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FDA Issues Reminder on Risk for Methemoglobinemia with Topical Benzocaine
The FDA is reminding healthcare providers that benzocaine sprays, gels, and liquids carry an increased risk for methemoglobinemia. The product labels do not currently warn about this risk.
To date, there have been 319 reported cases of methemoglobinemia, including seven fatalities, related to benzocaine sprays used to numb the oral mucosa during medical procedures. There have also been 21 cases from over-the-counter gels and liquids used to treat oral pain. Onset generally occurs from several minutes to 2 hours after application and seems to be unrelated to the dosage.
The FDA advises clinicians to monitor for signs of methemoglobinemia — including bluish skin, lips, and nail beds; shortness of breath; reduced oxygen saturation; and tachycardia — for at least 2 hours after applying benzocaine sprays. In addition, consumers using OTC benzocaine should be made aware of these signs.
The agency also notes that benzocaine should not be used in children younger than 2 years.
LINK(S):
FDA MedWatch alert (Free)
Published in Physician's First Watch April 8, 2011
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