Benzocaine Products Carry Risk of Blood Disorder, FDA Warns

The Food and Drug Administration (FDA) says it 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.

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.

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Published In: Administrative Agency Updates, Consumer Protection Updates, Products Liability Updates

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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