NPC Archive Item: Cough and cold medicines withdrawn for children under two years of age

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The Medicines and Healthcare products Regulatory Agency (MHRA) has today announced that certain over-the-counter (OTC) cough and cold products should no longer be used in children under the age of 2 years. This follows a safety review by The Commission on Human Medicines (CHM). The Royal Pharmaceutical Society of Great Britain (RPSGB) has issued a statement urging pharmacists to review cough and cold treatments following this new guidance.

Parents and carers are being advised that children suffering from a cough or cold should be treated with paracetamol, or ibuprofen to lower the child’s temperature and, if they have a cough, to use a simple cough syrup (such as glycerol, honey or lemon). For young babies, who are having difficulty feeding, nasal saline drops are recommended to help thin and clear nasal secretions. Vapour rubs and inhalant decongestants, which can be applied to a child’s clothing, can also be used to provide relief from a stuffy nose. A leaflet for parents and carers about treating coughs and colds in children has been produced.

The CHM took account of experience in the United States (US) where a safety review of children’s cough and cold medicines by the Food and Drug Administration (FDA) revealed a number of serious reports. This will come as no surprise to regular NPC readers because the US review was covered in a previous blog and in the most recent issue of MeReC Extra, No 32 March 2008. The vast majority of these reports involved children under 2 years of age, and in many cases children had been given too much medicine or more than one product containing the same active ingredient. In the UK there have been far fewer reports, but the data does suggest that children under 2 are at greater risk of any potential harm.

The pharmaceutical industry has voluntarily agreed to change the labels on products to remove the dosage instructions for children under 2 years of age, and to add additional instructions in relation to children aged 2-6 years. All affected products are currently being changed, and products with updated packaging and leaflets will be in pharmacies and stores by October 2008.

The cough and cold medicines which will no longer be licensed for children under the age of 2 years, contain the ingredients:

  • brompheniramine, chlorphenamine & diphenhydramine (antihistamines);

  • dextromethorphan and pholcodine (antitussives);

  • guaifenesin and ipecacuanha (expectorants);

  • phenylephrine, pseudoephedrine, ephedrine, oxymetazoline and xylometazoline (decongestants).

The following products directly targeted at children under 2 years of age should be removed from open shelves:

  • Asda Children’s Chesty Cough Syrup [PL 03105/0056 – MAH: Bell’s]

  • Boots Chesty Cough Syrup 1 Year Plus [PL 00014/0381 – MAH: Boots]

  • Boots Sore Throat and Cough Linctus 1 Year Plus [PL 00014/5152R – MAH: Boots]

  • Buttercup Infant Cough Syrup [PL 02855/0022 – MAH: Chefaro]

  • CalCough Chesty [PL 15513/0052 – MAH: McNeil]

  • Children’s Chesty Cough [PL 03105/0056 – MAH: Bell’s]

  • These medicines can still be supplied under the supervision of a pharmacist for older children.

A range of products will remain on general sale for use in children under 2 years old. These include simple cough medicines containing glycerol, lemon or honey.

Single-constituent paracetamol and ibuprofen products are not affected by this advice.

All healthcare professionals, particularly community pharmacists, should be aware of this new safety information and action the advice from the MHRA immediately. The cough and cold products detailed above, which are targeted directly at children under 2 years of age, should be removed from open shelves. Non-prescription cough and cold preparations containing any of the active substances implicated in this review should no longer be sold for use in children under 2 years of age. Children suffering from a cough or cold should be treated with paracetamol or ibuprofen to lower the child’s temperature, and if they have a cough to use a simple cough syrup (such as glycerol, honey or lemon). Cough and cold products can be sold for use in children aged 2 to 6 years as before, but care should be taken to adhere to the maximum daily dose and not to take with other cough and cold medicines.

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