Washington, DC: Further to reports of burns, pain and skin damage, the U.S. Food and Drug Administration (FDA) has issued a public alert concerning certain over-the-counter (OTC) products that are applied to the skin for the relief of mild muscle and joint pain. These OTC topical muscle and joint pain relievers have been reported to cause rare cases of serious skin injuries, ranging from first- to third-degree chemical burns, where the products were applied.
These OTC topical muscle and joint pain relievers are available as single- or combination-ingredient products that contain menthol, methyl salicylate, or capsaicin. The various formulations include creams, lotions, ointments, and patches.
Marketed under various brand-names, include Bengay, Capzasin, Flexall, Icy Hot, and Mentholatum.
When applied to the skin, the products produce a local sensation of warmth or coolness; they should not cause pain or skin damage. However, there have been rare cases of serious burns following their use (see Data Summary below). Some of the burns had serious complications requiring hospitalization. In many cases, the burns occurred after only one application of the OTC topical muscle and joint pain reliever, with severe burning or blistering occurring within 24 hours of the first application. Based on the reported cases, the majority of second- and third-degree burns occurred with the use of products containing menthol as the single active ingredient, and products containing both menthol and methyl salicylate, in concentrations greater than 3% menthol and 10% methyl salicylate. Few cases reported using a capsaicin-containing product.
Consumers using an OTC topical muscle and joint pain reliever who experience signs of skin injury where the product was applied, such as pain, swelling, or blistering of the skin, should stop using the product and seek medical attention immediately, the FDA states.
Rare cases of serious burns have been reported to occur on the skin where over-the-counter (OTC) topical muscle and joint pain relievers were applied. These products contain the active ingredients menthol, methyl salicylate, or capsaicin.
Of the burns that have been reported, the majority of second- and third-degree burns occurred with products containing menthol as the single active ingredient and products containing both menthol and methyl salicylate, at concentrations greater than 3% menthol and 10% methyl salicylate. Few cases reported using a capsaicin-containing product. Some of the burns had serious complications requiring hospitalization.
The skin injuries described were recently assessed by FDA. Existing Tentative Final Monograph does not at this time require labels of OTC topical muscle and joint pain relievers to carry a warning that use of the products could result in serious burns.
Data Summary
A search of FDA' Adverse Event Reporting System (AERS) database (from 1969 through April 21, 2011), the National Electronic Injury Surveillance System ??" Cooperative Adverse Drug Event Surveillance (NEISS-CADES) database (from 2004 to 2010), and the medical literature1 identified 43 cases of burns on the application site associated with the use of over-the-counter (OTC) topical muscle and joint pain relievers containing the active ingredients menthol, methyl salicylate, or capsaicin.
The products associated with these cases include patches, balms, and creams. All cases in this series include burns that were confirmed by a health care professional. In the case series, there were reports of burns ranging from first-degree to third-degree, but many cases did not specify the degree of the burn.
Many cases occurred following one application of the OTC topical muscle and joint pain reliever, with severe burning or blistering occurring within 24 hours of the first application of the product. A majority of the second- and third-degree burns were reported with the use of products containing menthol as the single active ingredient or products containing both menthol and methyl salicylate, where the concentration of the ingredients was greater than 3% menthol and 10% methyl salicylate. Few cases reported using a capsaicin-containing product.
