On March 26, 2024, the U.S. Food and Drug Administration (FDA) issued a warning for consumers to avoid certain over-the-counter (OTC) analgesic products. These products are marketed for topical use to relieve pain before, during, or after certain cosmetic procedures (for example, laser hair removal, microdermabrasion, piercing, and tattooing). Warning letters were issued to six companies marketing certain topical products that may contain lidocaine at concentrations that exceed the current permitted OTC levels for pain relief. (For more information, read the FDA news release here.)

The FDA recommends that consumers not use any OTC pain relief product that contains more than 4% lidocaine. Topical lidocaine pain relief products should not be applied over large areas of skin, to broken skin, or to irritated skin due to the risk of increased absorption. Additionally, wrapping treated areas with plastic wrap or dressings may increase the level of absorption throughout the body and should therefore be avoided. When products containing high concentrations of lidocaine are applied in ways that may increase the absorption of lidocaine through the skin, as noted above, it may lead to serious adverse effects such as seizures, irregular heartbeat, and breathing difficulties.

Impact on workers’ compensation and auto no-fault

The most recent warning addresses products used for cosmetic procedures. However, it is important to be aware of the risks associated with the improper use of any topical lidocaine product, since topical lidocaine is prescribed to aid in pain relief in many of our workers’ compensation claims. In the population in general, topical medications and OTC products are often not recognized as medications with potential side effects, yet they can have serious side effects if used inappropriately. Due to the availability of both prescription and OTC lidocaine preparations, there is an increased risk of therapeutic duplication. The fact that some prescription products contain higher concentrations of lidocaine than the OTC products further increases the concern. Topical products containing a combination of medications are common, which makes it imperative to read labels carefully and review all medications the injured person is taking.

To reduce the risk of adverse medication-related events, injured persons should be encouraged to speak to their healthcare providers (including pharmacists) before starting any new medication (whether OTC or prescription) or making changes to their current therapy.

If you have any questions, please contact your account manager, clinical liaison, or our Clinical Services team at 1-877-275-7674 ext. 8612.

Sources:

1. U.S. Food and Drug Administration. FDA News Release. FDA Warns Consumers to Avoid Certain Topical Pain Relief Products Due to Potential for Dangerous Health Effects. March 26, 2024.