ISSUE 6 DECEMBER
Reproduced with permission from Therapeutic Goods Administration (TGA) Medicines Safety Update 2 October 2025.
Summary
The TGA has received 2 serious adverse event reports in neonates in which EMLA (topical prilocaine+lidocaine cream) was applied for a circumcision procedure. Both cases were likely to have involved overdose.
Prilocaine+lidocaine cream (EMLA and various generics) is used for topical anaesthesia of the skin before various minor procedures.
Overdose of EMLA can cause serious adverse effects including methaemoglobinaemia, which in severe cases can lead to seizures or even death.
Methaemoglobinaemia is a condition in which elevated methaemoglobin in the blood disrupts the haemoglobin that transports oxygen around the body. Symptoms may include headache, dizziness, shortness of breath, nausea, poor muscle coordination and cyanosis. Complications may include seizures and heart arrhythmias.
When EMLA and other lidocaine+prilocaine topical cream preparations are provided over the counter without a prescription, consumers may not routinely receive advice on use from a health professional.
What health professionals should do
Health professionals should instruct parents and carers to use no more than the recommended amount of EMLA on the child's skin, and to leave it on the skin for only the recommended length of time.
When preparing infants for circumcision, the recommended amount is 1 g applied to the prepuce for a maximum of 1 hour.
In general, health professionals should provide clear instructions about using any topical anaesthetic, emphasising the recommended amount and length of application.
See the full article on the TGA website.
