FDA Issues Warning Against High-Lidocaine Pain Relief Products

In a significant public health announcement, the U.S. Food and Drug Administration (FDA) has issued a warning to consumers advising against the use of certain over-the-counter analgesic products intended for topical use. These products, which are marketed primarily for pain relief in cosmetic procedures such as microdermabrasion, laser hair removal, tattooing, and piercing, may pose serious health risks. FDA News Release

High Risk with High Lidocaine

The FDA’s warning focuses on products containing lidocaine in concentrations higher than what is allowed for over-the-counter sales. Lidocaine, a local anesthetic, when used in high doses or over large areas, especially on irritated or broken skin, can lead to severe side effects. These include irregular heartbeat, seizures, and breathing difficulties, particularly when the skin is covered after application, which increases absorption.

Companies and Products Under Scrutiny

The FDA has issued warning letters to six companies accused of marketing these unapproved and misbranded products. The products cited in the FDA’s warning include:

• TKTX Company:

  • TKTX Numb Maximum Strength Pain Reliever

  • Mithra+ 10% Lidocaine

  • TKTX During Procedure Numbing Gel 40%

  • J-CAIN cream [LIDOCAINE] 29.9%

• SeeNext Venture, Ltd.:

  • NumbSkin 5% Lidocaine Numbing Cream (15 grams)

  • NumbSkin 5% Lidocaine Numbing Cream (30 grams)

  • NumbSkin 10.56% Lidocaine Numbing Cream

• Tattoo Numbing Cream Co

  • Signature Tattoo Numbing Cream

  • Miracle Numb Spray

• Sky Bank Media, LLC, doing business as Painless Tattoo Co.:

  • Painless Tattoo Numbing Cream

  • Painless Tattoo Numbing Spray

• Dermal Source, Inc.:

  • New & Improved Blue Gel

  • Superior Super Juice

  • Premium Pro Plus

  • Five-Star Vasocaine

  • Maximum Zone 1

• Indelicare, doing business as INKEEZE:

  • Ink Eeze Original B Numb Numbing Gel

  • Ink Eeze B Numb Numbing Spray Black Label

  • Ink Eeze B Numb Numbing Foam Soap

Safety Recommendations

The FDA strongly advises consumers not to use OTC pain relief products with more than 4% lidocaine. Additionally, these products should not be applied heavily over large areas of skin or to irritated or broken skin. Covering the treated skin with plastic wrap or other dressings can significantly increase the chance of serious side effects.

Reporting and Compliance

The agency encourages both consumers and healthcare professionals to report any adverse events related to these products through the FDA’s MedWatch Adverse Event Reporting program. This will enable the FDA to take appropriate actions to protect the public from unsafe products.

The implicated companies have been asked to respond to the warning letters within 15 days, detailing how they will address the issues raised or providing reasoning as to why they believe their products do not violate federal law. Non-compliance could result in legal action, including product seizure and a court order to cease manufacturing and distribution.

FDA’s Ongoing Role

As an agency within the U.S. Department of Health and Human Services, the FDA remains committed to ensuring the safety, effectiveness, and security of various consumer products, including drugs and medical devices. This recent action underscores the agency’s dedication to upholding health standards and safeguarding public health.

For more information and updates on this issue, please visit the FDA’s official website or consult your healthcare provider before using any pain relief products.