This daas has long been of the opinion that medicine works because of our belief in the medicine and at other times it works because of doctors, pharma experts' belief in it. Now this news published in Toronto Star proves that most commonly used medicine for kids is totally useless.

Kulbir Singh



WASHINGTON – The medicines long used by parents to treat their children's coughs and colds don't work and shouldn't be used in those younger than six, U.S. federal health advisers recommended Friday.

The over-the-counter medicines should be studied further, even after decades in which children have received billions of doses a year, the outside experts told the Food and Drug Administration. The FDA isn't required to follow the advice of its panels of outside experts but does so most of the time.

"The data that we have now is they don't seem to work," said Sean Hennessy, a University of Pennsylvania epidemiologist, one of the FDA experts gathered to examine the medicines sold to treat common cold symptoms.

The recommendation applies to medicines containing one or more of the following ingredients: decongestants, antihistamines and antitussives. It doesn't apply to expectorants, though many of the medicines also contain that ingredient.

The nonbinding recommendation is likely to lead to a shake up in how the medicines – which have long escaped much scrutiny – are labelled, marketed and used. Just how and how quickly wasn't immediately clear.

"If the agency chose to restrict use in children six and under, that won't necessarily lead to a ban on the products. It might lead to labelling that says `do not use,"' said Dr. John Jenkins, director of the FDA's office of new drugs.

Such labelling changes could take years to put in place, since the FDA would have to undertake a lengthy rule-making process. Jenkins suggested if the drug industry took it upon itself to make such changes, the FDA could use its enforcement discretion to allow it to do so more quickly than would be done otherwise.

In fact, the Thursday-Friday meeting came just a week after the industry pre-emptively moved to eliminate sales of the non-prescription drugs targeted at children under two.

So what are parents to do if they chose to use the medicines, pending further action?

Jenkins recommended they follow the directions when giving the medicines to their children, and use them only as directed. He also counselled they pay close attention to what ingredients the medicines contain and to ask a doctor if they have any questions.

In two separate votes Friday, the panellists said the medicines shouldn't be used in children younger than two or in those younger than six. A third vote, to recommend against use in children 6 to 11, failed.

Health Canada spokesman Alastair Sinclair said the department is aware of the FDA advisory committee's meeting to make recommendations regarding labelling and use of cough and cold products in children.

"Health Canada will consider the results of this meeting as we move forward with our review and recommendations regarding these products," Sinclair said, reading from a prepared statement.

"Health Canada is in the process of reviewing all cough and cold products in Canada to ensure their safe use ... If further regulatory actions are required for safety reasons following this review, Canadians and health-care practitioners will be informed in a timely manner."

No deadline has been set, but Health Canada plans to conduct the review "in the most expeditious manner possible."

Earlier, the FDA panellists voted unanimously to recommend the medicines be studied in children 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. Again, that process could take years, even before any studies themselves get under way.

The panel's advice dovetails with a petition filed by pediatricians that argued the over-the-counter medicines shouldn't be given to children younger than six, an age group they called the most vulnerable to potential ill effects. The American Academy of Pediatrics and other groups back the petition.

But FDA officials and panellists agreed there's no evidence they work in older children, either. Still, panellists held off from recommending against use in those six and older. And some said they feared such a prohibition wouldn't eliminate use of the medicines by parents.

"They will administer adult products to their children because they work for them or feel they work for them," said the panel's patient and family representative, Amy Celento of Nutley, N.J.

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.

"We worked very hard to present data to the panel and in some cases I felt as though they didn't listen and when you are in that position, it's tough," said Linda Suydam, president of the Consumer Healthcare Products Association, the trade group that represents over-the-counter medicines.

Suydam pledged the industry would study the medicines as recommended and try harder to educate parents to avoid overdoses that in rare cases have been fatal.

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.

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 panellists then voted to say that extrapolation is unacceptable.

The panel also recommended drug makers provide standardized droppers with their liquid cough and cold medicines. Experts had told the panel the sometimes hard-to-use dosing devices contribute to parents unwittingly overdosing their children.

- With files from The Canadian Press.