FDA Warns of Risks with OTC Pain Relief Products

The U.S. Food and Drug Administration (FDA) has issued a stern warning to consumers regarding the use of certain over-the-counter analgesic (pain relief) products intended for topical use before, during, or after various cosmetic procedures like microdermabrasion, laser hair removal, tattooing, and piercing.

The FDA has identified several companies marketing these products in violation of federal law and has taken decisive action to address this concern. 

Key Points from the FDA Warning: 

• High Concentrations of Lidocaine: Some of these products contain ingredients, such as lidocaine, at concentrations higher than permitted for over-the-counter topical pain relief products. When applied before or during cosmetic procedures, they can lead to increased absorption through the skin, resulting in serious health risks such as irregular heartbeat, seizures, and breathing difficulties. 
• Interaction Risks: These products may also interact with medications or dietary supplements, posing additional risks to consumers. 
• Persistent Availability: Despite previous FDA warnings, these potentially dangerous products continue to be available online and in retail stores. The FDA emphasizes that there is no evidence demonstrating the safety of these products. 

Affected Products 

The warning specifically addresses products from six companies, including TKTX Company, SeeNext Venture, Ltd., Tattoo Numbing Cream Co., Sky Bank Media LLC (Painless Tattoo Co.), Dermal Source, Inc., and Indelicare (INKEEZE). Examples of products include TKTX Numb Maximum Strength Pain Reliever and Ink Eeze Original B Numb Numbing Gel. 

Recommendations for Consumers: 

The FDA advises consumers to: 

• Avoid using over-the-counter pain relief products with more than 4% lidocaine on their skin. 
• Refrain from applying these products heavily over large areas of skin or to irritated or broken skin. 
• Avoid wrapping treated skin with plastic wrap or other dressings, as this can increase the risk of serious side effects. 

FDA Actions 

The FDA has issued warning letters to the companies involved, requiring them to respond within 15 days, outlining how they will address the issues raised or providing justification for why they believe their products are not in violation of the law.

Failure to comply may result in legal action, including product seizure and cessation of manufacturing and distribution. Some companies have also been placed on import alert to prevent their products from entering the U.S. market. 

Reporting Adverse Events 

Consumers and healthcare professionals are urged to report any adverse events related to these products to the FDA’s MedWatch Adverse Event Reporting program. This helps the FDA take swift action to protect public health. 

Conclusion 

In conclusion, the FDA’s warning underscores the importance of caution when using topical pain relief products, particularly in the context of cosmetic procedures. Consumers must remain vigilant and informed to safeguard their health and well-being.