FDA warning: unapproved topical analgesics potentially dangerous

Editor's Note

The US Food and Drug Administration (FDA) advises consumers to avoid topical analgesics marketed in violation of federal law by six different companies, including:

• TKTX Company: TKTX Numb Maximum Strength Pain Reliever, Mithra+ 10% Lidocaine, TKTX During Procedure Numbing Gel 40% and J-CAIN cream [LIDOCAINE] 29.9%
• SeeNext Venture, Ltd.: NumbSkin 5% Lidocaine Numbing Cream (15 grams), NumbSkin 5% Lidocaine Numbing Cream (30 grams) and NumbSkin 10.56% Lidocaine Numbing Cream
• Tattoo Numbing Cream Co.: Signature Tattoo Numbing Cream and Miracle Numb Spray
• Sky Bank Media, LLC, doing business as Painless Tattoo Co.: Painless Tattoo Numbing Cream and Painless Tattoo Numbing Spray
• Dermal Source, Inc.: New & Improved Blue Gel, Superior Super Juice, Premium Pro Plus, Five-Star Vasocaine and Maximum Zone 1
• Indelicare, doing business as INKEEZE: Ink Eeze Original B Numb Numbing Gel, Ink Eeze B Numb Numbing Spray Black Label and Ink Eeze B Numb Numbing Foam Soap

The FDA has issued warning letters to all six manufacturers. According to agency’s March 26 announcement, some of these products contain ingredients in higher-than-permitted concentrations, creating health risks. For example, lidocaine can cause irregular heartbeat, seizures, and breathing difficulties. Products may also interact with medication or dietary supplements.

Consumers should report any adverse events to the MedWatch Adverse Event Reporting program. Additionally, the FDA recommends avoiding products with more then 4% lidocaine; not applying OTC pain relief products heavily over large areas of skin or broken or irritated skin; and not wrapping skin treated with OTC products.