WASHINGTON - The U.S. Food and Drug Administration (FDA) has issued a warning for consumers to steer clear of certain over-the-counter (OTC) topical analgesics that are being sold for pain relief associated with various cosmetic procedures.
The warning, which was released today, specifically targets products marketed for use before, during, or after procedures such as microdermabrasion, laser hair removal, tattooing, and piercing.
The regulatory agency has identified products containing lidocaine in concentrations exceeding the approved limits for OTC use. High levels of lidocaine can potentially cause severe health issues, including irregular heartbeat, seizures, and breathing difficulties, especially when applied to large skin areas or on irritated or broken skin, or when skin is covered after application. These products could also interact with other medications or dietary supplements.
Jill Furman, J.D., director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research, expressed the agency's position, stating, “These products pose unacceptable risks to consumers and should not be on the market.” The FDA has taken action by issuing warning letters to six companies for marketing unapproved and misbranded products, which is a violation of federal law.
Companies that received warning letters include TKTX Company, SeeNext Venture, Ltd., Tattoo Numbing Cream Co., Sky Bank Media, LLC (doing business as Painless Tattoo Co.), Dermal Source, Inc., and Indelicare (doing business as INKEEZE).
The FDA has requested these companies to respond within 15 days with plans to correct the violations or to justify why they believe their products are compliant with the law. Non-compliance could lead to further legal actions, such as product seizures or court-ordered manufacturing and distribution halts. Some companies have also been placed on an import alert to prevent their products from entering the United States.
The FDA advises consumers not to use OTC pain relief products with more than 4% lidocaine on their skin, avoid applying them to large areas or damaged skin, and not to cover treated skin with any type of material, which can increase the risk of serious side effects.
The agency is monitoring adverse event reports related to these products and encourages health care professionals and consumers to report any negative effects through the MedWatch Adverse Event Reporting program.
This action is part of the FDA's commitment to safeguarding public health by ensuring the availability of safe and effective products. The information for this article is based on a press release statement from the FDA.
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