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Risk of methaemoglobinaemia with OTC oral benzocaine

Risk of methaemoglobinaemia with OTC oral benzocaine Reactions 1704, p3 - 2 Jun 2018 Risk of methaemoglobinaemia with OTC oral benzocaine The US FDA has published a Drug Safety Communication warning that the use of over-the- counter (OTC) oral medications containing benzocaine may be associated with methaemoglobinaemia. Benzocaine is a local anaesthetic which may be used for the temporary relief of pain, such as that associated with soreness, injury or minor irritation of the mouth and throat. Formulations include gels, lozenges, ointments, solutions and sprays. The FDA warns than benzocaine products should not be used in patients <2 years of age. Manufacturers are urged to stop marketing the products for the treatment of teething in young children; lack of compliance may result in removal of the products from the market. Labelling changes for use in older patients include adding a warning about methaemoglobinaemia, and adding contraindications and revising the directions for use in teething and in patients <2 years of age. A standardised methaemoglobinaemia warning will be included in the prescribing information for all prescription local anaesthetics. Consumers using benzocaine products are advised to seek medical attention if signs of symptoms occur. These include the following: shortness of breath; headache; fatigue; confusion; or pale, grey or http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Reactions Weekly Springer Journals

Risk of methaemoglobinaemia with OTC oral benzocaine

Reactions Weekly , Volume 1704 (1) – Jun 2, 2018

Risk of methaemoglobinaemia with OTC oral benzocaine

Abstract

Reactions 1704, p3 - 2 Jun 2018 Risk of methaemoglobinaemia with OTC oral benzocaine The US FDA has published a Drug Safety Communication warning that the use of over-the- counter (OTC) oral medications containing benzocaine may be associated with methaemoglobinaemia. Benzocaine is a local anaesthetic which may be used for the temporary relief of pain, such as that associated with soreness, injury or minor irritation of the mouth and throat. Formulations include gels, lozenges, ointments,...
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Publisher
Springer Journals
Copyright
Copyright © 2018 by Springer International Publishing AG, part of Springer Nature
Subject
Medicine & Public Health; Drug Safety and Pharmacovigilance; Pharmacology/Toxicology
ISSN
0114-9954
eISSN
1179-2051
DOI
10.1007/s40278-018-46646-8
Publisher site
See Article on Publisher Site

Abstract

Reactions 1704, p3 - 2 Jun 2018 Risk of methaemoglobinaemia with OTC oral benzocaine The US FDA has published a Drug Safety Communication warning that the use of over-the- counter (OTC) oral medications containing benzocaine may be associated with methaemoglobinaemia. Benzocaine is a local anaesthetic which may be used for the temporary relief of pain, such as that associated with soreness, injury or minor irritation of the mouth and throat. Formulations include gels, lozenges, ointments, solutions and sprays. The FDA warns than benzocaine products should not be used in patients <2 years of age. Manufacturers are urged to stop marketing the products for the treatment of teething in young children; lack of compliance may result in removal of the products from the market. Labelling changes for use in older patients include adding a warning about methaemoglobinaemia, and adding contraindications and revising the directions for use in teething and in patients <2 years of age. A standardised methaemoglobinaemia warning will be included in the prescribing information for all prescription local anaesthetics. Consumers using benzocaine products are advised to seek medical attention if signs of symptoms occur. These include the following: shortness of breath; headache; fatigue; confusion; or pale, grey or

Journal

Reactions WeeklySpringer Journals

Published: Jun 2, 2018

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