Today the Irish Medicines Board announced that they are recommending a number of new measures in relation to the use of over counter (OTC) cough and cold medicines for children. Following a review by the IMB of safety and effectiveness of these medicines, they are advising that children under the age of six should no longer be given such medicines.
 
The IMB states that those who have used these medicines should not be alarmed. The review found that these medicines are not effective on children under six, however these medicines can cause allergic reactions and drowsiness. Given that there are few benefits but some risks in taking these OTC cough and cold medicines, the IMB is recommending that they should no longer be in use.
 
For 6-12 year olds, the IMB is advising that these medicines can continue to be used but care should be taken to ensure that the maximum daily dose is not exceeded and that no other cough or cold medicine is taken at the same time. 
 
According to Dr Joan Gilvarry, Director of Human Medicines, IMB, coughs and colds occur frequently in children, especially in younger children, but they generally resolve within a number of days. 
 
“Using simple measures such as plenty of fluids and rest to ease the symptoms are likely to be effective, but paracetamol and ibuprofen can be used to assist in reducing the temperature if needed. If your child is not getting better or you have any concerns about their condition you should consult with your doctor or pharmacist. In children over the age of six years, these cough and cold medicines can continue to be used where necessary. This is because the risk of side effects is reduced in older children as they weigh more, get fewer coughs and colds and can say if the medicine is working or not.”
 
Key Recommendations:
  • Cough and cold medicines containing certain active ingredients should not be used in children under six years as the benefit-risk balance in this age group has not been shown to be favourable.
  • For children aged 6-12 years, OTC medicines to treat cough and colds can continue to be considered where necessary. Care should be taken to ensure adherence to the maximum daily dose and to ensure that the product is not taken with another cough and cold medicines.
  • In the context of paediatric use, OTC cough and cold medicines containing the active ingredients listed below will continue to be available for use in children aged between 6 and 12 years, but in pharmacies only, where advice can be given regarding their use.
The product information for these medicines, including the package leaflet, is currently in the process of being updated to reflect this new advice. The introduction of OTC cough and cold medicines with the updated labelling has already commenced for the 2011 cough and cold season, and the products with updated labelling will continue to be introduced to pharmacies over the coming months.
 
A letter has also been sent to all General Practitioners and Pharmacists to advise them of these changes. This letter is available on the IMB website www.imb.ie.

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