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FDA Drug Safety Communication
[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
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 Fort Ord prescribed burn season begins July 1, 2012; However, they will not consider mobilizing for a prescribed burn until they have all the proper conditions. One of the key conditions is the weather. We typically see these very specific weather conditions in the Fall (September/October).
AVISO DE QUEMAS PROGRAMADAS. Después del 1 de julio del 2012, el Ejército pretende llevar a cabo una o más quemas programadas en el antigüo Fort Ord.
Register with the Direct Notification Program to be notified when a prescribed burn is imminent, when a prescribed burn is started and when it is complete. Direct notification will be provided by telephone, text, and/or e-mail for anyone who wants to receive such notification. Check www.FortOrdCleanup.com or call 1-800-852-9699 or 242-7383 for periodic updates.
If you registered for the direct notification program in prior years, you must re-register for the program in 2012. Community members can register for this program or update existing contact information by either calling the toll free number or by completing the Direct Notification Program registration form available at www.FortOrdCleanup.com for download. The web site also offers additional details on the program. The Army will use your contact information only to provide prescribed burn update information.
Registration forms can be returned to:
Base Realignment and Closure Field Office
Fort Ord Prescribed Burn Direct Notification Program
P.O. Box 5008
Monterey, CA 93944-5008
FAX: (831) 393-9188
When a baby is teething, many a mom or dad reaches for a pain remedy containing benzocaine to help soothe sore gums. Benzocaine is a local anesthetic and can be found in such over-the-counter (OTC) products as Anbesol, Hurricaine, Orajel, Baby Orajel, and Orabase.
But the use of benzocaine gels and liquids for mouth and gum pain can lead to a rare but serious—and sometimes fatal—condition called methemoglobinemia, a disorder in which the amount of oxygen carried through the blood stream is greatly reduced. In the most severe cases, says FDA pharmacist Mary Ghods, R.Ph., methemoglobinemia can result in death.
And children under 2 years old appear to be at particular risk.
Since the Food and Drug Administration (FDA) first warned about potential dangers in 2006, the agency has received 29 reports of benzocaine gel-related cases of methemoglobinemia. Nineteen of those cases occurred in children, and 15 of the 19 cases occurred in children under 2 years of age, says FDA pharmacist Kellie Taylor, Pharm.D., MPH.
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