FDA Warns Against Six Companies Selling Unapproved Lidocaine Topicals Amid Risk of Serious Side Effects

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

The U.S. Food and Drug Administration (FDA) has issued warning letters to six companies for selling unapproved and misbranded topical pain-relief products containing lidocaine, a local anesthetic. These products pose risks to consumers due to their excessive lidocaine content, which can lead to serious side effects such as irregular heartbeat, seizures, and breathing difficulties when used on large areas of skin or irritated skin.

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

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