The U.S. Centers for Disease Control and Prevention (CDC) this week issued a “health alert network” advisory regarding the risks of fake Botox injections after false versions of the product were found in several U.S. states.
Adverse fake Botox reactions have been confirmed in New York, California, Texas, Florida, Illinois, New Jersey, Tennessee, Kentucky, Colorado, Kentucky, Washington state, and Nebraska. At least 11 people who reported symptoms have been hospitalized so far, the CDC said, adding that no deaths have been reported.
The patients, ages 25 to 59, reported symptoms between November 2023 and March 2024, and 91 percent said they received Botox for cosmetic reasons, the agency said. Symptoms included dry mouth, slurred speech, shortness of breath, fatigue, weakness, blurred vision, and drooping eyelids.
The counterfeit Botox products have the lot number C3709C3 on the carton or vial, the FDA notice said. The outer packaging may say that the active ingredient in the product is “Botulinum Toxin Type A” rather than “OnabotulinumtoxinA,” said the agency, adding that the outer carton may have language that isn’t English.
The CDC health alert was primarily sent to health care officials and practitioners about the risks of Botox, which is derived from the botulinum toxin. It said that clinicians and health departments should consider the possibility that counterfeit Botox injections could be the cause of adverse effects “in patients presenting with localized paralysis.”
“When botulinum toxin diffuses around the injection site, it can result in adverse effects. Botulism is the disease caused by botulinum toxin circulating in the blood and producing effects remotely from the injection site,” the alert said. “There may be symptom overlap between the presentation of localized adverse effects from injection of botulinum toxin, especially in the head and neck, and the early symptoms of botulism.”
Officials and doctors “should immediately contact their state, tribal, local, or territorial health department if they suspect botulism,” the agency said.
“Botulism is the disease caused by botulinum toxin circulating in the blood and producing effects remotely from the injection site. There may be symptom overlap between the presentation of localized adverse effects from injection of botulinum toxin, especially in the head and neck, and the early symptoms of botulism,” according to the CDC health advisory.
Botulism can be treated with an antitoxin, which, according to health officials, only limits the toxin from causing more damage. It cannot reverse the damage that was already done. However, if the disease isn’t treated, it could lead to more serious issues such as paralysis, the CDC warned.
“Botulinum toxin should be administered only by licensed providers, using only recommended doses of FDA-approved botulinum toxin, preferably in a licensed or accredited healthcare setting,” the CDC said in its advisory. “Providers should be trained in the proper administration of botulinum toxin, practicing in accordance with state and local requirements.”
“The sources of these products are unverified and unknown, which is why this situation is certainly concerning,” Michelle Waltenburg, senior botulism epidemiologist with the CDC, told NBC News in a recent interview.
In response to the counterfeit Botox reports, AbbVie and Allergan Aesthetics, the only pharmaceutical firms that make the FDA-approved versions of Botox, issued a statement to several news outlets. They both said their companies are the only ones who are authorized to supply the product in the United States.
Some local health authorities have also said that people looking to get the cosmetic treatment should be aware of the counterfeit products.
