In recent months, 22 people in 11 US states developed symptoms such as blurred vision and shortness of breath after receiving “fake or mishandled” Botox injections outside medical facilities, such as spas and people’s homes.
In opinion issued on Tuesday (April 23), the Centers for Disease Control and Prevention (CDC) alerted doctors to an ongoing investigation it is conducting with the Food and Drug Administration (FDA) and state and local health officials. The agency said 11 of those affected were hospitalized and no one has died. The cases occurred between November 2023 and the end of March 2024.
None of the 22 people encountered it official botulism case definition. This rare and potentially fatal disease occurs when botulinum toxin circulates in the blood and then damages the body’s nerves. The botulinum toxin used in medical treatments and cosmetic procedures, known as Botox, causes botulism very rarely, but it is possible.
Several of the patients were still given the antitoxin that treats botulism, just in case, because the side effects of botox administered poorly can resemble some of the early symptoms of the condition. Such symptoms may include blurred and double vision, constipation, incontinence, shortness of breath, weakness and difficulty holding up one’s head.
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The initial reports of these Botox injections gone wrong came out earlier this month, with Tennessee and Illinois report cases of botulism-like disease. New York later issued similar reports.
After research, the FDA issued a warning that “unsafe counterfeit versions of Botox” had been found in several states and were allegedly being used for cosmetic procedures. The agency included photos of some of the counterfeit products in its statement. “The products appear to have been purchased from unlicensed sources,” the FDA noted.
The pharmaceutical company AbbVie makes FDA-approved Botox sold in the US, and the name of the company or its offshoot Allergan Aesthetics usually appears on the packaging. The FDA has found no evidence that AbbVie’s approved Botox has been implicated in the recent illnesses, so the genuine product is still safe to obtain from licensed professionals.
The FDA did not note exactly what differed between counterfeit products and the real deal, but said that products from unlicensed sources may be “misbranded, adulterated, fake, contaminated, improperly stored and transported [or] ineffective.” Dr. Grigoris Grecopast president of the American Society of Plastic Surgeons, he told NPR he suspects that unlicensed providers buy the fakes to cut costs and that these fakes may be highly concentrated, which will increase the risk of side effects.
From April 23, diseases associated with the outbreak they have been reported in California, Colorado, Florida, Illinois, Kentucky, Nebraska, New Jersey, Tennessee, Texas, Washington, and New York. All the people affected were women and ranged in age from 25 to 59. All reported receiving Botox injections from unlicensed or untrained individuals or in non-health care settings such as spas.
Most people’s symptoms appeared within three days of the injection, although some people began to experience symptoms the same day or weeks later. Some symptoms affected the area immediately around the injection site – for example, people who injected the face experienced drooping eyelids and blurred vision. Other symptoms included dry mouth, slurred speech, shortness of breath, fatigue and generalized weakness.
The CDC recommends going to the emergency room right away if you have possible symptoms of botulism. If a doctor suspects that a person may have the condition, it is recommended to administer the antitoxin as soon as possible, without waiting for the results of laboratory tests. Early treatment can prevent the toxin from doing more harm, especially to the nerves that support breathing.
The FDA also urges healthcare providers and consumers to report any side effects associated with Botox injections MedWatch, the FDA’s safety information and adverse event reporting program. The agency’s investigation into the counterfeit products is ongoing.
This article is for informational purposes only and is not intended to offer medical advice.
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