FDA Warns of Burns From Topical Pain Relievers

Emma Hitt, PhD

Disclosures

September 13, 2012

September 13, 2012 — Topical over-the-counter muscle and joint pain relievers, such as Bengay, Capzasin, Flexall, Icy Hot, and Mentholatum, may in rare instances cause serious burns, a new alert from the US Food and Drug Administration (FDA) warns.

A Drug Safety Communication from the FDA's MedWatch safety information and adverse event reporting program points out that the products have been reported to "cause rare cases of serious skin injuries, ranging from first- to third-degree chemical burns, where the products were applied."

To date, more than 43 reported cases of burns associated with the use of these products have been reported, the FDA says. "This is a very small number of cases when compared to the number of people who purchase these products," FDA chemist Reynold Tan, PhD, emphasized.

The alert notes that the products may produce a sensation of warmth or coolness when applied to the skin, but they should not burn. "These products should not cause pain or skin damage; however, there have been rare cases of serious burns following their use. Some of the burns had serious complications requiring hospitalization," the statement adds.

People using these products should be aware for signs of skin injury, such as pain, swelling, or blistering of the skin, and should stop using the product and seek medical care if injury occurs. Healthcare professionals should counsel patients about how to use the products appropriately and inform them about the risk for serious burns, the FDA recommends.

Topical joint and muscle pain relievers may contain single agents or combinations of products, including menthol, methyl salicylate, or capsaicin, and may be formulated as creams, lotions, ointments, and patches.

"According to the available data, a majority of the more severe burns occurred with the use of a menthol or menthol/methyl salicylate combination product," the FDA notes. "Most of these cases involved products that contain higher concentrations of menthol and methyl salicylate (greater than 3% menthol or 10% methyl salicylate). Few of the cases involved capsaicin."

Healthcare providers and consumers should report any adverse events to MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm, or by mail to 5600 Fishers Lane, Rockville, Maryland 20852-9787.

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