Kids Getting Grown-up Prescriptions?
Poll: Most Parents Want Kids to Only Get Drugs Approved for Kids, but That Rules Out Many Medications
By
Miranda Hitti
WebMD Health News
Reviewed By
Louise Chang, MD
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.
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.
Approved or Not?
Most parents — 94% — indicated in the poll that they think it's the
doctor's responsibility to tell them if their child's medicine doesn't have FDA
approval for use in kids.
"That is going to mean that physicians need to have conversations that
they have not typically been having with parents," says Davis. "As a
result of this poll, I've started having those conversations more regularly
myself with my patients."
"The response has been surprise from parents that I am prescribing
medicines without FDA labeling for children," Davis observes. "But when
I explain that so few medicines do have labeling for children, the parents seem
to appreciate that in pediatrics, we're doing the best we can with limited
information by going on our experience with patients in the past."
Parents should continue to follow all prescriptions, but they should also
feel free to ask their doctors about pediatric labeling, says Davis.
"As a pediatrician myself, I generally recommend to parents that they
get as much information as they can about the medicines that they're giving to
their child. That information includes whether it's been tested enough to have
pediatric labeling from the FDA."
"That labeling information is not always easy to find," says Davis.
"For physicians and parents, that is a challenge that they're going to have
to meet together."
SOURCES: C.S. Mott Children's Hospital, National Poll on Children's Health,
April 14, 2008; vol 3: pp 1-2. Matthew Davis, MD, MAPP, director, C.S. Mott Children's Hospital National
Poll on Children's Health.
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