Dr. Richard Hoffmann, Ask the Pharmacist, 09/25/12

Q: I heard the FDA was warning people about using topical pain relievers. What can you tell me about it?

A: On Sept. 13, the FDA issued a consumer safety announcement that warned about the potential risks of certain over-the-counter (OTC) topical pain relievers such as Bengay, Capzasin, Flexall, Icy Hot, Mentholatum and others.

In this announcement, the FDA alerted 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.

When applied to the skin, these 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 percent menthol and 10 percent methyl salicylate.

Few cases reported using a capsaicin-containing product. The FDA provides the following advice for people using these products:

+ 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.

+ 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.

Richard P. Hoffmann, Pharm.D., has been a pharmacist for more than 40 years. Send questions to him at 2960 E. Coventry Court, Hernando, FL 34442.