Medical Professionals Reference (MPR)FDA Says Certain OTC Topical Analgesics Pose Health Risk

Elevated Lidocaine Levels in OTC Analgesics: A Closer Look at Consumer Safety and Regulatory Actions

In a recent announcement, the Food and Drug Administration (FDA) has raised concerns regarding the safety of over-the-counter (OTC) topical analgesics, particularly those exceeding 4% lidocaine concentration. Targeting six companies for marketing unapproved and potentially harmful products, the FDA’s warning underscores the critical need for adherence to established safety guidelines to protect consumers from severe health risks.

Key Points:

• The FDA has issued warning letters to six companies for selling unapproved and misbranded OTC analgesic products containing lidocaine in concentrations exceeding the recommended 4% threshold.
• These products are marketed for pain relief associated with cosmetic procedures like microdermabrasion, laser hair removal, and tattooing.
• The highlighted products include brands like TKTX, SeeNext Venture, Tattoo Numbing Cream Co., Painless Tattoo Co., Dermal Source, and INKEEZE, with some products containing lidocaine levels as high as 40%.
• High concentrations of lidocaine can lead to severe health risks, including irregular heartbeat, seizures, and breathing difficulties.
• Consumers are advised against using these high-concentration lidocaine products, especially over large skin areas or on irritated/broken skin, and to avoid wrapping treated skin areas with dressings.
• The FDA’s action reflects a commitment to safeguarding consumer health by eliminating the market presence of these high-risk products.

“These products pose unacceptable risks to consumers and should not be on the market.”
– Jill Furman, JD, Director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research

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