[Posted 04/07/2011] ISSUE: FDA notified healthcare professionals and patients that FDA continues to receive reports of methemoglobinemia, a serious and potentially fatal adverse effect, associated with benzocaine products both as a spray, used during medical procedures to numb the mucous membranes of the mouth and throat, and benzocaine gels and liquids sold over-the-counter and used to relieve pain from a variety of conditions, such as teething, canker sores, and irritation of the mouth and gums.
BACKGROUND: Methemoglobinemia is a rare, but serious condition in which the amount of oxygen carried through the blood stream is greatly reduced. In the most severe cases, methemoglobinemia can result in death. Patients who develop methemoglobinemia may experience signs and symptoms such as pale, gray or blue colored skin, lips, and nail beds; headache; lightheadedness; shortness of breath; fatigue; and rapid heart rate. Methemoglobinemia has been reported with all strengths of benzocaine gels and liquids, and cases occurred mainly in children aged two years or younger who were treated with benzocaine gel for teething. The signs and symptoms usually appear within minutes to hours of applying benzocaine and may occur with the first application of benzocaine or after additional use. The development of methemoglobinemia after treatment with benzocaine sprays may not be related to the amount applied. In many cases, methemoglobinemia was reported following the administration of a single benzocaine spray.
RECOMMENDATIONS:
Benzocaine products should not be used on children less than two years of age, except under the advice and supervision of a healthcare professional.
Adult consumers who use benzocaine gels or liquids to relieve pain in the mouth should follow the recommendations in the product label. Consumers should store benzocaine products out of reach of children. FDA encourages consumers to talk to their healthcare professional about using benzocaine.
Read the two Drug Safety Communications below for other specific recommendations for Healthcare Professionals, for Consumers and Caregivers and the Data Summary which supports these recommendations.
FDA is continuing to evaluate the safety of benzocaine products and the Agency will update the public when it has additional information. FDA will take appropriate regulatory actions as warranted.
For more information visit the FDA website at: [Web] and [Web].
This medicine is applied to the affected area of the mouth or gums. Wash your hands before and after using this medicine. Follow the directions on the label or those given to you by your doctor or health care professional. Do not use this medicine more often than directed.
Talk to your pediatrician regarding the use of this medicine in children. While this medicine may be used in children as young as 4 months for selected conditions, precautions do apply.
What should I watch for while using this medicine?
This medicine is not for long-term use. Do not use for longer than directed on the label or your doctor or health care professional. Do not use on large areas of broken or damaged skin. Contact your doctor or health care professional if your condition does not start to get better within a few days or if you notice redness, itching or swelling.
The affected area of your mouth will be numb. Try to avoid injury to that area. To avoid biting the tongue or cheek, or difficulty swallowing, do not chew gum or food until the numbness wears off.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):
redness, swelling, or pain
Where should I keep my medicine?
Keep out of the reach of children.
Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Do not freeze. Throw away any unused medicine after the expiration date.
Remember, keep this and all other medicines out of the reach of children,
never share your medicines with others, and use this medication only for the indication prescribed.
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