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Cough and cold medicines not to be used by children under 6

The Irish Medicines Board made the announcement today, saying that there are few benefits in taking them but some risks.

CHILDREN UNDER THE age of six should no longer be given over-the-counter cough and cold medicines.

The Irish Medicines Board (IMB) made the recommendation yesterday following a review by the organisation of the safety and effectiveness of these medicines.

What medicines are affected?

These medicines include certain antihistamines, expectorants, decongestants, and antitussives (to treat coughs). Those not suitable for children under the age of six are:

  • Actifed Syrup
  • Benylin Four flu oral solution
  • Benylin Four flu tablets
  • Benylin Childrens Chesty Cough syrup
  • Benylin Childrens Cough and Colds syrup
  • Benylin Childrens Dry Coughs syrup
  • Benylin Cough Medicine syrup
  • Benylin Dry Coughs syrup
  • Benylin Dual Action Chesty Cough syrup
  • Benylin Dual Action Dry Syrup
  • Benylin NonDrowsy for Chesty coughs syrup
  • Benylin NonDrowsy for Dry coughs syrup
  • Casacol Expectorant syrup
  • Day Nurse capsules
  • Ilvico tablets
  • Lemsip Chesty Cough Oral Suspension
  • Lemsip Cough and cold capsules with caffeine
  • Lemsip decongestant and flu capsules with caffeine
  • Nirolex Chesty cough and decongestant oral solution
  • Nirolex Day Cold and Flu capsules
  • Nirolex Dry coughs with decongestant oral solution
  • Non‐drowsy Sudafed decongestant syrup
  • Otrivine Child Nasal drops
  • Pholcodex oral solution
  • Robitussin Chesty Cough oral solution
  • Robitussin Dry Cough oral solution
  • Robitussin Plus oral solution
  • Non‐drowsy Sinutab tablets
  • Sudafed Nasal spray solution
  • Tixylix Chesty Cough
  • Venos Expectorant oral solution
  • Venos honey and lemon oral solution

Why are children under six not allowed to take them?

The IMB says that while people who have used these products in the past should not be concerned, the review found “no robust evidence” that these medicines work effectively in children under six.

There have been some reports of side effects such as allergic reactions and drowsiness associated with their use and the IMB says that “given there are few benefits for children” under six years in taking the medicines but there are some risks, it is recommending that they should not be used.

Children between the ages of 6 to 12 can continue to use these cough and cold medicines 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”.

What if your child is sick?

Dr Joan Gilvarry, Director of Human Medicines, IMB, said that coughs and colds occur frequently in younger children but they generally resolve within a number of days.

Instead of giving children under six the types of medicines outlined above, she recommended:

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.

What do pharmacists think?

Darragh O’Loughlin, President of the Irish Pharmacy Union, told TheJournal.ie that he welcomed the move.

“It’s a very cautious move but appropriate when dealing with the health of young children,” he said. “It follows a similar move from the FDA in USA who have also recently recommended that cough and cold medicines not be used in children under six.”

I think the key message for parents who have used these medicines previously is to reassure them they haven’t done any harm to their child. This is a precautionary measure – not because children were harmed but because there is the theoretical risk of adverse reaction.

He said the main adverse effect that such medicines have on children is drowsiness, although some can cause hyper excitation which includes a rapid heart beat and a very excitable child.

O’Loughlin said that pharmacists would give the correct information regarding these medicines to parents and that new batches of the products would be printed with labels saying they are not for use by children under six.

Are parents too cautious?

“I’d say that parents of very small children are very cautious but almost in the opposite way to what you think,” said O’Loughlin. “They only give medicine when absolutely necessary, they would tend to recognise that cold and flu are self-limiting.”

He added that these medicines didn’t speed up the rate at which children recovered, they just alleviated the symptoms.

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