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FDA Drug Safety Communication: Rare cases of serious burns with the use of over-the-counter topical muscle and joint pain relievers


Safety Announcement
Additional Information for Consumers
Additional Information for Health Care Professionals
Data Summary
References

Safety Announcement

[9-13-2012] The U.S. Food and Drug Administration (FDA) is alerting the public that certain over-the-counter (OTC) products that are applied to the skin for the relief of mild muscle and joint pain 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.

Facts about OTC topical muscle and joint pain relievers
  • Used to temporarily relieve minor muscle and joint aches and pain
  • Marketed under various brand-names, such as, 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.

Additional Information for Consumers

  • 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.
  • If you experience pain, swelling, or blistering of the skin where an OTC topical muscle and joint pain reliever was applied, stop using the product and seek medical attention immediately. These products should not cause pain or skin damage. These products produce local warmth or coolness.
  • When applying OTC topical muscle and joint pain relievers to the skin, do not bandage the area tightly and do not apply local heat (heating pads, lamps, hot water in bags or bottles) because doing so can increase the risk of serious burns.
  • Do not apply OTC topical muscle and joint pain relievers to wounds or damaged, broken, or irritated skin. Also do not allow contact with eyes and mucous membranes (such as the skin inside your nose, mouth, or genitals).
  • Talk to a health care professional if you have any questions or concerns about using OTC topical muscle and joint pain relievers.
  • Report side effects from the use of OTC topical muscle and joint pain relievers to the FDA MedWatch program, using the information in the "Contact FDA" box at the bottom of the page.

Additional Information for Health Care Professionals

  • 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 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.
  • When recommending OTC topical muscle and joint pain relievers to patients, counsel them about how to use the products appropriately and inform them about the risk of serious burns. 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 topical pain relievers to carry a warning that use of the products could result in serious burns.
  • If a patient experiences pain, swelling, or blistering of the skin where an OTC topical muscle and joint pain reliever was applied, advise the patient to discontinue using the product.
  • Report adverse events involving OTC topical muscle and joint pain relievers to the FDA MedWatch program using the information in the "Contact FDA" box at the bottom of this page.

Data Summary

A search of FDA’s 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.

References

  1. Heng MC. Local necrosis and interstitial nephritis due to topical methyl salicylate and menthol. Cutis 1987;39:442-4.

 

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