FDA warns OTC muscle pain relievers can cause chemical burns
Posted in Drug & Medical Devices on September 18, 2012
The U.S. Food and Drug Administration is alerting the public that certain muscle pain relievers designed to be rubbed into the skin – like Bengay and Icy Hot – can in rare cases cause serious chemical burns.
The over-the-counter products are applied to the skin for relief of mild muscle and joint pains. Most of these products contain menthol, methyl salicylate or capsaicin. When applied to the skin, the products create a local sensation of warmth or coolness. They shouldn’t cause pain or skin damage.
But FDA regulators say they have received reports of skin injuries ranging from first- to third-degree chemical burns caused by the products. Some of burns have required hospitalization, according to a notice posted on the FDA’s website.
Based on the FDA’s analysis of 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 with a concentration of ingredients that was greater than 3 percent menthol and 10 percent methyl salicylate.
Present FDA guidelines do not require these products to have warnings on their labels about burns to the skin.
The FDA is asking consumers to discontinue use of these pain relief products if any sign of skin injury, including pain, swelling or blistering, appears and requests that physicians instruct patients on the appropriate use of the cream, ointment, patch or gel pain relievers that contain any of the aforementioned ingredients.
When using OTC topical muscle and joint pain relievers, the FDA recommends that you not bandage the area tightly and that you not apply local heat (heating pads, lamps, hot water in bags or bottles) to the area because doing so can increase the risk of serious burns.
The FDA also says you should not apply these pain relievers to wounds or damaged, broken or irritated skin.
The drug recall attorneys of Elk & Elk have almost 50 years’ experience helping clients who have been injured by defective drugs or medical devices. Call 1-800-ELK-OHIO today or fill out our online consultation form to see how we can help you.