U.S. health regulators have issued warnings to 18 websites selling counterfeit or unapproved Botox and similar injectable drugs used for cosmetic purposes. The Food and Drug Administration (FDA) announced the action Wednesday, citing reports of injuries and toxic side effects linked to these products.
Reports of unsafe products and Unapproved Botox
The FDA said the warning letters were sent after receiving complaints involving counterfeit or unapproved Botox-like drugs. These products, often marketed on cosmetic websites, have not been reviewed or approved by the agency. The FDA emphasized that using unapproved injectables poses serious health risks, including potential poisoning from unsafe formulations.
Botox, a purified form of botulinum toxin, works by temporarily blocking nerve signals to relax muscles. While commonly used to reduce facial wrinkles, the FDA has also approved it for medical conditions such as muscle spasms, migraines, and eye disorders. The agency first approved Allergan’s original Botox in 1989, and several competing versions have since been cleared for use.
Serious side effects and safety warning
FDA-approved Botox products carry a boxed warning — the agency’s most serious alert — indicating the potential for life-threatening side effects. In rare cases, the toxin can spread beyond the injection site, causing paralysis or weakness in muscles that control breathing and swallowing. Symptoms such as slurred speech, difficulty breathing, and muscle weakness may appear several hours after an injection.
In its statement, the FDA urged consumers to obtain injectable treatments only from licensed medical professionals trained in their proper use. “Patients experiencing signs of botulism should seek immediate medical care,” the agency said.
The FDA continues to monitor online sales of unapproved Botox-like drugs and warned that unapproved versions may contain unknown or harmful ingredients. The agency said enforcement actions will continue to ensure consumer safety and protect the integrity of approved medical products.
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