In a press release issued yesterday (here), the FDA warned six companies about topical lidocaine products that can cause serious health effects and are also unapproved new drugs.  The products are recommended for use after certain dermatological procedures “such as microdermabrasion, laser hair removal, tattooing and piercing.” 

These products are being marketed at concentrations above the OTC monograph limits and, due to their strength and the fact that they can be used on abraded skin, and possibly over a large area of the body, their use poses significant risk for severe adverse events  “such as irregular heartbeat, seizures and breathing difficulties.”  The notice indicates that the FDA has warned consumers and other companies about the danger of these types of lidocaine products over the last decade, but despite these warnings the “agency continues to find potentially dangerous products available online and in retail stores.” 

The six companies that received warning letters from the Agency are listed in the press release and the FDA is asking them to respond to the letters within 15 days.  The Agency will continue to act against unlawfully marketed products to protect consumer health. 

This issue represents another game of Whack-A-Mole that often occurs with illegally marketed products that have the potential to be associated with serious health consequences.