WARNING: OVER-THE-COUNTER TOPICAL PRODUCTS FOR MUSCLE AND JOINT PAIN IN RARE CASES MAY CAUSE CHEMICAL BURNS

September 17, 2012

Here’s an important alert for patients who use over-the-counter (OTC) topical muscle and joint pain relievers containing menthol, methyl salicylate or capsaicin.

On Sept. 13, 2012, the Food and Drug Administration (FDA) issued a safety announcement to health care providers and consumers about rare cases of mild to severe chemical skin burns caused by use of OTC topical pain relievers. If you experience any pain, swelling or blistering of the skin after applying one of these products, immediately stop using the product and seek medical attention.

OTC topical pain relievers are commonly used to treat minor aches and pain involving muscles and joints. These products are available in the form of creams, ointments, lotions and patches and typically contain one or more of the following drugs: menthol, methyl salicylate and capsaicin. They are sold by several companies under such brand names as BENGAY, CAPZASIN, FLEXALL, ICY HOT and MENTHOLATUM.

The FDA disclosed that it has received reports of 43 cases of chemical burns associated with use of these products. The agency noted that in many cases, the burns occurred after just one application of the product, with severe burning or blistering occurring within 24 hours. In some cases, complications related to the burns required hospitalization of the patient.

In analyzing the reported cases, the FDA found that the most severe burns occurred with the use of 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),” the agency warned. Few of the cases involved capsaicin.

Jane Filie, M.D., a medical officer in the FDA's Division of Nonprescription Regulation Development, said, "There's no way to predict who will have this kind of reaction to a topical pain reliever for muscles and joints."

The agency emphasized that the number of reported cases of skin burns is very small when compared to the number of people who purchase these products. We note, however, that there is likely significant underreporting of these adverse events.

Read the full FDA consumer safety announcement.

What You Should Do

The use of topical pain relievers remains a reasonable and generally safe option for treating muscle and joint pain. To minimize the chances of having a chemical burn, you should avoid using products with greater than 3 percent menthol or 10 percent methyl salicylate.

The FDA offered the following additional tips for ensuring safe use of OTC topical muscle and joint pain relievers:

• Don't apply these products to damaged or irritated skin.
• Don't apply bandages to the area on which 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 your eyes or 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 pain after applying them, look for signs of blistering, swelling or burning. If you see any of these signs, immediately stop using the product and seek medical attention.
• If you have any concerns about using one of these products, talk to your primary health care provider.

Report any adverse effects related to topical pain reliever products to the FDA MedWatch program.