Don’t get burned by OTC topical analgesics

Pharmacists need to counsel patients about the potential for serious burns with OTC topical pain relievers

Some consumers have reported receiving serious skin injuries while using certain OTC topical pain relievers to relieve mild muscle and joint pain, FDA has warned. When these products are applied to the skin, they should produce a local sensation of warmth or coolness; they should not cause pain or skin damage. The reported cases of skin injuries ranged from first- to third-degree burns, often following one application of the product.

Menthol, methyl salicylate, and capsaicin are the main active ingredients in many OTC topical muscle and joint pain relievers and are available as either single- or combination-ingredient products. These products are sold under different brand names, such as Bengay, Capzasin, Flexall, Icy Hot, and Mentholatum, and are available as creams, lotions, ointments, and patches.

Review of data

A search of FDA’s Adverse Event Reporting System database, the National Electronic Injury Surveillance System—Cooperative Adverse Drug Event Surveillance database, and the medical literature identified 43 cases of burns on the application site associated with the use of OTC topical muscle and joint pain relievers containing the active ingredients menthol, methyl salicylate, or capsaicin. The products associated with these cases included patches, balms, and creams. All cases in this series included burns that were confirmed by a health professional. Reports of burns ranged from first degree to third degree, but many cases did not specify the degree of the burn.

Many cases occurred following one application of an OTC topical muscle and joint pain reliever, with severe burning or blistering often occurring within 24 hours of the first application of the product. A majority of the second- and third-degree burns involved the use of products containing menthol as the single active ingredient or products containing both menthol and methyl salicylate with a concentration of greater than 3% and 10%, respectively. Few reported cases involved a capsaicin-containing product.

Counseling tips

Current FDA regulations do not require the Drug Facts box on OTC topical muscle and joint pain relievers to warn that use of the products could result in serious burns. There is no way to predict who will have this kind of reaction to a topical pain reliever, so pharmacists, as the members of the health care team most often available at the point of purchase, have an opportunity to help educate and raise awareness among patients about the potential for adverse events.

Pharmacists counseling patients and caregivers seeking OTC topical muscle and joint pain reliever products containing menthol, methyl salicylate, or capsaicin should offer the following counseling pearls:

  • If you experience pain, swelling, or blistering of the skin, stop using the product and seek medical attention immediately.
  • Do not bandage the area tightly after applying the product.
  • Do not apply local heat such as heating pads, lamps, or hot water in bags or bottles, as doing so can increase the risk of serious burns.
  • Do not apply to wounds or damaged, broken, or irritated skin.
  • Do not allow contact with eyes and mucous membranes, such as the skin inside your nose, mouth, or genitals.
  • Report unexpected adverse effects to the FDA MedWatch program at www.fda.gov/MedWatch/report.htm.

For more information, read FDA’s September 2012 Drug Safety Communication.