The Centers for Disease Control and Prevention — along with the U.S. Food and Drug Administration and local and state health departments — continue to investigate after 19 people in nine states experienced adverse reactions after botulinum toxin injections.
The injections were either counterfeit or administered by unlicensed or untrained individuals and/or in non-healthcare settings, including homes or spas, according to the CDC.
On Tuesday, the FDA issued alarm to health professionals and consumers that “unsafe counterfeit versions of Botox” have been found in several states, warning that fake or mishandled Botox products can lead to serious complications.
What is Botox?
Botulinum toxin is a neurotoxic protein made from a toxin produced by the bacterium Clostridium botulinum.
It blocks the chemical signals from the nerves that cause the muscles to contract. The muscles temporarily relax, reducing the appearance of wrinkles. Botox is the most common brand name of the injection.
A fake box of botulinum toxin or Botox. Several people in the U.S. have become ill after fake or mishandled Botox injections, according to the CDC.
CDC.gov
Botox is most often used on the face to reduce forehead lines, frown lines and crow’s feet, but it can also be used for people with excessive underarm sweating, muscle disorders such as cerebral palsy, neck spasms, overactive bladder, migraines and other ailments.
Why can Botox injections be dangerous?
Forms of pure botulinum toxin have been approved by the FDA for certain medical and cosmetic treatments, according to the Mayo Clinic.
They are considered safe when administered by licensed healthcare providers who meet medical review standards as dictated by the FDA.
However, when Botox is not prepared, stored, or administered properly, it can lead to a rare but serious disease called botulism, which is when the toxin attacks the body’s nerves. This can cause muscle paralysis, difficulty breathing and even death.
Botulism is treated with an antitoxin, which prevents the toxin from causing further damage, According to the CDC. Fewer than five in 100 people with botulism die, the agency says.
But even with antidotes and medical care, people can suffer from fatigue or shortness of breath for years after the infection clears.
What you need to know about the latest series of diseases?
So far, 19 people in nine states — including Colorado, Florida, Illinois, Kentucky, Nebraska, New Jersey, New York, Tennessee and Washington — have reported harmful reactions, according to the CDC.
The patients — all of whom were women — received the injections from unlicensed or untrained individuals or in non-healthcare settings.
Patients’ ages ranged from 25 to 59 years, and the vast majority, 95%, reported receiving injections for cosmetic purposes.
Patients said they experienced a variety of symptoms including blurred vision, double vision, drooping eyelids, dry mouth, difficulty sweating, slurred speech, fatigue, weakness, difficulty breathing.
Nine were hospitalized and four were treated with botulism antitoxin due to concerns that the botulinum toxin could have spread beyond the injection site.
According to the CDC, five patients were tested for botulism. The results were negative.
If you are considering botulinum toxin injections
If you’re thinking about getting Botox, the CDC recommends asking your provider if they’re licensed and trained to give the injection. Some states have tools that allow patients to look up whether a provider or setting is properly licensed.
Additionally, patients should ask if the product is FDA approved and if it was obtained from a reputable source.
If there is any doubt about the provider, setting, or product, the CDC advises against the injection.
“Botox injections are a medical procedure and should only be performed in an office setting by board-certified dermatologists or an appropriately trained non-medical clinician under the direct on-site supervision of a board-certified dermatologist,” according to statement from the American Academy of Dermatology.
If you get the injection and experience symptoms of botulism, the CDC says to see your health care provider or go to the emergency room right away.
How to tell if a Botox product is fake
AbbVie and Allergan — which is part of AbbVie — are the only approved makers of Botox, and there is currently no evidence that harmful reactions are linked to the genuine product, according to the FDA.
There are some indications that a version may be counterfeit, including the outer box and vial containing the batch number C3709C3 as well as the outer box listing the active ingredient as “Botulinum Toxin Type A” instead of “OnabotulinumtoxinA”.
If the outer carton and vial indicate doses of 150 units, this is counterfeit because it is not a unit manufactured by AbbVie or Allergan. Genuine products are available in doses of 50, 100 and 200 units.
In addition, outer cartons containing a non-English language are counterfeit.
Individuals who suspect counterfeit Botox products are encouraged to file a report with the FDA.
