The Food and Drug Administration issued a warning Thursday after some consumers reported serious skin injuries while using certain over-the-counter (OTC) pain relievers applied to the skin to relieve mild muscle and joint pain.
OTC topical pain relievers for muscles and joints include creams, lotions, ointments and patches. In many cases, burns occurred after just one application, with severe burning or blistering occurring within 24 hours. Some users had complications serious enough to require hospitalization.
The injuries, while rare, have ranged from mild to severe chemical burns with use of such brand-name topical muscle and joint pain relievers as Icy Hot, Bengay, Capzasin, Flexall, and Mentholatum.
"There's no way to predict who will have this kind of reaction to a topical pain reliever for muscles and joints," says Jane Filie, M.D., a medical officer in FDA's Division of Nonprescription Regulation Development.
According to FDA data, there have been 43 reported cases of burns associated with the use of OTC topical muscle and joint pain relievers containing the active ingredients menthol, methyl salicylate and capsaicin.
Menthol, methyl salicylate and capsaicin create sensations of warmth or coolness, but should not burn.
A majority of the more severe burns occurred when consumers used a menthol or menthol/methyl salicylate combination product. Most of these cases involved products that contain higher concentrations of menthol and methyl salicylate (greater than 3 percent menthol or 10 percent methyl salicylate). Few of the cases involved capsaicin, alone.
With today's warning, the FDA offered the following advice for consumers using OTC topical muscle and joint pain relievers:
• Don't apply these products onto damaged or irritated skin.
• Don't apply bandages to the area where you've applied a topical muscle and joint pain reliever.
• Don't apply heat to the area in the form of heating pads, hot water bottles or lamps. Doing so increases the risk of serious burns.
• Don't allow these products to come in contact with eyes and mucous membranes (such as the skin inside your nose, mouth or genitals).
• It's normal for these products to produce a warming or cooling sensation where you've applied them. But if you feel actual pain after applying them, look for signs of blistering or burning. If you see any of these signs, stop using the product and seek medical attention.
• If you have any concerns about using one of these products, talk to a medical professional first.
• Report unexpected side effects from the use of OTC topical pain reliever to the FDA MedWatch program