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Kids Getting Grown-up Prescriptions?
April 15, 2008 -- Many parents may be surprised to learn that their children's prescriptions may not have specific FDA approval for use in kids.
That's according to the latest installment of the National Poll on Children's Health, a project of the University of Michigan C.S. Mott Children's Hospital.
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The poll, released yesterday, was conducted online in late December and early January. It included 2,131 adults, three-quarters of whom are parents.
At first, 92% of parents polled said they wanted their child's doctor to only prescribe medicines that are approved by the FDA for use in kids.
Then the poll explained that while 95% of medicines have FDA approval for use in adults, 70% to 80% aren't approved by the FDA for use in children. So prescribing only drugs with FDA pediatric approval would knock a lot of drugs off the list of treatment options.
After learning that, 77% of the parents still wanted their child's doctor to only prescribe medicines with the FDA's pediatric labeling.
"About 80% of the parents thought the last medicine their child had been prescribed did have pediatric labeling, which is probably an overestimate on their part," pediatrician and poll director Matthew Davis, MD, MAPP, tells WebMD.
Few Drugs Tested on Kids
Davis points out two reasons why far fewer drugs have FDA approval for use in kids.
"One is that medicines are just more widely used for adults, and so there's even more reason for medicines to be tested for their safety and effectiveness when it comes to adult care," says Davis.
"The second reason," he continues, "is that there are more adults available to do clinical trials. If we're going to have more medicines that do have pediatric labeling, we must be able to somehow get more children and their parents to be involved in clinical trials."
Labeled for Kids?
Grown-up conditions now seen in kids are part of the issue.
"One of the problems we're seeing more commonly in children is high blood pressure, or hypertension," says Davis. "Many of the medicines used commonly to treat high blood pressure in adults do not have pediatric labeling for any age. ... There are some medicines available that do have pediatric labeling, but those aren't necessarily the first-line medicines that doctors would typically reach for."
In other cases, some medicines, such as the asthma drug albuterol or the antibiotic azithromycin, are approved for use in kids of certain ages (ages 2 and older for albuterol and 6 months and older for azithromycin) but may be prescribed for younger children.
"For many medicines that are used commonly, even if they don't have pediatric labeling, we have a strong sense as a profession that we can prescribe them wisely and safely," says Davis. "Where this comes into play is really for newer medicines that may not have been used as widely in children yet and don't yet have FDA labeling. Those are the situations where FDA encouragement for more pediatric trials can be most helpful."
Even if a child gets a grown-up drug, they don't necessarily get a grown-up dose. Doctors often tailor pediatric doses based on children's weight.
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