CNN
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The US Centers for Disease Control and Prevention issued an advisory on Tuesday about the dangers of fake or mishandled Botox injections after dangerous counterfeit versions of the product were found in several states.
The CDC, the U.S. Food and Drug Administration, and state and local officials are working to investigate groups of at least 22 women who reported adverse reactions after fake Botox injections, injections from unlicensed or untrained providers or shots in places that weren’t healthy. care settings, such as spas or private homes, according to official CDC health advisory.
As of Thursday, these incidents have been reported in California, Colorado, Florida, Illinois, Kentucky, Nebraska, New Jersey, New York, Tennessee, Texas and Washington. Among the people who reported symptoms, 11 were hospitalized, the CDC said, but none have died.
The patients, ages 25 to 59, reported their symptoms between November and March, and most of them — 91 percent — said they received Botox for cosmetic purposes, according to the CDC. Their symptoms included blurred vision, droopy eyelids, dry mouth, slurred speech, shortness of breath, fatigue and weakness. Seven of them were tested for botulism. Test results were negative for six, while one is still pending.
These incidents appear to be linked to products purchased from unlicensed sources and then managed either by unlicensed or licensed providers, according to prior FDA announcement. The agency has warned healthcare professionals that buying and administering counterfeit products puts patients’ health at risk.
Counterfeit Botox products can be identified by the lot number C3709C3 on the outer carton and vial, according to the FDA.
The outer carton may also list the active ingredient as “Botulinum Toxin Type A” instead of “OnabotulinumtoxinA”. The carton and vial may indicate doses of 150 units, which is not a dose produced by AbbVie or Allergan, the FDA said, and the outer carton may contain language that is not English.
In Tuesday’s advisory, the CDC noted that when the botulinum toxin, known as Botox, spreads around the injection site, it can lead to side effects.
“Bolandiasis is the disease caused by botulinum toxin that circulates in the blood and causes effects at a distance from the injection site. There may be an overlap of symptoms between the occurrence of local adverse reactions from botulism injection, especially in the head and neck, and the early symptoms of botulism,” according to the advisory.
“Clinicians and health departments should consider the potential for adverse effects from botulinum toxin injections in patients presenting with localized paralysis,” the advisory says. “Clinicians should immediately contact their state, tribal, local or territorial health department if botulism is suspected.”
Botulism can be treated with antitoxin, according to the CDC. That’s why it’s important to get medical attention quickly and early in the course of the disease. If the disease is left untreated, it can progress to paralysis and other complications.
“Botulinum toxin should be administered only by licensed providers, using only recommended doses of FDA-approved botulinum toxin, preferably in an approved or accredited health care setting,” the CDC advisory says. “Providers should be trained in the proper administration of botulinum toxin, practicing in accordance with state and local requirements.”
In response to reports of fake Botox, the companies behind the FDA-approved versions, AbbVie and Allergan Aesthetics, said in a statement that they are the only authorized suppliers of Botox in the United States.
“Allergan Aesthetics, an AbbVie company, has a comprehensive supply chain security program in place to ensure that all products manufactured are safe, secure and sold through authorized distribution channels. All reports of counterfeit products are thoroughly investigated by our team and in cooperation with law enforcement and public health authorities where appropriate,” the statement read.
Providers and consumers can identify genuine Botox products by a tamper-evident seal on the package, the name “onabotulinumtoxinA” superimposed on the Botox brand name, and a hologram of the word “Allergan” on the vial label.
Botox is a trade name for the botulinum toxin, which in small doses can temporarily treat medical or cosmetic concerns such as severe underarm sweating, chronic migraines, overactive bladder and facial wrinkles.
“Botox and similar brands deliver a dilute, precise and consistent amount of botulinum toxin, while unregulated products that are not safely regulated are not reliably manufactured or subject to the same quality assurance, which can lead to over- or under-dosing.” Dr. Michael Cameron, its president and founder Cameron Dermatology and assistant clinical professor of dermatology at Mount Sinai Health System in New York, said last week.
When found in the body at high levels, botulism toxin can cause the rare but serious disease botulism or symptoms similar to those of the disease.
“Signs and symptoms of botulism include muscle weakness, vision changes, slurred speech, difficulty moving your eyes. An emergency would be if you start having difficulty breathing,” Cameron said.
“I personally recommend that if you’re getting botox for your wrinkles, you go to a board-certified dermatologist. If you are taking botox for your migraines, see a neurologist. If you’re getting Botox for your bladder problems, see your urologist,” he said. “If you feel there’s a risk or the pricing doesn’t make sense, then you could just ask to actually see the vial and inspect the Botox vial yourself.”
