American Academy of Pediatrics announced that cold and cough medications should be relabeled. Parents must know that the medications do not work in children under 6 and may be dangerous.
"Why not label these products with what we actually know?" Dr. David Bromberg, a pediatrician in Frederick, Maryland, told the panel of Food and Drug Administration advisers.
The proposal was just one of many being considered Friday by the outside experts, convened by the FDA to determine whether the widely used over-the-counter medicines are safe and work in young children. The other proposals include an outright ban in marketing the medicines for use in young children and more study of their safety and efficacy in treating colds and coughs.
The drug industry says the medicines, used 3.8 billion times a year in treating cold and cough symptoms in children, do work and are safe, but agrees more parent education is needed to avoid overdoses that in rare cases have been fatal.
Pediatricians pushing for greater restrictions told FDA advisers Thursday that the over-the-counter medicines should not be given to children younger than 6. Such a prohibition would go beyond last week's drug industry move to eliminate sales of the nonprescription drugs targeted at children under 2.
Some of the drugs - which include Wyeth's Dimetapp and Robitussin, Johnson & Johnson's Pediacare and Novartis AG's Triaminic products - have never been tested in children, something flagged as long ago as 1972 by a previous FDA panel. An FDA review found just 11 studies of children published over the last half-century. Those studies did not establish the medicines work in those cases, according to the agency.
The panel also is being asked to examine whether the dizzying array of medicines that combine multiple ingredients and the sometimes hard-to-use droppers included in the packaging contribute to parents unwittingly overdosing their children. Some in the FDA recommend doing away with the combo products and requiring better-designed and standardized dosing devices.
One health expert told the panel children catch five to eight colds each year. The frequent and normal symptoms of those colds do not necessarily require treatment beyond comfort measures that do not involve drugs, said Patricia Jackson Allen, of the National Association of Pediatric Nurse Practitioners.
"Watchful waiting for the normal body defenses to restore health is an appropriate and safe management strategy for the healthy child with the common cold," said Jackson Allen, adding that treatment can mask the symptoms of more serious ailments like asthma.
The panel is expected to provide a recommendation to the FDA late Friday. The agency is not required to follow the recommendations of its advisory panels, but does so most of the time.
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