 News
18th January 2008
Danger of
over the counter cold remediesOver-the-counter cough and cold remedies
can cause "serious and potentially lifethreatening 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. 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." Where to next?
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