product for any signs of counterfeiting before using it.
  • Purchase prescription drugs only from authorized sources.
  • Utilize FDA’s website for information on how to safely purchase prescription drugs for their patients – Know Your Source: Protecting Patients from Unsafe Drugs

For consumers this includes:

  • Ask your provider and setting (such as clinic or spa) if they are licensed and trained to give the injection. CDC reveals that your state might have a license look-up tool where you can check if a provider or setting has the appropriate license.
  • Ask if the product is approved by FDA and obtained from a reliable source.
  • See your healthcare provider or go to the emergency room immediately if you have any symptoms of botulism, including:
  • Blurry or double vision
  • Drooping eyelids
  • Difficulty swallowing
  • Difficulty breathing
  • Muscle weakness
  • If in doubt, do not get the injection.

Signs of Counterfeit Botox

The announcement by the FDA has further pointed out the similarities between the FDA-approved Botox and the counterfeit Botox, some of which are outlined in the table below:

Protecting Your Patients

As expected, several dermatologists and aesthetic professionals have weighed in on this recent situation, including Lavanya Krishnan, MD, a board-certified dermatologist in San Francisco. She founded Arya Derm, and states, “the best way to find a licensed provider is to go to the company websites for these products — say you wanted Botox, you would go to the company Allergan’s website, and Allergan actually should have a list of licensed providers who they are selling their product to.” Dr. Krishnan adds that counterfeit products are often also sold at much lower prices, which should be a tip-off to the purchaser that this is not a good product.

Cosmetic dermatologist, Karan Lal, DO, MS, shares the same opinion as Dr. Krishnan. “If your Botox is so inexpensive to the point that it doesn’t make sense compared with other people that are charging a different amount in your area, that means there is a problem. This could mean they are diluting the Botox, they are using counterfeit Botox, or they are using Botox from outside of the U.S.” He adds that “in addition to making sure you have standard Botox that was stored correctly, you must also make sure that sterile techniques are used when preparing botulinum toxins.” This reduces the risk of complications.

Concluding Thoughts

The issue of counterfeit Botox is a serious situation and necessitates attention from all providers. It is essential that we all remain informed about ongoing investigations. By educating patients about the risks, emphasizing the importance of receiving treatments only from licensed professionals, and fully explaining the potential side effects of Botox, you can ensure you are doing your part in keeping your patients safe.

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Medical Aesthetics Professionals
Medical Aesthetics Professionals
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