Counterfeit 'Botox' Spreading Across the U.S., CDC Warns

 The CDC is investigating harmful botulism-like reactions in 19 people who received counterfeit or mishandled botulinum toxin (Botox), according to a new reportopens in a new tab or window

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The FDA also issued its own alertopens in a new tab or window today, with information for healthcare providers on how to identify the counterfeit products.

As of April 12, nine people have been hospitalized after receiving the botulinum toxin injections, primarily for cosmetic purposes.

The people who received the injections were all women, and ranged in age from 25 to 59 years. All affected people reported that they received the injections in non-healthcare settings, such as homes or spas, or from unlicensed or untrained individuals, the CDC said. The injections appear to be counterfeit products or products with unverified sources, the report said, and investigation into the sources of these products is ongoing.

According to the FDA, there is no indication that any of the reported events were linked to AbbVie's FDA-approved Botox. The genuine product should be considered safe and effective, the FDA alert said.

Cases have been reported across nine states, including Colorado, Florida, Illinois, Kentucky, Nebraska, New Jersey, New York, Tennessee, and Washington. Affected individuals reported experiencing symptoms similar to botulism, including vision changes, drooping eyelids, difficulty swallowing, dry mouth, slurred speech, difficulty breathing, fatigue, and generalized weakness, the report said.

According to the CDC, four of the nine hospitalized patients required treatment with botulism antitoxin, but the other five people tested negative for botulism.

The CDC warning comes after an announcement on April 8 from the Illinois State Health Departmentopens in a new tab or window that alerted healthcare providers to two cases of patients showing symptoms similar to botulism after receiving botulinum toxin injections or possibly a counterfeit product. Both had received injections from a licensed nurse who was performing work outside her authority.

If patients present with signs and symptoms consistent with botulism, healthcare providers should be alert to the possibility of adverse effects from botulinum toxin injections, the CDC urged. Clinicians should immediately notify their health department for consultation and antitoxin release, the report said. If their local health department cannot be reached, clinicians can contact the CDC clinical botulism service 24/7 at 770-488-7100.

Clinicians should also contact their state or local health departments for guidance on reporting any botulinum toxin-associated adverse effects.

The FDA alert advised clinicians that they should check products for any signs of counterfeiting before use and noted that the counterfeit product can be identified by one or more of the following:

• Outer carton and vial contain lot number C3709C3
• Outer carton displays the active ingredient as "Botulinum Toxin Type A" instead of "OnabotulinumtoxinA"
• Outer carton and vial indicates 150-unit doses, which is not a unit made by AbbVie or Allergan
• Outer carton contains language that is not English

If patients report using or being interested in receiving botulinum toxin injections, clinicians should encourage them to receive treatments only from licensed providers who are properly trained in administering FDA-approved products, preferably in a licensed or accredited healthcare setting. Also, patients who report using or being interested in botulinum toxin injections should be counseled about the risks of botulism and potential adverse events.

Also, healthcare providers and consumers should report adverse events related to the use of any medications, including suspected counterfeit medications, to FDA's MedWatch Safety Information and Adverse Event Reporting Programopens in a new tab or window.

https://www.medpagetoday.com/publichealthpolicy/productalert/109687