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 blue- coloured skin, lips and nail beds. Symptoms may appear within minutes of use, or within 1 2 hours. Healthcare professionals should warn patients about the potential risk, particularly in those with breathing problems or heart disease, or the elderly. Investigation of safety issues will continue, and the public will be updated if additional information becomes available. Patients and healthcare professionals are urged to report any further adverse events involving benzocaine to the FDA MedWatch program. * Brand names include Anbesol, Hurricaine, Orabase, Oragel and Baby Oragel, and Topex. US Food & Drug Administration. Oral Over-the-Counter Benzocaine Products: Drug Safety Communication - Risk of Serious and Potentially Fatal Blood Disorder Internet Document : 23 May 2018. Available from: URL: https:// www.fda.gov/Safety/MedWatch/SafetyInformation/ SafetyAlertsforHumanMedicalProducts/ucm608612.htm 803323901 0114-9954/18/1704-0001/$14.95 Adis © 2018 Springer International Publishing AG. All rights reserved Reactions 2 Jun 2018 No. 1704
Reactions Weekly – Springer Journals
Published: Jun 2, 2018
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