FDA Issues Warning Letters to Six Companies for Selling Unapproved Lidocaine-Based Topical Pain Relief Products: Protect Your Health During Cosmetic Procedures

FDA cautions that widely used pain-relief creams could present serious health hazards

The US Food and Drug Administration (FDA) has issued warning letters to six companies for selling unapproved and misbranded topical pain-relief products with excessive lidocaine concentrations. Lidocaine, a local anesthetic, is a cause of concern as it can lead to serious side effects such as irregular heartbeat, seizures, and breathing difficulties when used on large areas of skin or irritated skin.

To prevent adverse effects, the FDA recommends avoiding products containing more than 4% lidocaine, refraining from usage on large areas of skin, and avoiding wrapping the product with dressings or plastic wraps. Some of the products cited by the FDA in their warning include TKTX Numb Maximum Strength Pain Reliever, NumbSkin Lidocaine Numbing Creams, and Signature Tattoo Numbing Cream.

Jill Furman, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research, emphasized the risks associated with these products and stated that they should not be on the market due to their potential harm to consumers. It is crucial to heed these warnings while undergoing cosmetic procedures to protect your health and well-being. For more detailed information on specific products mentioned in the FDA’s warning, interested individuals can refer to their official press release.

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