FDA: OTC topical pain relievers cause rare cases of serious burns

The FDA has issued a warning that some over-the-counter topical products used to temporarily relieve muscle and joint pain reportedly have caused rare cases of first- to third-degree chemical burns.

The products contain menthol, methyl salicylate or capsaicin, individually or in combination, and are sold as creams, lotions, ointments and patches, the FDA said in a news release. Brand names included Bengay, Capzasin, Flexall, Icy Hot and Mentholatum.

Forty-three burn incidents associated with the products were identified in a search of the FDA’s Adverse Event Reporting System database (1969 through April 11, 2011), the National Electronic Injury Surveillance System – Cooperative Adverse Drug Event Surveillance database (2004 to 2010) and medical literature, the release said. Health care professionals confirmed the burns, although burn severity often was not specified.

Burning occurred after one application in many cases, with severe burning or blistering occurring within 24 hours. Products containing menthol as the single active ingredient or menthol (>3%) and methyl salicylate (>10%) were related to a majority of the second- and third-degree burns.

The 43 cases are a very small number when compared to the number of patients who purchase the products, FDA chemist Reynold Tan, PhD, said in the release.

The FDA is advising physicians to counsel patients about the risks for serious burns when recommending OTC topical pain relievers.

“There is no way to predict who will have this kind of reaction to a topical pain reliever for muscles and joints,” Jane Filie, MD, a medical officer in the FDA’s division of nonprescription regulation development, said in the release.