Pain Tx in the News
FDA alert: OTC topical pain relievers linked to serious burns
September 19, 2012
First- to third-degree chemical burns have been reported following the use of topical OTC pain relievers.
The Food and Drug Administration (FDA) is warning the public that a small number of individuals has experienced first- to third-degree chemical burns following the use of certain over-the-counter (OTC) topical muscle and joint pain relievers.
Bengay, Capzasin, Flexall, Icy Hot, and Mentholatum are among the products involved. These pain relievers contain such ingredients as menthol, methyl salicylate, and capsaicin and are available in creams, lotions, ointments, and patches.
Burns after a single use
The FDA reports that many of the adverse events occurred after only one application of the product, resulting in severe burning or blistering within 24 hours. Some individuals had burns that required hospitalization.
Most of the second- and third-degree burns occurred with products containing menthol as the single active ingredient and those with both menthol and methyl salicylate. Few cases of burns have been reported with products containing capsaicin.
Forty-three cases identified
The FDA identified 43 cases of topical pain reliever burns after searching the FDA’s Adverse Event Reporting System database (1969–April 21, 2011), the National Electronic Injury Surveillance System–Cooperative Adverse Drug Event Surveillance database (2004–2010), and the medical literature.
All burns cases were confirmed by a health care professional.
What to tell your patients
The FDA encourages health care providers to tell patients to:
Avoid bandaging the area tightly and applying heating pads or hot water bottles when using these products.
Avoid applying these products to wounds or damaged, broken, or irritated skin. Also, keep these products away from the eyes and mucous membranes.
Contact a health care professional with questions or concerns about these products.
Stop using the product and seek medical attention immediately if there are signs of skin injury (eg, pain, swelling, blistering).
Report adverse events to the FDA MedWatch program at
. (Physicians should do the same.)
For more information
Read the FDA’s safety communication on OTC topical pain relievers at
1. Heng MC. Local necrosis and interstitial nephritis due to topical methyl salicylate and menthol.
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