Other safety alerts
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| The United States: FDA Drug Safety Communication: Rare cases of serious burns with the use of over-the-counter topical muscle and joint pain relievers |
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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.
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.
FDA advised that 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 recommending OTC topical muscle and joint pain relievers to patients, healthcare professionals should counsel patients about how to use the products appropriately and inform them about the risk of serious harms.
Please refer to the following website in FDA for details:
http://www.fda.gov/Drugs/DrugSafety/ucm318858.htm
In Hong Kong, there are some topical pharmaceutical products containing menthol and/or methyl salicylate registered for relieving muscle and joint pain. Most of them are non-prescription medicines. No relevant adverse drug reaction report was received by Department of Health. Patient if feeling unwell after consumed the medicine, he/she should stop the medicine and consult doctor. Healthcare professionals are encouraged to report any adverse events caused by the drugs to the Pharmacovigilance Unit of Department of Health (tel. no.: 2319 2920, fax: 2147 0457 or email: adr@dh.gov.hk). In view of the FDA’s recommendation, a letter to inform healthcare professionals will be issued.
Ends/ Friday, September 14, 2012
Issued at HKT 17:00 |
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