FDA Investigating Unsafe Counterfeit Botox Causing Harmful Reactions

Botulinum toxin A has become very popular in dentistry, primarily used for the treatment and/or management of temporomandibular joint disorders and trigeminal neuralgia. Botulinum toxin A is also utilized for cosmetic procedures. Other uses include the management of chronic migraines and other headaches, cervical dystonia, and strabismus, among other conditions.¹

When administered properly, botulinum toxin A is generally safe and successful at managing these conditions. However, recent reports have surfaced regarding the administration of unsafe counterfeit versions of botulinum toxin A. The U.S. Food and Drug Administration (FDA) has made an official statement warning health care professionals and consumers to be aware of the situation.²

The FDA is working with the manufacturer of Botox to identify and remove counterfeit products found in the United States.²

Harmful Reactions Reported

The Centers for Disease Control and Prevention (CDC) received reports of harmful reactions after Botox was administered and released its initial report on April 19, 2024. The initial report stated the harmful reactions occurred ranging from November 4, 2023, through March 31, 2024, identifying 11 states in which the reactions occurred.³

However, further investigation determined that the reactions occurred from November 4, 2023, through April 11, 2024, with adverse events confirmed in nine states. Adverse events linked directly to counterfeit Botox were confirmed in 17 people in the following states:³

• California: 2 people
• Colorado: 1 person
• Florida: 1 person
• Illinois: 2 people
• Kentucky: 1 person
• New Jersey: 1 person
• New York: 3 people
• Tennessee: 3 people
• Texas: 3 people

Overall, 13 (76%) of the individuals were hospitalized, and 6 (35%) were treated with botulism antitoxin due to concerns that botulinum toxin spread beyond the injection site. However, all people tested for botulism were negative. The majority of the people affected reported receiving botulinum toxin injections for cosmetic purposes.³

Symptoms reported by individuals experiencing harmful reactions included:³

• Blurry vision and double vision
• Drooping eyelids
• Difficulty swallowing
• Dry mouth
• Slurred speech
• Difficulty breathing
• Fatigue
• Generalized weakness

Reporting Adverse Reactions

The FDA has a passive reporting system to monitor adverse events that may occur post-marketing of pharmaceuticals. This reporting system is called the FDA Adverse Event Reporting System (FAERS) Public Dashboard, and it offers the ability to file a report and review reported events via its database. This reporting system helps the FDA identify clusters of reports that could indicate potential contamination of a pharmaceutical or, in this case, counterfeit products that cause harm.⁴

FAERS does not establish causality, but it can elicit an investigation to determine the causality of reports. All pharmaceuticals have a risk of adverse events, even when used properly, including Botox. A review of FAERS identified 428 cases of dysphagia, 46 cases of botulism, and 85 cases of death with Botox use, all of which were unrelated to the recent counterfeit Botox.⁴

Keeping in mind these cases must be investigated to determine causality, some of these cases have indeed been investigated. Even when botulinum toxin was assumed to be the cause of death, the mechanism in many of these reports was anaphylaxis, allergy, or hypersensitivity rather than a result of the underlying mechanism of the drug. This has led to the finding that death in all the cases reviewed did not result from the proper use and technique of botulinum toxin.⁴

However, systemic botulism associated with the systemic spread of botulinum toxin was significant in the sense that the injection did cause the botulism. These, along with other less serious adverse events, are technique-dependent. Accordingly, ensuring the individual administering the injections is properly licensed and trained is imperative.⁴

Sources of Counterfeit Botox and Inappropriate Application

When Botox is used properly and with the proper constitution and injection technique, the concerns for serious adverse events are negligible. This is important to understand as many cases in the recent counterfeit Botox report were administered by unlicensed individuals and/or in non-medical or unlicensed settings.²

Though licensed individuals administered some cases, all the counterfeit Botox was purchased from unlicensed sources. Pharmaceuticals purchased from unlicensed sources may be misbranded, adulterated, counterfeit, contaminated, improperly stored and transported, ineffective and/or unsafe. The FDA stresses that federal law requires all health care providers who dispense or administer prescription drugs must purchase these products from a licensed source.²

The FDA confirms that there is no indication that the reported events were linked to AbbVie’s FDA-approved Botox. These products are still considered safe and effective. There is no need to discontinue use of the product if it was purchased from a licensed source.²

According to the FDA, the counterfeit product may be identified by one or more of the following:²

• 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

Consumers and/or health care professionals should report any suspected counterfeit products to the FDA via the Report Suspected Criminal Activity database.

In general, Botox is considered safe and effective for the treatment/management of multiple conditions as well as for cosmetic purposes. Always confirm that the person administering Botox is licensed and/or certified in the proper technique to administer the injections. Improper technique can contribute to an increased risk of an adverse event.

Additionally, by federal law, licensed individuals are required to purchase products from licensed sources, further reducing the risk of adverse events through counterfeit, adulterated, contaminated, and improperly stored or transported products.

In Closing

Many individuals seek cheaper health care options, which often results in harm that could have been prevented if the individual were to see a licensed health care professional. Not only has this occurred recently with the administration of Botox, as described by the FDA and CDC, but there has also been an increase in reports of unlicensed individuals delivering dental treatment. This is unsafe and leaves little recourse for the consumer.

Consumers should be aware of unlicensed individuals who pose as health care professionals. Always confirm their license and ensure they are licensed to perform the treatments you will receive. Dental professionals, be aware that this unethical behavior is occurring and encourage your patients always to seek health care from a licensed professional.

Before you leave, check out the Today’s RDH self-study CE courses. All courses are peer-reviewed and non-sponsored to focus solely on high-quality education. Click here now.

Listen to the Today’s RDH Dental Hygiene Podcast Below:

References

1. Yuh, C., Shah, S. (2023, March 14). Botulinum Toxin: Mechanism of Action and Clinical Use. OpenAnesthesia. https://www.openanesthesia.org/keywords/botulinum-toxin-mechanism-of-action-and-clinical-use/
2. Counterfeit Version of Botox Found in Multiple Sates. (2024, May 1). U.S. Food and Drug Administration. https://www.fda.gov/drugs/drug-safety-and-availability/counterfeit-version-botox-found-multiple-states
3. Investigation Update on Harmful Reactions Linked to Counterfeit “Botox.” (2024, June 24). Centers for Disease Control and Prevention. https://www.cdc.gov/botulism/outbreaks/harmful-reactions-botox-injections/details.html
4. Ahsanuddin, S., Roy, S., Nasser, W., et al. Adverse Events Associated With Botox as Reported in a Food and Drug Administration Database. Aesthetic Plast Surg. 2021; 45(3): 1201-1209. https://pubmed.ncbi.nlm.nih.gov/33128076/
5. Mayo Clinic Staff. (2023, March 10). Botox Injections. Mayo Clinic. https://www.mayoclinic.org/tests-procedures/botox/about/pac-20384658