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No cold remedies for under-twos

22nd January 2008

The United States drug regulator has warned against giving over-the-counter medicines for coughs and colds to children under two years old, citing deaths, convulsions and rapid heart rates in that age group.

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The Food and Drug Administration (FDA) said the medicines were neither safe nor effective for that age group. But it stopped short of extending the warning to children under six years old.

Charles Ganley, head of the FDA office that reviews non-prescription drugs, said serious and potentially life-threatening consequences could result. He said the drugs were only designed to treat symptoms anyway, and were unable to cure a cold.

The medicines are widely sold in the United States, made by companies like Wyeth and Johnson & Johnson.

A ruling is expected in early spring regarding cough and cold medicines in children aged two to 11.

Until now, the FDA had approved the products for use in children using data extrapolated from adults.

But paediatricians say children metabolise and react to medications differently from adults, and their responses are not always predictable.

The medicines have never been endorsed by the FDA for children under two. Last October, pharmaceutical manufacturers pulled 14 cough and cold remedies for children up to age two from the shelves voluntarily.

But they still say the products are safe and effective when used as directed for children age two and older, in spite of a recommendation from a panel of FDA advisers at the same time that the medicines should not be given to children under six.

Experts have petitioned the FDA to restrict the sale of such items for use by children under six years old.

While the controversy has received strong publicity, many parents still felt it was acceptable to give cough and cold medicines to children under two, according to consumer surveys carried out in December.

Officials are urging parents to use only the specific measuring spoons or cups provided with the medicines, and to follow dosing directions carefully, including checking products to make sure they are not duplicating an ingredient in multiple products.

Many problems reported in children with these medicines have resulted from inadvertent overdoses or accidental ingestion.

Diana Zuckerman, president of the National Research Center for Women & Families, said the FDA decision ignored the clear scientific evidence, taking the side of industry against patients.

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