其 他 安 全 警 示
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| Australia: Risk of overdose in infants when using prilocaine/lidocaine cream (EMLA and generics) (English only) |
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Summary
The Therapeutic Goods Administration (TGA) has received 2 serious adverse event cases in neonates in which EMLA (topical prilocaine/lidocaine(lignocaine) 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, you should provide clear instructions about using any topical anaesthetic, emphasising the recommended amount and length of application.
Use of EMLA
The registered indications for EMLA are topical anaesthesia of:
- the skin prior to insertion of IV catheters, blood sampling, vaccination; superficial surgical procedures, including split skin grafting
- leg ulcers to facilitate mechanical cleansing and debridement
- the genital skin prior to superficial surgical procedures or infiltration anaesthesia
- the skin prior to minor superficial cosmetic procedures.
Adverse events reported to us
Our publicly searchable Database of Adverse Event Notifications contains:
- 1 report of ‘seizure’ (1 of the reports mentioned below)
- 3 reports of ‘methaemoglobinaemia’, 2 of which are in patients under 1 year of age (which includes 1 of the cases mentioned below).
In October 2024, the TGA received 2 serious reports (1 case of seizure and 1 case of methaemoglobinaemia) following the topical administration of EMLA in preparation for circumcision. The TGA conducted a signal investigation to review these cases and found both were likely to have involved an overdose of the topical anaesthetic.
The following reports triggered this signal investigation:
- A 3-week-old male neonate hospitalised with a seizure following the reported administration of 3-4 g of EMLA on the penile shaft for circumcision. The child was not exposed to any other medicines and was treated supportively.
- A 3-week-old male neonate hospitalised with cyanosis and in respiratory distress following a circumcision and 3 g of EMLA applied topically to the shaft of his penis. The child was diagnosed with methaemoglobinaemia.
Response to adverse event notifications
The risk of methaemoglobinaemia and seizure in overdose were previously described in the EMLA Product Information (PI) and Consumer Medicine Information (CMI). In response to these adverse event notifications, the product label, package insert and CMI have been updated to emphasise the need to not exceed the maximum recommended dose or application time, as well as highlight that children, particularly those under 3 months of age, are at an increased risk of serious adverse effects in overdose. The package insert also now specifies a maximum length of application (maximum of 1 hour) for neonates and infants (0-3 months) when used for circumcision. We are currently working with sponsors (pharmaceutical companies) of the generic products to update their PIs, CMIs, product labels and package inserts.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/news/safety-updates/risk-overdose-infants-when-using-prilocainelidocaine-cream-emla-and-generics
In Hong Kong, there are 12 registered pharmaceutical products which are prilocaine/lignocaine cream, including EMLA Cream 5% (HK-27892) registered by Aspen Pharmacare Asia Limited O/B Aspen Pharmacare Asia Limited. All products are pharmacy-only medicines. So far, the Department of Health (DH) has not received any case of adverse drug reaction with regard to prilocaine/lignocaine cream. Among the registered products in Hong Kong, nine of the registered products are indicated also for use in infants and maximum dose and application time have already been included in their package inserts, while one product is labelled to be used only as directed by physicians and another product with “Until further clinical experience is available, consult your doctor before using in infants under the age of 12 months” listed on its package insert.
The risk of methaemoglobinaemia associated with the use of prilocaine/lignocaine cream in infants, as well as the recommended maximum amount to be used with length of application, is also documented in overseas reputable drug references such as the “Martindale: The Complete Drug Reference” and “British National Formulary for Children”. The DH will remain vigilant on any safety update of the drugs issued by other overseas drug regulatory authorities.
Ends/Friday, Oct 3, 2025
Issued at HKT 18:30
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