The MHRA is poised to issue updated guidance on the use of codeine-containing medicines in children aged over 12 years, it advised this week, following a European review of the painkiller. 

The MHRA will issue detailed advice in due course, it said on Friday (June 14) in response to a European Medicines Agency (EMA) recommendation that codeine-containing medicines should only be used in children aged over 12 years to treat acute moderate pain if it cannot be relieved by other painkillers.

The EMA's Pharmacovigilance Risk Assessment Committee (PRAC) reviewed codeine guidance in October last year at the MHRA's request, following reports of children suffering serious adverse effects and even dying after taking the pain relief.

European regulators have recommended that codeine should only be used in children aged over 12 years to treat acute moderate pain if it cannot be relieved by other painkillers	More on painkillers Nice formalises guidance on analgesics in feverish       under-fives Pharmacists should highlight cardiovascular risks of       diclofenac Pharmacists must overcome 'fear' of ibuprofen use       in children MORE NEWS
	PRAC said last week that most of the cases occurred after children had taken codeine for sleep apnoea following the surgical removal of their tonsils or adenoids. It concluded that the painkiller was associated with a risk of hypoventilation in the over-12s.

PRAC recommended that ibuprofen or paracetamol should be the first option for treatment and codeine should not be used at all for children aged under 18 years who have had their tonsils or adenoids removed, as they were more susceptible to respiratory problems.

It also advised that codeine prescribing information should carry a warning about breathing problems and that the drug should not be used in people of any age who are known to be ultra-rapid metabolisers and could have a bad reaction to codeine, or in women who are breastfeeding.

The EMA said that the limited data on codeine's effectiveness as pain relief in children suggested its effect was "not significantly better" than painkillers such as paracetamol or ibuprofen.

MHRA deputy director of vigilance and risk management of medicines Sarah Branch said: "While codeine is not particularly widely used in children, it should be used at the lowest effective dose and only for the shortest period of time recommended by the doctor."

The BNF for Children advises codeine can be considered for moderate pain but advises caution for children with impaired respiratory function and asthma and warns of the varied rates of metabolising the drug.

PRAC's recommendations will now be considered by the European regulatory agency CMDh at its meeting later this month (June 24-26), which will prompt a legally binding decision for all EU member states to adhere to.