U.S. health regulators have issued warning letters to 18 websites accused of selling counterfeit or unapproved versions of Botox and similar wrinkle-smoothing injectable drugs, the Food and Drug Administration (FDA) announced Wednesday.
The crackdown follows reports of patient injuries, including toxic side effects, linked to these illicit products.
Botox, a purified and diluted form of botulinum toxin, is among the most potent substances known to science. It works by temporarily blocking nerve signals, causing targeted muscles to relax — a mechanism widely used for cosmetic procedures as well as medical treatments such as migraines, eye disorders, and muscle spasms.
According to the FDA, the targeted websites were primarily cosmetic product retailers offering unauthorized or mislabelled Botox-like injectables that have not undergone safety or quality review by the agency.
In the U.S., Allergan’s Botox, approved in 1989, remains the leading brand, but several FDA-approved alternatives now exist. The unapproved products, however, may contain unsafe formulations or improper concentrations of botulinum toxin.
“Patients should only receive Botox and similar injectables from licensed and trained healthcare professionals,” the FDA warned in its statement.
FDA-approved Botox products include a boxed warning — the agency’s most serious alert — cautioning that the toxin can sometimes spread beyond the injection site, potentially paralyzing muscles essential for breathing and swallowing.
Symptoms of botulism, the potentially deadly condition caused by botulinum toxin, may include slurred speech, difficulty swallowing or breathing, and muscle weakness. These signs can appear hours after injection, the agency said.
The FDA urged anyone who develops such symptoms after treatment to seek immediate medical attention.
The warning comes amid global concern over improper use of injectable cosmetic drugs. Recently, dozens of people in northeast England reported botulism-like symptoms after receiving Botox injections, underscoring the dangers of unregulated cosmetic procedures.
