More tests urged on colds medicines
Section: Health
Andrew Bridges, Associated Press Writer
WASHINGTON - Widely used cold and cough medicines have not been shown to work in anyone younger than 12, government health advisers said Friday, in urging the over-the-counter drugs be studied directly in children.
"The data that we have now is they don't seem to work," said Sean Hennessy, a University of Pennsylvania epidemiologist, one of the Food and Drug Administration experts gathered to examine the medicines, used billions of times a year to treat common cold symptoms.
The final recommendations are likely to lead to a shake up in how the medicines — sold for decades without much scrutiny — are labeled, marketed and used. The Thursday-Friday meeting came just a week after the drug industry moved to eliminate sales of the nonprescription drugs targeted at children under 2.
Pediatricians pushing for greater restrictions told the FDA advisers Thursday that the over-the-counter medicines shouldn't be given to children younger than 6, an age group they called the most vulnerable to any potential ill effects.
The 22 voting panelists were to recommend later Friday if the drugs simply shouldn't be used in some age groups. The FDA isn't required to follow the advice of its panels of outside expert but does so most of the time.
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. It argues that more parent education is needed to avoid overdoses that in rare cases have been fatal.
A group of pediatricians petitioned the FDA earlier this year seeking action on the medicines. The FDA called the meeting to answer a basic question: Are the medicines safe and do they work in the very young?
An American Academy of Pediatrics official told the experts the medications should be relabeled to tell parents they don't work in children under 6 and may be dangerous.
"Why not label these products with what we actually know?" asked David Bromberg, a Frederick, Md., pediatrician.
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 that the medicines worked in those cases, according to the agency.
For the most part, the results from tests in adults have been extrapolated to determine whether the medicines work in children. But even that evidence is "modest at best," said panel chairwoman Dr. Mary Tinetti of Yale University School of Medicine. Indeed, all but one of the 22 panelists then voted to say that extrapolation is unacceptable.
The panelists later voted unanimously to recommend the medicines be studied in children directly to determine whether they work. That recommendation would require the FDA to undertake a rule-making process to reclassify the medicines, since the ingredients they include are now generally recognized as safe and effective, which doesn't require testing. That process can take years, even before any studies themselves get under way.
Simply relabeling the medicines to state they shouldn't be used in some age groups could be accomplished more quickly, FDA officials said.
Later Friday, the panel also was 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 that children catch five to eight colds each year. The frequent and normal symptoms of those colds don't necessarily require treatment beyond comfort measures that don't 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.
