Reported adverse event cases of methemoglobinemia associated with benzocaine products.
BACKGROUND
Methemoglobinemia (MHb) is characterized by abnormal levels of oxidized hemoglobin that cannot bind and transport oxygen. When induced by benzocaine anesthetic spray and other chemicals, it can result in cyanosis and life-threatening complications.


METHODS
From 818 439 adverse event reports received by the US Food and Drug Administration from November 1997 through March 2002, we extracted every report for use of a benzocaine product. We classified each case by product type (eg, spray, gel, or solution), by whether MHb was involved, and by the dose given.


RESULTS
Among 198 reported adverse events of all types associated with benzocaine, 132 cases (66.7%) involved definite or probable MHb. The MHb cases included 107 serious adverse events (81.1%) and 2 deaths (1.5%). In 123 cases (93.2%), the product was a spray; in 2 cases (1.5%), a benzocaine-containing lozenge; and 1 case, a gel. In the 69 cases that specified a dose, 37 (53.6%) indicated that a single spray was applied (approximately the recommended amount).


CONCLUSIONS
Health professionals involved in endoscopy, intubation, bronchoscopy, or similar invasive procedures using benzocaine-containing sprays should know that (1) administration may cause MHb with potentially serious consequences, (2) identifying the reaction to benzocaine usually requires cooximetry (although it can be implied by symptoms), and (3) treatment involves immediate intravenous administration of 1 to 2 mg/kg of methylene blue.
Moore
Thomas J
TJ
Institute for Safe Medication Practices, Huntingdon Valley, PA, USA. tmoore@ismp.org
Walsh
Christopher S
CS
Cohen
Michael R
MR
D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D017677:Age Distribution; D000368:Aged; D000779:Anesthetics, Local / Q000008:administration & dosage / Q000009:adverse effects*; D001566:Benzocaine / Q000008:administration & dosage / Q000009:adverse effects*; D005260:Female; D006801:Humans; D008297:Male; D008708:Methemoglobinemia / Q000139:chemically induced* / Q000453:epidemiology; D008875:Middle Aged; D010092:Oximetry; D014481:United States; D014486:United States Food and Drug Administration
D000779:Anesthetics, Local; D001566:Benzocaine