The US Food and Drug Administration (FDA) warned consumers in a statement issued on March 26 to avoid certain unapproved over-the-counter topical analgesic products because of the risk for dangerous health effects.
The warning applies to products "marketed for topical use to relieve pain before, during, or after certain cosmetic procedures," including microdermabrasion, laser hair removal, tattooing, and piercing. The ingredients in some of these products, notably lidocaine, are present in concentrations higher than what is allowed by federal law.
"These products pose unacceptable risks to consumers and should not be on the market," said Jill Furman, JD, director of the Office of Compliance in the FDA's Center for Drug Evaluation and Research, said in the statement.
The FDA has identified six products of particular concern and has issued warning letters to these six companies for illegal marketing of these pain relief products:
- 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
These products and others with illegally high doses of lidocaine could cause serious injury when applied in ways that could promote increased absorption, such as use on large areas, areas covered for long periods, or on broken or irritated skin, according to the statement.
Potential serious health effects include irregular heartbeat, seizures, and breathing difficulties. The illegal high-risk products included in the warning also may interact with medications or dietary supplements, the FDA emphasized.
Potentially dangerous products remain available to consumers online and through retail stores, despite previous warnings dating back to 2009, according to the statement.
The FDA has no evidence to support the safety of these products and advises consumers not to apply over-the-counter pain relief products over large areas or on irritated or broken skin and not to cover skin treated with these products in plastic wrap or other dressings because wrapping treated skin can further increase the potential for dangerous side effects.
The FDA has asked the companies that received warning letters to respond within 15 days of receipt, according to the statement, and failure to address violations may result in legal action including seizure of products and orders to cease manufacturing them.
Import alerts also have been placed on some companies to prevent the entry of the targeted products into the United States, according to the statement.
Consumers and health care professionals should report any adverse events related to the use of over-the-counter pain relief products to the MedWatch Adverse Event Reporting program.