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

Welcome to the FDA Drug Safety Podcast from the Division of Drug Information. Today’s topic: Rare cases of serious burns with the use of over-the-counter topical muscle and joint pain relievers
On September 13, 2012, the FDA issued a Drug Safety Communication alerting the public that certain over-the-counter, or 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.
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. 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.
At this time the FDA recommends that Health Care Professionals be aware of the following:

Rare cases of serious burns have been reported to occur on the skin where 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. The 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 at www.fda.gov/medwatch².

Narrator: Thank you for listening. The FDA is committed to keeping healthcare professionals informed of the latest safety information. A link to this communication, including the complete Data Summary, can be found at www.fda.gov/DrugSafetyCommunications³. If you have drug questions, you can reach us at druginfo@fda.hhs.gov.