Counterfeit Botox Injections Linked to Harmful Reactions, CDC Warns
The Centers for Disease Control and Prevention (CDC) has issued an advisory regarding the risks associated with counterfeit or mishandled Botox injections. Following reports of harmful reactions in various states, the CDC, along with the U.S. Food and Drug Administration (FDA) and state and local health officials, is investigating clusters of at least 22 women who experienced adverse effects after receiving Botox injections.
The incidents have been reported in California, Colorado, Florida, Illinois, Kentucky, Nebraska, New Jersey, New York City, Tennessee, Texas, and Washington. Of the affected individuals, 11 were hospitalized, although none have died. The patients, ranging in age from 25 to 59, reported symptoms between November and March, primarily for cosmetic purposes (91%). Blurred vision, drooping eyelids, dry mouth, slurred speech, shortness of breath, fatigue, and weakness were among the symptoms experienced.
Investigations suggest a connection between these incidents and products sourced from unlicensed outlets and administered by either unlicensed or licensed providers. The FDA has previously warned healthcare professionals of the risks associated with purchasing and administering counterfeit products, as it jeopardizes patient safety.
The FDA has identified potential counterfeit Botox products with the lot number C3709C3 on the outer carton and vial. Other indicators include the listing of the active ingredient as “Botulinum Toxin Type A” rather than “OnabotulinumtoxinA,” a dosage indication of 150 units (not produced by AbbVie or Allergan), and non-English language on the packaging.
The CDC advisory emphasizes the potential adverse effects of botulinum toxin (Botox) when it diffuses beyond the injection site. Clinicians are advised to consider the possibility of adverse effects from botulinum toxin injections in patients presenting with localized paralysis and contact their respective health departments if botulism is suspected.
Botulism, a serious illness caused by botulinum toxin circulating in the bloodstream, can be treated with an antitoxin. Seeking prompt medical attention is crucial to prevent progression to paralysis and other complications.
The CDC strongly recommends that botulinum toxin be administered solely by licensed providers, using only recommended doses of FDA-approved products, preferably in licensed or accredited healthcare settings. Providers should possess proper training and adhere to state and local regulations.
In response to the counterfeit Botox reports, AbbVie and Allergan Aesthetics, the companies behind the FDA-approved versions, have affirmed that they are the exclusive authorized suppliers of Botox in the United States. They maintain a comprehensive supply chain security program to ensure the safety and security of all manufactured products distributed through authorized channels.
Consumers and providers can identify genuine Botox products by the tamper-evident seal on the packaging, the presence of the name “onabotulinumtoxinA” under the brand name Botox, and a hologram of the word “Allergan” on the vial label.
Botox is commonly used to treat both medical and cosmetic concerns in small doses. It is effective in managing severe underarm sweating, chronic migraines, overactive bladder, and facial wrinkles. Dr. Michael Cameron, president and founder of Cameron Dermatology, emphasizes the importance of seeking treatment from board-certified specialists, such as dermatologists for wrinkles, neurologists for migraines, and urologists for bladder issues.
He advises against seeking treatment based solely on price or risk concerns and encourages individuals to request the vial for inspection if necessary.
The CDC advisory underscores the need for vigilance in preventing the distribution and use of counterfeit Botox products and the importance of seeking professional medical care for Botox injections to ensure patient safety and the efficacy of treatment.
