Notice type: 3rd Party Publications
Problem Or Issue:
Recent advice from the Food and Drug Administration (FDA) in the US and the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK highlighted concerns regarding the safety of cough and cold medicines for use in children, particularly those under two years of age. These concerns related to reports of serious adverse reactions including isolated cases of fatalities which mainly occurred in the US. Available post-mortem data identified high levels of the cough/cold medicine used, suggesting possible errors related to dosing and/or concomitant use of a range of combination products.
The IMB has never recommended use of these products for the treatment of cough/cold symptoms in children under two years of age, except on the specific advice of a doctor or pharmacist and none of the products withdrawn from sale in the UK were available in Ireland.
The use of cough and cold medicines in older children is currently under review at a European level and the IMB is participating in this review. Pending its completion, the IMB recommends that for children aged 2-6 years, parents/care-givers should be advised as follows:
The advice of healthcare professional should be sought before administering cough/cold medicines to children aged 2-6 years
The recommended dosing schedule should be followed and the maximum daily dose should not be exceeded.
Other cough/cold medicines should not be taken at the same time.
If symptoms persist beyond 2-3 days of treatment, medical advice should be sought.
The IMB recommends that children who have symptoms of a cold and an associated temperature should be treated with paracetamol or ibuprofen. These products can improve the child’s symptoms and can be used in conjunction with cough syrups such as glycerol, honey or lemon. Parents and care-givers should be reminded to carefully read the package leaflet and strictly administer the correct dosage as specified. Special attention should be given to reading the label and ensuring that the maximum dosage level and frequency are not exceeded.
Any suspected adverse reactions brought to your attention in association with use of these products should be notified to the IMB in the usual way.