Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.The UK's MHRA has issued a clarification notice to clear the ambiguities concerning the cough and cold medicines for infants. The notice stated that the cough and cold medicines for infants are not being withdrawn from the market, according to PJB news.
Subscribe to our email newsletter
The MHRA requested the withdrawal of six products that are directly aimed at children under two years. But these products can be made available to older children at the pharmacist’s discretion. The MHRA also said that the majority of products for children under six years can remain on the market and be sold as before.
The Commission on Human Medicines advised the MHRA on these medicines after taking into consideration the findings from a US safety review which revealed many cases of accidental overdosing in infants. Medicines containing the antihistamines brompheniramine, chlorphenamine and diphenhydramine; the antitussives dextromethorphan and pholcodine; the expectorants guaifenesin and ipecacuanha and several decongestants, including phenylephrine and pseudoephedrine will no longer be licensed for use in infants.
According to MHRA, children who are suffering from colds should be treated with paracetamol or ibuprofen to control fever and those with coughs should be given simple cough syrups. The pharmaceutical industry has also agreed to alter the labels on products to remove the dosage instructions for children under two years. Products with the updated advice on their labels and in information leaflets are expected to be available by October, 2008.