Topline
The CDC and FDA have launched an investigation into counterfeit Botox they say has caused almost 20 adverse reactions across nine states, and the agencies warn the injections from counterfeit products can lead to harmful outcomes including a serious illness called botulism.
Key Facts
The Centers for Disease Control and Prevention announced Monday it received 19 reports of people falling ill—including nine hospitalizations—after receiving counterfeit Botox (or botulinum toxin) injections administered by unlicensed people, typically in unregulated settings like spas or homes.
These cases were detected in nine states: Colorado, Florida, Illinois, Kentucky, Nebraska, New Jersey, New York, Tennessee and Washington.
Four people have been treated with botulism antitoxin because doctors suspected they had symptoms indicating the toxin might be spreading through their bodies.
All of those experiencing adverse reactions identified as female, the median age was 39 and all but one reported getting Botox injections for cosmetic reasons, according to the CDC.
Authentic Botox is manufactured by AbbVie or Allergan, and some indications of a fake Botox product include a language other than English on the carton, the carton and vial having the lot number C3709C3, the carton saying the active ingredient is “Botulinum Toxin Type A” instead of “OnabotulinumtoxinA” and the carton saying it’s a 150-unit dose—Botox only comes in 50-, 100- and 200-unit doses—according to a Tuesday announcement by the Food and Drug Administration.
There’s no indication that any of the reported cases are tied to AbbVie or Allergan’s product, and the FDA affirmed the product should continue to be viewed as safe and effective when used properly.
What Are Symptoms Of Fake Botox Injections?
The FDA indicated those experiencing harmful effects had symptoms including blurred or double vision, difficulty swallowing, dry mouth, constipation, incontinence, shortness of breath, weakness and difficulty lifting their head. Other reported symptoms included fatigue, droopy eyelids and slurred speech, according to the CDC. These counterfeit injections can also lead to botulism, a rare but serious illness triggered by toxins attacking the nervous system. People usually survive botulism: If treated properly, the chances of dying from botulism are about five out of 100, the CDC reports.
What We Don’t Know
Neither the FDA, nor the CDC know the source of the counterfeit products. The agencies have launched an investigation with state health departments to identify the source.
Key Background
Botox was first approved by the FDA in 1989 to treat two eye disorders that cause crossed eyes and uncontrollable blinking under the name OnabotulinumtoxinA. It was then approved in 2002 to temporarily treat smile lines in adults, and it was marketed as Botox to distinguish between its therapeutic and cosmetic uses. The average cost of Botox is typically around $530 per injection, though it varies depending on how deep the wrinkles are and how much product is used, according to the American Society of Plastic Surgeons. Botox is made from a bacteria that’s safe only in small amounts, and can be poisonous in large amounts, according to the American Academy of Ophthalmology. When injected for cosmetic purposes, it blocks nerve signals that cause muscles to contract, reducing wrinkles. This only lasts for between three to six months, after which the muscles move and the wrinkles reappear.
Tangent
U.S. officials previously cracked down on unregulated Botox injections and other cosmetic treatments in 2023. Customs and Border Protection officers seized almost 80 shipments of unapproved injectable cosmetics—valued at $175,400—in Cincinnati. The injections were being shipped from China, Spain, Korea and Bulgaria to several states including New York, Florida, South Carolina and Oregon.
