FDA issues warning for OTC topical pain relievers with high levels of lidocaine
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Key takeaways:
- The FDA has issued warnings to six companies for the marketing of analgesics with unlawful lidocaine concentrations.
- The FDA cautions consumers to avoid these products as they may cause serious injury.
The FDA has warned consumers to avoid certain over-the-counter pain relief topicals that are used before, during or after cosmetic procedures due to potential safety risks, according to a press release.
The FDA has found that certain marketed analgesic products contain ingredients, such as lidocaine, at concentration levels that exceed the limitations for OTC pain relief topicals. When high concentrations of lidocaine are applied in ways that increase absorption, dangerous side effects can occur including irregular heartbeat, seizures and breathing difficulties. The products may also negatively interact with consumers’ medications or dietary supplements.
The FDA has sent warning letters to six companies for marketing these products in violation of federal law. Some indications for which these products are labeled include pain relief before, during or after microdermabrasion; laser hair removal; tattooing; and piercing.
“These products pose unacceptable risks to consumers and should not be on the market,” Jill Furman, JD, director of the office of compliance in the FDA’s Center for Drug Evaluation and Research, said in the release. “We are committed to using all available tools to stop the sale of these illegal high-risk products.”
The FDA has also warned consumers that applying lidocaine over large areas of skin for prolonged periods of time may cause serious injury. This risk only increases if the skin is irritated, broken or covered.
The current companies and products that have received warning letters include:
TKTX Company for 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. for 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. for Signature Tattoo Numbing Cream and Miracle Numb Spray;
Sky Bank Media LLC (Painless Tattoo Co.) for Painless Tattoo Numbing Cream and Painless Tattoo Numbing Spray;
Dermal Source Inc. for New & Improved Blue Gel, Superior Super Juice, Premium Pro Plus, Five-Star Vasocaine and Maximum Zone 1; and
Indelicare (INKEEZE) for 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 encourages consumers to take necessary precautions including stopping all use of OTC pain relief products that contain more than 4% lidocaine. If consumers do use OTC analgesics, they should not apply it heavily over large areas of skin, especially broken or irritated skin. Wrapping plastic wrap or any other covering over skin that is treated with these products should also be avoided as this increases risk of serious injury.
The companies have 15 days to respond to the warning letters with a receipt outlining how they will address these issues or why they think the products are lawful. In the meantime, the FDA has placed import alerts on some of these companies in an effort to stop their products from reaching consumers.
Perspective
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OTC pain relief products containing lidocaine, a local anesthetic, offer significant benefits in numbing localized pain. However, it’s critical for consumers to use these products responsibly due to potential risks associated with improper usage. Here’s why certain precautions are necessary:
First, consumers should not use OTC products with more than 4% lidocaine on the skin. Lidocaine concentrations higher than 4% increase the risk of systemic absorption, which can lead to lidocaine toxicity. The body absorbs higher concentrations more readily, which can quickly lead to toxic blood levels, especially if applied over large areas or used frequently. Symptoms of toxicity may include dizziness, tremors, seizures, respiratory distress or even cardiac arrest in severe cases.
Second, consumers should not apply OTC pain relief products heavily over large areas or to irritated or broken skin. Applying lidocaine heavily or over extensive skin areas can cause excessive absorption into the bloodstream, raising the risk of toxicity. Similarly, irritated or broken skin has a higher absorption rate, again increasing the likelihood of adverse effects. It’s essential to limit the use to small, targeted areas and intact skin to minimize these risks.
Third, consumers should not wrap skin treated with OTC pain relief products with plastic wrap or other dressings. Covering treated areas with plastic wrap or similar materials creates a warm and moist environment that enhances the absorption of lidocaine through the skin. This occlusion can dramatically increase the amount of lidocaine entering the bloodstream, leading to an elevated risk of toxicity. Always allow the skin to breathe after applying lidocaine products to prevent excessive absorption.
Overall, while topical lidocaine is generally safe when used as directed, misuse can lead to serious health risks due to lidocaine toxicity. Early symptoms might include numbness of the lips and tongue, dizziness, tinnitus and visual disturbances. If exposure continues, it can progress to more severe symptoms such as convulsions, cardiac dysrhythmias, and in extreme cases, cardiac arrest.
Long-term misuse or overuse of lidocaine can also affect the heart and nervous system, potentially leading to life-threatening conditions. People with liver problems are at a higher risk since lidocaine is metabolized in the liver; reduced liver function can slow the processing of lidocaine, increasing the risk of accumulation and toxicity.
It’s crucial to follow product instructions carefully, including the maximum amount to be applied and the frequency of application. Consulting a health care provider before using new OTC pain relief products containing lidocaine is always a good practice, especially for individuals with pre-existing health conditions or those taking other medications that might interact with lidocaine.
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