Six companies receive warning letters as the FDA addresses unsafe topical analgesics and urges consumer vigilance.
The U.S. Food and Drug Administration (FDA) has cautioned against using specific over-the-counter pain relief products for topical application before, during, or after cosmetic procedures like microdermabrasion or tattooing. The agency sent warning letters to six companies for marketing these products despite federal regulations.
The lidocaine levels in some of the products bear the risk of serious side effects when absorbed through the skin, especially if interacting with other medications. Potentially harmful products continue to be offered online and in stores, prompting the FDA to take action against their sale.
“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. “We are committed to using all available tools to stop the sale of these illegal high-risk products.”
Consumers are advised to avoid OTC pain relief with over 4% lidocaine, extensive skin application, or covering with materials like plastic wrap. The FDA urges the reporting of adverse events.
As the Lord Leads, Pray with Us…
- For Commissioner Robert Califf to be led by God as he oversees the FDA.
- For FDA officials as they seek to eliminate the sale and use of harmful products in the U.S.
Sources: Food and Drug Administration
