Over-the-Counter Topical Pain Relievers May Cause Burns

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 over-the-counter (OTC) topical muscle and joint pain relievers containing menthol, methyl salicylate or capsaicin. The FDA urges consumers experiencing any pain, swelling or blistering of the skin after applying one of these products to immediately stop using the product and seek medical attention.

OTC topical pain relievers are commonly used to treat minor aches and pains involving muscles and joints. These products, available in the form of creams, ointments, lotions and patches, are sold under such brand names as BENGAY, CAPZASIN, FLEXALL, ICY HOT and MENTHOLATUM.

The number and concentration of active ingredients vary significantly among available OTC topical pain relievers, even among products sold under the same brand name. For example, see the table below for a list of the active ingredients found in a selection of BENGAY brand products.

Active Ingredients in Select BENGAY Brand Topical Pain Relievers

In analyzing the 43 reported cases of chemical burns associated with use of OTC topical pain relievers, the FDA found that the most severe burns involved a menthol or menthol/methyl salicylate combination product, particularly products containing “higher concentrations of menthol and methyl salicylate (greater than 3 percent menthol or 10 percent methyl salicylate).” Few of the cases involved products containing only capsaicin. The FDA noted that “in many cases, burns … occurred after just one application, with severe burning or blistering occurring within 24 hours. Some had complications serious enough to require hospitalization.”

Dr. Jane Filie, 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 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 adverse events.

What You Should Do

The use of topical pain relievers remains a reasonable and generally safe option for treating muscle and joint pain.

Before purchasing one of these products, review the list of active ingredients provided on the packaging. To minimize the chances of chemical burn, you should consider first using products with no more than 3 percent menthol or 10 percent methyl salicylate or those containing only capsaicin as the active ingredient. If a product with a higher concentration of menthol or methyl salicylate is needed to obtain adequate pain relief, try using the product with the next higher concentration.

The FDA offers the following additional tips:

• Do not apply topical muscle and joint pain relievers to damaged or irritated skin.
• Do not apply bandages to the area on which you’ve applied these products.
• To lessen the risk of serious burns, do not apply heat (via heating pads, lamps or hot water bottles) to the area.
• Do not allow the products to contact your eyes or mucous membranes (the skin inside your nose, mouth or genitals).
• If you feel pain (as opposed to a warm or cool sensation) after applying the products, look for signs of blistering, swelling or burning. Immediately stop using the product and seek medical attention if you see any of these signs.
• Talk to your primary health care provider about any concerns regarding the use of these products.

Report any adverse effects related to topical pain reliever products to the FDA MedWatch program online or by regular mail, fax or phone.

• Online: https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm
• Regular mail: Use postage-paid, pre-addressed FDA form 3500 and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
• Fax: (800) FDA-0178
• Phone: (800) FDA-1088

To read the full FDA consumer safety announcement, visit http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm318674.htm