U.S. FDA Warns That High-Strength Lidocaine Skin Creams Can Trigger Seizures, Arrhythmia And Breathing Issues!
Nikhil Prasad Fact checked by:Thailand Medical News Team Apr 28, 2024 6 months, 2 days, 2 hours, 59 minutes ago
Medical News: In recent news, the U.S. Food and Drug Administration (FDA) has issued warnings regarding high-strength lidocaine skin creams, highlighting potential risks such as seizures, arrhythmia, and breathing issues. This cautionary stance comes as certain pain-relieving skin products contain alarming doses of lidocaine, prompting the FDA to take action to protect consumers.
U.S. FDA Warns That High-Strength Lidocaine Skin Creams Can Trigger
Seizures, Arrhythmia And Breathing Issues
The Concern with High-Strength Lidocaine in Skin Products
Lidocaine is a common numbing agent used in various medical and cosmetic procedures to alleviate pain. It is also used in various tattoo parlors and during illegal administered intravenous doses of antioxidants, glutathione and other skin whitening products. However, the U.S.FDA's concern arises when lidocaine concentrations exceed 4% in topical products. These high-strength formulations can pose significant health risks, especially when applied over large areas of skin or on irritated or broken skin.
FDA's Warning Letters and Companies Identified
The FDA has issued warning letters to six companies found marketing products containing excessive lidocaine concentrations. These companies and their products include:
-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
Risks Associated with High Concentrations of Lidocaine
The FDA emphasizes that lidocaine concentrations above 4% in topical products can lead to severe health complications. These include irregular heartbeat, seizures, breathing difficulties, and potential interactions with other medications or supplements. Such risks are heightened when these products are used in conjunction with cosmetic procedures that may facilitate greater skin absorption.
According to certain
Medical News reports, there has been a number of cases registered across ER depts at various hospitals a
cross the United States linking emergency medical incidences to the usage of these high-strength lidocaine creams.
FDA's Recommendations for Consumers
In light of these concerns, the FDA advises consumers to:
-Avoid using over-the-counter (OTC) pain relief products with lidocaine concentrations exceeding 4%.
-Refrain from applying such products heavily over large areas of skin, especially on irritated or broken skin.
-Not wrap skin treated with these products in plastic wrap or other coverings, as this can increase the risk of adverse effects.
FDA's Continued Vigilance and Call for Reporting
Despite past warnings and actions, the FDA remains vigilant as potentially harmful products continue to be available online and in stores. The agency urges consumers and healthcare professionals to report any adverse events related to these products through the MedWatch Adverse Event Reporting program. This proactive approach enables the FDA to take swift measures to safeguard public health.
Response Required from Companies
The FDA has given the aforementioned companies 15 days to respond to the warning letters. Companies must outline their plans to address the identified issues or provide reasoning and evidence supporting their compliance with regulations. Failure to rectify violations promptly may lead to legal repercussions, including product seizure and injunctions against manufacturing and distribution.
https://www.fda.gov/news-events/press-announcements/fda-warns-consumers-avoid-certain-topical-pain-relief-products-due-potential-dangerous-health
Importance of Compliance and Safety
The FDA's actions underscore the critical importance of compliance with regulations governing topical pain relief products. Safety considerations are paramount, especially in the context of cosmetic procedures where skin absorption and potential interactions can pose significant health risks. By upholding safety standards and educating consumers, the FDA aims to mitigate harm and ensure the well-being of the public.
Conclusion
In conclusion, the FDA's warning regarding high-strength lidocaine skin creams serves as a vital reminder of the potential dangers associated with these products. Consumers must exercise caution, adhere to recommended guidelines, and report any adverse effects promptly. Through regulatory enforcement and public awareness, the FDA endeavors to uphold product safety and protect individuals from avoidable health risks.
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