The agency sent warning letters to TKTX Co., SeeNext Venture, Tattoo Numbing Cream, Painless Tattoo, Dermal Source and INKEEZE, saying their numbing products contain concentrations of lidocaine higher than what is permitted in over-the-counter topical pain relief products, which poses health risks.
“When these products that contain high concentrations of lidocaine intended to be used before or during certain cosmetic procedures are applied in ways that could lead to increased absorption of the drug product through the skin, it may lead to serious injury such as irregular heartbeat, seizures and breathing difficulties,” the agency said, noting it has received reports of adverse events related to the products.
Consumers should avoid using over-the-counter pain relief products that contain lidocaine concentrations higher than 4%, the FDA said. Additionally, people should avoid applying topical pain products heavily on large areas, especially on irritated or broken skin.
Companies that received warning letters were given 15 days to respond. The FDA said legal actions, such as product seizure and court orders that would require the companies to stop making and distributing products, may be taken if violations are not promptly addressed.
“These products pose unacceptable risks to consumers and should not be on the market,” Jill Furman, director of the office of compliance in the FDA’s Center for Drug Evaluation and Research, said in a March 26 statement. “We are committed to using all available tools to stop the sale of these illegal high-risk products.”
At the Becker's 11th Annual IT + Revenue Cycle Conference: The Future of AI & Digital Health, taking place September 14–17 in Chicago, healthcare executives and digital leaders from across the country will come together to explore how AI, interoperability, cybersecurity, and revenue cycle innovation are transforming care delivery, strengthening financial performance, and driving the next era of digital health. Apply for complimentary registration now.