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The CDC and FDA have launched an investigation into counterfeit Botox that they say has caused nearly 20 adverse reactions in nine states, and the agencies warn that fake injections can lead to harmful effects, including a serious illness called botulism.
Basic elements
The Centers for Disease Control and Prevention was announced On Monday it received 19 reports of people falling ill – including nine hospitalizations – after fake Botox (or botulinum toxin) injections given by unlicensed people, usually in unregulated places like spas or homes.
These cases were identified in nine states: Colorado, Florida, Illinois, Kentucky, Nebraska, New Jersey, New York, Tennessee and Washington.
Four people were treated with botulism antitoxin because doctors suspected they had symptoms that suggested the toxin might be spreading through their bodies.
All of those who experienced adverse events were identified as female, the median age was 39, and all but one reported receiving Botox injections for cosmetic reasons, according at the CDC.
Genuine Botox is made by AbbVie or Allergan and some telltale signs of a fake Botox product include language other than English on the box, the box and vial lot number C3709C3, the box saying the active ingredient is “Botulinum Toxin Type A”. instead of “OnabotulinumtoxinA” and the box saying it’s a 150-unit dose—Botox only comes in doses of 50, 100 and 200 units—according to a Tuesday announcement by the Food and Drug Administration.
There is no indication that any of the reported cases are linked to the AbbVie or Allergan product, and the FDA has confirmed that the product should continue to be considered safe and effective when used properly.
What are the symptoms of fake Botox injections?
The FDA reported that those who experienced adverse effects had symptoms such as blurred or double vision, difficulty swallowing, dry mouth, constipation, incontinence, shortness of breath, weakness, and difficulty holding up their head. Other reported symptoms included fatigue, drooping eyelids and slurred speech, according at the CDC. These bogus injections can also lead to botulism, a rare but serious disease caused by toxins that attack the nervous system. People usually survive botulism: If treated properly, the chance of dying from botulism is about five in 100, CDC References.
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 agencies 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 closing called OnabotulinumtoxinA. It was then approved in 2002 for the temporary treatment of smile lines in adults and was marketed as Botox to distinguish between its therapeutic and cosmetic uses. The average cost of Botox is usually around $530 per injection, although it varies depending on how deep the wrinkles are and how much product is used. according in the American Society of Plastic Surgeons. Botox is made from a bacterium that is only safe in small amounts and can be poisonous in large amounts. according in the American Academy of Ophthalmology. When injected for cosmetic purposes, it blocks nerve signals that cause muscles to contract, reducing wrinkles. This only lasts from three to six months, after which the muscles move and the wrinkles reappear.
Tangent line
US officials previously cracked down on unregulated Botox injections and other cosmetic treatments in 2023. Customs and Border Protection officers seized nearly 80 missions of unapproved injectable cosmetics – valued at $175,400 – in Cincinnati. The injections were shipped from China, Spain, Korea and Bulgaria to several states, including New York, Florida, South Carolina and Oregon.