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FDA Issues Public Health Advisory About Benzocaine Sprays
FDA Safety Information and Adverse Event Reporting Program
BETHESDA, MD -- February 13, 2006 -- FDA issued a Public Health Advisory to notify healthcare professionals and patients about adverse events, including methemoglobinemia, associated with the use of benzocaine sprays used in the mouth and throat.
Benzocaine sprays are used in medical practice for locally numbing mucous membranes of the mouth and throat for minor surgical procedures or when a tube must be inserted into the stomach or airways.
On February 8, 2006, the Veterans Health Administration (VA) announced the decision to stop using benzocaine sprays for these purposes.
The FDA is aware of the reported adverse events and is reviewing all available safety data, but at this time is not planning action to remove the drugs from the market.
The FDA is highlighting safety information previously addressed by the Agency (see link below), has provided other information for the consideration of clinicians in the PHA and will make further announcements or take action as warranted by the ongoing review.
Read the complete MedWatch 2006 Safety summary, including links to the Public Health Advisory and supporting FDA documents, at:
http://www.fda.gov/medwatch/safety/2006/safety06.htm#benzocaine
SOURCE: Food and Drug Administration
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