Applying topical pain gels and creams on broken, irritated, or large areas of the skin for prolonged periods may result in serious injuries, the FDA warns.
Federal regulators are urging consumers to avoid using certain over-the-counter topical pain reliever products that contain high concentrations of lidocaine, due to risks that the products may interact with other medications or dietary supplements, potentially causing serious injuries, such as irregular heartbeat, seizures and breathing difficulties.
The U.S. Food and Drug Administration (FDA) issued a press release on March 26, announcing that warning letters were sent to six different companies manufacturing or distributing topical pain relieving products, indicating that some of the products have not been established as safe, contain unapproved ingredients, or were distributed with lidocaine concentrations that exceed those permitted in over-the-counter (OTC) analgesic drug products.
The pain relieving gel, cream, and spray products are marketed to be used before and during pain-sensitive cosmetic procedures, such as tattooing, piercing, microdermabrasion, laser hair removal, wart or mole removal, and hemorrhoid removal surgeries, among others. However, officials warn the products contain potentially harmful amounts lidocaine that exceed the permitted concentration range of 0.5% to 4% for those products, which may result in overdose.
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The FDA indicates applying products with high lidocaine concentrations before or during certain cosmetic procedures can lead to increased absorption of the ingredient through the skin, which can result in serious injuries.
In addition, the products may interact with other medications or dietary supplements the user is taking, the FDA warns. Some products also contain other active ingredients that are unapproved, and others include ingredients that may interact with each other, or increase the risk of harmful side effects.
Lidocaine Health Concerns
The FDA issued a public health advisory in 2009, over serious and potentially life-threatening side effects associated with certain topical anesthetic creams, gels, and ointments, including those with lidocaine.
The agency warned that applying too much of the products, applying them to large areas of the skin, applying directly on irritated or broken skin, and covering the skin with plastic or a heating pad after application could lead to excessive absorption of active ingredients. The warning came following the deaths of two women who used the skin-numbing products after laser hair removal.
Irregular heartbeat, seizures, breathing difficulties, coma and even death can occur when lidocaine is applied for long periods of time on irritated, broken, or large areas of skin, or if the skin is covered after the product is applied, the agency warns.
A similar oral lidocaine painkiller warning was issued in 2014, due to risks that the products could cause serious injuries or deaths to infants if used to relieve teething pain. At that time, the FDA ordered a black box warning, the strongest warning label the agency can require, be added to prescription oral viscous lidocaine 2% products, after becoming aware of at least 22 cases involving lidocaine toxicity. At least six of those incidents resulted in death, 11 children were hospitalized, three suffered from life-threatening injuries, and two required medical intervention.
Topical Anesthetic Product Warning Letters
The FDA cited TKTX Company for marketing and distributing unapproved TKTX Numb Maximum Strength Pain Reliever with 22% lidocaine, Mithra+ 10% Lidocaine, During Procedure Numbing Gel with 8% lidocaine, and J-CAIN cream 29.9% lidocaine products. The products contain lidocaine concentrations that well exceed levels currently permitted, and were advertised as safe for use on broken and covered skin, despite prior FDA warnings. In addition, the products also contain other active ingredients that are not approved to be combined with lidocaine, as they may increase its side effects or interact with each other.
SeeNext Venture, Ltd. Was cited for similar violations over its unapproved NumbSkin 5% Lidocaine Numbing Cream and NumbSkin 10.56% Lidocaine Numbing Cream products. The manufacturer was also cited for marketing the product as safe for use in relieving pain associated with anorectal disorders like hemorrhoids, and after certain anorectal procedures.
The warning letter to Tattoo Numbing Cream Co. indicates that its unapproved Signature Tattoo Numbing Cream and Miracle Numb Spray products contain higher lidocaine concentrations than permitted, The FDA also cited the company for marketing the products as safe for use on broken and covered skin, despite prior agency warnings. In addition, the products also contain the active ingredients prilocaine and epinephrine, which are not approved to be used together in the same product.
Sky Bank Media, LLC doing business as Painless Tattoo Cream Co. was warned of lidocaine concentrations that exceed what is permissible in its Painless Tattoo Numbing Cream and Painless Tattoo Numbing Spray products. Like the other warnings, the FDA expressed safety concerns over the intended use of the products, due to the potential for greater active ingredient absorption through irritated and broken skin. Those products also contain the active ingredients prilocaine and epinephrine, which are not approved to be combined with each other.
Dermal Source, Inc. received warning over high lidocaine concentrations in its New & Improved Blue Gel, Superior Super Juice, Premium Pro Plus, Five-Star Vasocaine, and Maximum Zone 1 products. The FDA cited the manufacturer for advertising the products as safe for use on broken skin and sensitive areas, such as the eye during permanent cosmetic tattooing. Several products include a combination of lidocaine hydrocholoride, tetracaine hydrocholoride, and benzocaine active ingredients, which are not permitted to be in the same product.
In the warning letter to Indelicare, doing business as INK EEZE, the FDA cited its Original B Numb Numbing Gel, B Numb Numbing Spray Black Label and B Numb Numbing Foam Soap for containing high concentrations of lidocaine and combining both lidocaine and lidocaine HCL active ingredients. The company also received warning for marketing certain products as safe for anorectal use, and on broken or covered skin, against prior FDA warnings.
The FDA requested the companies send notification in writing within 15 working days, describing the steps they will take to address the violations, with an explanation of each step being taken to prevent future violations.
The agency urges consumers to avoid using any OTC topical pain-relieving product with more than 4% lidocaine. The FDA recommends avoid applying large amounts of any OTC pain relief product on large areas of the skin, and on broken or irritated skin. Consumers should also avoid wrapping or covering their skin after applying the products, as this can increase the chance of serious side effects.
Officials encourage consumers to report any side effects they may have experienced to the FDA MedWatch Adverse Event Reporting Program.
Tags: Coma, Drug Overdose, Heart Rhythm, Lidocaine, Pain Management, Respiratory, Skin Cream
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