Clinical relevance: The FDA has issued consumer warnings regarding certain over-the-counter topical pain relievers.

These warnings pertain to 19 pain relievers marketed by six companies, containing ingredients like lidocaine at levels higher than allowed by law. High lidocaine levels could lead to serious health risks such as irregular heartbeat, seizures, and breathing difficulties. Consumers are advised not to use OTC pain relief products with more than 4% lidocaine, apply them heavily over large areas of skin, or wrap treated skin with plastic wrap.

The U.S. Food and Drug Administration (FDA)  has fired off a warning to consumers about a handful of over-the-counter topical pain relievers. Regulators also issued a warning to each of the six companies that market the 19 pain relievers.

Consumers take these analgesics ahead of, or as a treatment for, some cosmetic procedures, such as microdermabrasion, laser hair removal, tattooing, and piercing.

What’s Wrong With Them?

According to the FDA, some of these pain relievers have ingredients – such as lidocaine – at much higher levels than the laws allow for OTC topical pain relievers. And that’s because topicals with these lidocaine levels, “could lead to increased absorption of the drug product through the skin, it may lead to serious injuries such as irregular heartbeat, seizures, and breathing difficulties.”

Worse still, these topicals can interact badly with other medications or even dietary supplements.

“These products pose unacceptable risks to consumers and should not be on the market,” said Jill Furman,  director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research, said in a press release. “We are committed to using all available tools to stop the sale of these illegal high-risk products.”

Part of a Larger Trend

Despite earlier FDA warnings about similar products – dating back to 2009 – regulators are still coming across these products online and in retail outlets. In fact, the FDA has insisted that it doesn’t have any evidence that back up the safety of these topicals.

The agency also warned consumers that when someone applies lidocaine over a large patch of skin, and leave it, it can lead to a serious injury.

The FDA advised consumers to:

not use OTC pain relief products with more than 4% lidocaine on their skin. not apply OTC pain relief products heavily over large areas of skin or to irritated or broken skin. not wrap skin treated with OTC pain relief products with plastic wrap or other dressings. Wrapping or covering treated skin with any type of material can increase the chance of serious side effects. FDA IDs the Players

Finally, the FDA revealed that the companies that received the warning letters were: 

TKTX Co.: 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.

Specifically, the agency told the companies they had to respond within 15 days. None of the companies have responded publicly.

Additionally, the FDA’s already put some of these companies on import alert.

Further Reading

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