Poll: Most Parents Want Kids to Only Get Drugs Approved for Kids, but That Rules Out Many Medications
By Miranda Hitti
WebMD Medical 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."
By Miranda Hitti
WebMD Medical 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."
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