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December 13, 2013 – Novartis Consumer Health UK LTD (NCH) announced today that it is recalling certain batches of Tixylix®, paediatric liquid cough and cold medicines, because of a potential manufacturing defect with the tamper seal that could result in small pieces of plastic being found in the bottles.
Whilst no pieces of plastic have been found in Tixylix® medicines and the potential occurrence of this defect is very low, as a precaution, we are recalling the batches from consumers, retail customers and wholesalers in the UK. Cough and cold remedies for children under two are to be pulled from the shelves immediately amid safety fears.
A?100m worth over-the-counter cough medicines are sold each yearIt could signal a return to old-fashioned remedies such as honey and lemon drinks. 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. 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 if suspected adverse reactions have been reported.

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

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 adultsand could harm children. Professor Rosalind Smyth, chairman of the CHM paediatric medicines expert advisorygroup, said last night: "Coughs and colds are generally self-limiting conditions which will get better themselves, usually within a few days.
The Proprietary Association of Great Britain, which represents medicine makers, islaunching an information campaign with leaflets in pharmacies and other shops.

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