Over-the-counter cough and cold remedies 'could be fatal for toddlers and babies'

Over-the-counter cough and cold remedies can cause "serious and potentially life-threatening side-effects" in young children, drug experts warned last night.

America's Food and Drug Administration said the remedies should not be given to toddlers under the age of two because of safety fears.

The regulator, which provides safety information on medicines, said its warning followed reports of deaths, convulsions and rapid heart rates among children given overdoses.

Dr Charles Ganley, director of the FDA's Office of Non-Prescription Products, said: "The FDA strongly recommends to parents and caregivers that OTC cough and cold medicines not be used for children younger than two.

"These medicines, which treat symptoms and not the underlying condition, have not been shown to be safe or effective in children under two."

The body representing UK drugs companies confirmed that some of the ingredients causing concern in America were found in best-selling British products - including some brands of Tixylix, Benylin and Calpol.

However, it stressed that none had been shown to be dangerous when used correctly and that parents could continue to use them with confidence if they followed the instructions closely.

Concerns have been growing in America about over-the-counter children's medicines. Last year, the American College of Chest Physicians said cough mixtures were of little use to adults and could harm children.

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The FDA's warning covers products including cough suppressants for the treatment of colds, decongestants, expectorants and antihistamines.

The agency has yet to rule whether the medicines are safe for children aged two to 11.

There is most concern over the risks posed by concentrated medicines which use droppers or films placed under a child's tongue.

The Proprietary Association of Great Britain - which represents manufacturers of over-the-counter medicines - said these were not sold in Britain.

It said only a handful of cough and cold remedies on sale in the UK and labelled as suitable for under-twos contained the ingredients reviewed by the FDA as potentially dangerous.

They are: Chesty Coughs, Colds And Coughs, Night Coughs (all from the Benylin Children's range), Calcold, Calpol Night, Medised For Children, Robitussin Chesty Cough Medicine, Tixylix Cough And Cold and Tixylix Chesty Cough.

Sheila Kelly, chief executive of the PAGB, said: 'The review of the medicines in the United States was triggered by safety concerns due mainly to parents giving incorrect doses.

"When taken in the right doses, there is very little potential for children's cough and cold remedies to cause harm in children.

"Parents faced with a child who is suffering from cough and cold symptoms know how distressing it can be.

"Having access to safe and effective children's cough and cold remedies is essential."

A spokesman for the Government's Medicines and Healthcare products Regulatory Agency said: "If giving a child more than one medicine, parents should take care that they do not contain the same active ingredient or that the maximum recommended dose for that drug is not exceeded."