Cough medicine banned for children under two as 100 remedies are taken off the shelves | the Daily Mail

Cough medicine banned for children under two as 100 remedies are taken off the shelves
BY JENNY HOPE - More by this author »

Last updated at 12:41pm on 27th March 2008

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A small child receives cough medicine - but the treatments contain ingredients that could be fatal in high doses (picture posed by model)
Cough and cold remedies for children under two are to be pulled from the shelves immediately amid safety fears.

At least 100 products will be put under the counter as parents are warned about the danger of giving toddlers potentially fatal overdoses.


The dramatic move means popular medicines will effectively be banned for any youngster under the age of two and parents of all children up to six will have to ask for them.


It could signal a return to old-fashioned remedies such as honey and lemon drinks.

Best-selling brands affected include Tixylix, Robitussin, Benylin and Calpol.


The alert centres on 12 ingredients in the medicines, many of which have been used by drug firms for years.

At least five deaths of British children under two have been linked to cough and cold remedies and more than 100 serious cases of suspected adverse reactions have been reported.




The list of banned medicines


A similar warning was issued in the U.S. in January.



A small child receives cough medicine - but the treatments contain ingredients that could be fatal in high doses (picture posed by model)

Today, six products directly targeted at children under two will be removed from open sale, although they may still be supplied by a pharmacist for use with older children.


They include Boots Chesty Cough Syrup 1 Year Plus and Asda Children's Chesty Cough Syrup.


Another 59 products - authorised for use in children under two but not marketed at them - will also be taken off the shelf and sold only to parents whose children are older.


A further 58 products aimed only at children aged two to six will also be taken down.

Anyone buying any of the 117 products will be instructed on the exact dose they should give.


In the long term, manufacturers will re-label and re-package them so they can go back on normal sale.


In a simultaneous move, parents will be told to use temperature-lowering drugs such as paracetamol or ibuprofen to treat babies and toddlers suffering cold symptoms.


They will also be advised to use a simple cough syrup such as glycerol, honey or lemon, with vapour rubs for a stuffy nose.

Parents of children under two who have any of the affected products at home will be advised to take them to a pharmacist or back to where they bought them.


Those with children between two and six are being urged to seek advice before using the products.


The updated advice comes from the drug safety watchdog, the Commission on Human Medicines.


None of the remedies has been shown to be dangerous when used correctly.

But there has been growing concern that parents may unwittingly give children too much, because they either miscalculate the dose or use additional doses to ensure the medicine works.


Mixing different products can also lead to an overdose if they contain the same ingredient.


Children under two are at greatest risk simply because they are smaller.


Last year the American College of Chest Physicians said cough mixtures were of little use to adults and could harm children.

Research by U.S. doctors showed that plain honey was better than many expensive medicines.


Professor Rosalind Smyth, chairman of the CHM paediatric medicines expert advisory group, said last night: "Coughs and colds are generally self-limiting conditions which will get better themselves, usually within a few days.

"The management of symptoms in the under-twos is best achieved with treatment to control fever - ibuprofen or paracetamol - together with simple cough mixtures."

Cambridgeshire GP Dr David Haslam said parents should not panic.

He said: "This is about removing potential risk.


"The problem with combination products is that children get a potentially toxic cocktail of ingredients.

"It's safer to use the tried and tested remedies of paracetamol and ibuprofen.

"We know how they work and what the side effects are."

The ingredients that will no longer be licensed for children under two are the antihistamines brompheniramine, chlorphenamine and diphenhydramine; cough suppressants dextrometorphan and pholcodine; expectorants guaifenesin and ipecacuanha and decongestants phenylephrine, pseudoephedrine, ephedrine, oxymetazoline and xylometazoline.


The Proprietary Association of Great Britain, which represents medicine makers, is launching an information campaign with leaflets in pharmacies and other shops

Don’t panic message over children’s cough mixture - Times Online

Don’t panic message over children’s cough mixture



Nigel Hawkes, Health Editor


Parents were told yesterday not to be alarmed by the decision to remove six cough and cold remedies for young children from chemists’ shelves.
The medicines, specifically marketed for use by children under 2, were not unsafe but were being removed from open sale because of fears of an accidental overdose.
Labelling on dozens of other cough and cold remedies was being changed after new advice was issued by drug safety watchdogs.
But the Proprietary Association of Great Britain, which represents the makers of the medicines, emphasised that they were not being banned for use by older children and were still safe when used as directed.
Sheila Kelly, a spokeswoman for the association, said: “Companies are taking this action voluntarily because the wellbeing of babies and young children is paramount. Parents should not be concerned that they have harmed their children if they have given them cold remedies in the past. Many of the products have been on the market for over 40 years – they are safe when used as recommended.”
Labelling on products containing antihistamines, decongestants, cough suppressants and expectorants will be changed over the next six months so that they are recommended only for children aged over two.
Parents are now being advised to give children under 24 months para-cetamol or ibuprofen to lower their temperature if they have a cold.
Simple cough syrups containing glycerol, and honey and lemon could also be given, as well as vapour rubs and inhalant decongestants.
The Medicine and Healthcare products Regulatory Agency (MHRA) said that anyone who asked to buy the affected products would be questioned about the age of the patient. If the child was older than 2, the product could be sold and an advice leaflet would be provided.
A spokeswoman for the MHRA said that letters were sent to healthcare professionals yesterday explaining the move. “It’s a precautionary measure,” she said. “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.”
She said that the remedies could be dangerous if people gave their child more than the recommended dose or more than one product at a time. She admitted there had been an increase in “adverse reactions” to the products but said that that had been more widely seen in the US.
Counter measures
The six products, previously marketed for use by children under two, that have been removed:
— Asda Children’s Chesty Cough Syrup
— Boots Chesty Cough Syrup One Year Plus
— Boots Sore Throat and Cough Linctus One Year Plus
— Buttercup Infant Cough Syrup
— CalCough Chesty
— Bell’s Children’s Chesty Cough