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FDA says tooth pain gels, sprays may carry health risk

April 13, 2011

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Washington – Pain relief sprays, gels and liquids containing benzocaine may pose serious health risks, the Food and Drug Administration warned April 7.

These medications are sold over the counter to alleviate pain from a variety of sources, including teething and canker sores. They can lead to a rare but potentially fatal condition known as methemoglobinemia, in which the amount of oxygen carried through the bloodstream is significantly reduced.

Signs of the condition typically appear within minutes or hours of applying the medication, and include pale, gray or blue-colored skin, lips and nail beds; headache; lightheadedness; shortness of breath; fatigue; and rapid heart rate. If symptoms are identified after benzocaine use, seek medical attention immediately.

FDA recommends not using benzocaine products on children younger than 2, unless under the advice and supervision of a health care professional. Adult users should follow recommendations listed on the product label.

FDA encourages consumers to report adverse effects associated with benzocaine or other products to the MedWatch Safety Information and Adverse Event Reporting Program. Reports can be submitted online or forms can be requested by calling (800) 332-1088.

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