THE Therapeutic Goods Administration (TGA) has warned of the risk of overdose when using prilocaine/lidocaine cream (EMLA and various generic brands) in young babies, after investigating two recent adverse event cases.

Serious side effects associated with overdose include methaemoglobinaemia – a condition that reduces the ability of red blood cells to carry oxygen around the body.

Symptoms may include headache, dizziness, shortness of breath, nausea, poor muscle coordination and bluish appearance of the skin, and in severe cases seizures, irregular heart rhythm or even death.

The regulator has worked with the pharmaceutical companies that supply the products to ensure they include appropriate information about the risk of overdose.

Health professionals are urged to provide clear instructions about using any topical anaesthetic, noting that overdose risk is particularly high for infants.

“In the case of use on infants and young children, they should emphasise to parents and carers that using only the recommended amount for the prescribed length of time is essential to prevent potential overdose,” the TGA said.

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