Some topical pain relief products may cause dangerous health effects, FDA warns
FILE - An artist tattoos someone's arm.
Certain topical pain relief products could potentially lead to dangerous health effects, according to the U.S. Food and Drug Administration.
In a warning issued by the agency on March 26, some over-the-counter analgesic (pain relief) products that are often used for certain cosmetic procedures such as microdermabrasion, laser hair removal, tattooing and piercing could potentially lead to serious injury.
Some topical pain relief products contain higher concentrations of lidocaine which can lead to increased absorption of the product through the skin, the FDA explained. This can increase the risk of some dangerous health impacts such as irregular heartbeat, seizures and difficulty breathing.
"These products pose unacceptable risks to consumers and should not be on the market," said Jill Furman, J.D., director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. "We are committed to using all available tools to stop the sale of these illegal high-risk products."
The FDA sent warning letters to the following companies whose products could pose a potential health risk:
- 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: Inke Eeeze Original B Numb Numbing Gel, Ink Eze B Numb Numbing Spray Black Label and Ink Eeze B Numb Numbing Foam Soap
The FDA recommends that consumers shouldn’t use OTC pain relief products that contain more than 4% lidocaine on their skin and not spread the product heavily over a large area of skin that is irritated or broken.
It is also not recommended to wrap skin that has been treated with OTC pain relief products that have high concentrations of pain relief ingredients with plastic wrap or other dressings.
"Wrapping or covering treated skin with any type of material can increase the chance of serious side effects," the FDA said.
Companies who were sent a warning letter have 15 days to respond to the FDA with their plans on how to address the issues or provide reasons that support why their products are not violating the law.
This story was reported from Los Angeles.