March 29, 2024


The FDA has issued a warning to consumers against using certain topical pain relief products marketed for use before, during, or after cosmetic procedures due to potential health risks. These products contain high concentrations of lidocaine, which can lead to serious side effects including irregular heartbeat, seizures, and breathing difficulties. Despite previous warnings, these products are still available online and in stores. The FDA has issued warning letters to six companies for marketing these products illegally. Consumers are advised not to use products with more than 4% lidocaine, apply them heavily over large areas of skin, or cover treated skin with plastic wrap or dressings. Adverse events should be reported to the FDA’s MedWatch program. The FDA has given the companies 15 days to address the issues raised in the warning letters, and failure to do so may result in legal action, including product seizure.