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Six baby cough medicines pulled

A baby held by a parent
About 100 baby cough remedies are set to be relabelled

Cough remedies aimed at very young children are to be removed from shelves amid fears of accidental overdose.

The Medicine and Healthcare products Regulatory Agency has ordered six products be permanently removed from sale for children aged under two.

They are Asda Children's Chesty Cough Syrup, Calcough Chesty and Boots Chesty Cough Syrup - one year plus.

Also, Children's Chesty Cough and Boots sore throat and cough linctus one year plus and Buttercup infant cough syrup.

There's nothing wrong with these medicines, it was the way that they had been given
Sara Coakley
MHRA

The medicines are to be removed from open shelves, and will not be sold by pharmacists for children under two.

Instead, parents are being urged to stick to paracetamol and ibuprofen medicines, vapour rubs and simple cough syrup such as glycerol, honey or lemon.

Pure honey should not be given to children under one, but medicines are safe as they contain a processed version of the foodstuff.

There are 12 ingredients found in the remedies causing concern.

They are brompheniramine; chlorphenamine; diphenhydramine; dextromethorphan; pholcodine; guaifenesin; ipecacuanha; phenylephrine; pseudoephedrine; ephedrine; oxymetazoline and xylometazoline.

'Precautionary measure'

The medicines of concern all contain a combination of these ingredients.

MEDICINES NOT TO BE USED FOR UNDER-TWOS
Buttercup Infant Cough Syrup
Boots Chesty Cough Syrup one-year plus
Boots Sore Throat and Cough Linctus one-year plus
Calcough Chesty
Children's Chesty Cough
Asda Children's Chesty Cough Syrup

The MHRA says there is no evidence that such multi-ingredient medicines are of any benefit to the under-twos.

There have been concerns in the US over such medicines after parents gave children too high a dose, or more than one product containing the same ingredients.

There have also been some similar reports in the UK.

There have been five deaths in children under two since 1981 where cough and cold medicines may have been a factor, according to the MHRA.

About 90 more cough remedies which are licensed for use in over-twos are to be removed from shelves until they can be repackaged to include advice that they should not be given to children under that age.

Until that time, they will be kept behind pharmacy counters.

READ THE LIST IN FULL

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MHRA spokeswoman Sara Coakley said: "It's a precautionary measure. They are not dangerous."

She went on: "If they had been dangerous, we'd have had them off the market in seconds. Nobody should panic.

"There's nothing wrong with these medicines, it was the way that they had been given."

Overdose risk

Anyone who asks to buy these products will be questioned about the age of the child who is unwell.

ADVICE TO PARENTS
Use either paracetamol or ibuprofen to relieve a baby or toddler's pain and lower their temperature
To treat a cough, simple mixtures of glycerol, lemon and honey are best
If a child over two has a cough, over-the-counter medicines can be used
Vapour rubs and infant decongestants plus saline drops can be used to relieve a stuffy or blocked nose

The product can be sold if the child is older than two and an advice leaflet will be provided.

The spokeswoman said the medicines could be dangerous if people gave a child more than the recommended dose, or gave them more than one product at the same time.

She said the advice had been updated after they found many parents were unwittingly overdosing children.

She said youngsters under two are "particularly susceptible because of their small size", creating a "risk of overdose".

And she admitted there had been an increase in "adverse reactions" to the products, although she said this had been more widely observed in the United States where improved packaging had since been introduced.

Sheila Kelly, of the Proprietary Association of Great Britain (PAGB) said the industry was voluntarily removing the doses for children under two from the labels of many cold and cough remedies.

She added: "Products with the new labelling will be introduced as soon as possible over the next six months."

And David Pruce, of the Royal Pharmaceutical Society of Great Britain, added: "It is good practice to restrict the use of over-the-counter products for the treatment of cough and cold symptoms in children under two."



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