Syrups and other anti-flu medicines should not be given to children who are six years old or younger, a independent advisory panel to the US Food and Drug Administration said Friday.
"The committee expressed concern about the lack of studies that positively demonstrate the benefit of these products for children and they were uncomfortable with the extrapolation of the benefits that have been demonstrated in adults to use these products in children," Doctor John Jenkins, head of the FDA's division that handles new drugs, told reporters.
AdvertisementMembers of the committee "were particularly uncomfortable with the extrapolation for the children under the age of two, and overall, they want to see studies in children to demonstrate the benefit of these products in children," Jenkins said.
He pointed out that reports of serious adverse events have been very rare over the long market history, and many of the cases reported have been with association with overdose or missuses of the product.
Last week, the Consumer Healthcare Products Association, a pharmaceutical industry group, announced that manufacturers were voluntarily recalling 14 leading over-the-counter oral infant cough and cold medicines.
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