The FDA rewards drug companies for testing meds. in children

So young and so many pills, more than 25% of kids and teens in the U.S. take prescriptions on a regular basis.

More than a quarter of U.S. kids and teens are taking a medication on a chronic basis, according to Medco Health Solutions Inc., the biggest U.S. pharmacy-benefit manager with around 65 million members. Nearly 7% are on two or more such drugs, based on the company's database figures for 2009.

Doctors and parents warn that prescribing medications to children can be problematic. There is limited research available about many drugs' effects in kids. And health-care providers and families need to be vigilant to assess the medicines' impact, both intended and not. Although the effects of some medications, like cholesterol-lowering statins, have been extensively researched in adults, the consequences of using such drugs for the bulk of a patient's lifespan are little understood.

Many medications kids take on a regular basis are well known, including treatments for asthma and attention-deficit hyperactivity disorder.

But children and teens are also taking a wide variety of other medications once considered only to be for adults, from statins to diabetes pills and sleep drugs, according to figures provided to The Wall Street Journal by IMS Health, a research firm. Prescriptions for antihypertensives in people age 19 and younger could hit 5.5 million this year if the trend though September continues, according to IMS. That would be up 17% from 2007, the earliest year available.

Most medications that could be prescribed to children on a chronic basis haven't been tested specifically in kids, says Danny Benjamin, a Duke University pediatrics professor. And older drugs rarely get examined, since pharmaceutical firms have little incentive to test medicines once they are no longer under patent protection.

Still, a growing number of studies have been done under a Food and Drug Administration program that rewards drug companies for testing medications in children. In more than a third of these studies, there have been surprising side effects, or results that suggested a smaller or larger dose was needed than had been expected, Dr. Benjamin says. Those findings underscore that children's reactions to medicines can be very different than those of adults. Long-term effects of drugs in kids are almost never known, since pediatric studies, like those in adults, tend to be relatively short.

"We know we're making errors in dosing and safety," says Dr. Benjamin, who is leading a new National Institutes of Health initiative to study drugs in children. He suggests that parents should do as much research as they can to understand the evidence for the medicine, confirm the diagnosis, and identify side effects. Among the places to check: drug labels and other resources on the FDA's website, published research at www.pubmed.gov, and clinical guidelines from groups like the American Academy of Pediatrics.
http://online.wsj.com/article/SB10001424052970203731004576046073896475588.html?mod=WSJ_article_MoreIn_Health

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