Infant Cough And Cold Remedies Taken Off Shelves In UK

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Main Category: Pediatrics / Children's Health
Also Included In: Pharmacy / Pharmacist;  Regulatory Affairs / Drug Approvals
Article Date: 27 Mar 2008 - 3:00 PDT

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The Medicine and Healthcare products Regulatory Agency (MHRA) in the UK has banned the sale of over the counter cough and cold medicines for babies and young children under the age of 2 as a precautionary measure against accidental overdose because of an increase in reports of adverse reactions linked to overdose.

Six of the cough medicines have been banned from the shelves for good and about 100 others may be allowed back on sale over the counter again when they have changed their label warnings to say the remedies should not be given to children under the age of 2, said a report in Times Online.

In the meantime the products will be kept behind the pharmacy counter and will only be sold for use with children over the age of two, and the purchaser will be given a leaflet containing advice about how to give the medicine.

Sara Coakley, spokesperson for the MHRA, told BBC News it was a precautionary measure and the medicines are not dangerous.

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

There was no need to panic, said Coakley, they would not be on the shelves in the first place if they were inherently dangerous.

The alert concerns 12 active ingredients: brompheniramine, chlorphenamine, dextromethorphan, diphenhydramine, ephedrine, guaifenesin, ipecacuanha, phenylephrine, pholcodine, pseudoephedrine, oxymetazoline, and xylometazoline.

According to Times Online, at least 5 deaths of children under the age of two and more than 100 cases of serious adverse events have been linked to cough and cold medicines in Britain.

The danger occurs when a child is given too much of the cough medicine or has more than one at the same time. Small children are more at risk of overdose because of their smaller body size, said the MHRA.

The MHRA is encouraging parents to give their children simple remedies like honey and lemon.

In January this year, a study published in the journal Pediatrics, found that cough and cold medicines were responsible for 7,000 American children a year visiting the emergency department.

The researchers said that most of the admissions were caused by children taking the medicines by themselves, and suggested this was an area to target increased awareness.

This study followed a Public Health Advisory from the US Food and Drug Administration (FDA) that recommended children under 2 are not given over the counter cough and cold medicines because of question marks over their effectiveness and safety.

The US agency said it was also reviewing the case for extending the recommendation for older children after it has completed its review of how the products affect older populations.

Sources: BBC News, Times Online, MNT archives, FDA.

Written by: Catharine Paddock, PhD
Copyright: Medical News Today
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