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66% of Meds Prescribed for Children Not Approved by FDA

Many parents are under the assumption that any medicine prescribed by a health care provider for their child is safe and approved by the U.S. Food and Drug Administration for use in children. But are they right?

Some parents may be surprised to learn that less than one-third of prescription medicines available for kids have formal FDA approval for use in children.

In fact, 83 percent of parents believe that the last medication prescribed for their child was FDA-approved, according to a report released today by the University of Michigan C.S. Mott Children’s Hospital National Poll on Children’s Health. The majority of parents polled also feel that their child’s doctor is responsible for telling them if prescribed medicines are not FDA-approved for use in children.

“FDA labeling is very important to parents, but that’s a problem when only one-third of medicines have FDA approval for use in children,” says Matthew M. Davis, M.D., M.A.P.P., director of the National Poll on Children’s Health. “The solution to that is to either get more medicines that are FDA-approved by increasing clinical studies, or working to help physicians and parents negotiate the situation when physicians want to use medicines that are safe and effective, but may not have FDA approval.”

Not all medicines that are FDA approved for adults are safe and effective for children to use – the dose of medicine, how fast the medicine is processed in the body, and side effects of the medicine can be different for children than for adults.

This issue continues to grow as more and more children take prescription medicines for an increasing number of chronic medical conditions, including asthma, high blood pressure, and attention deficit hyperactivity disorder, or ADHD.

Although doctors can prescribe medicines off-label for children – medicines without FDA approval for children – the National Poll on Children’s Health shows that the majority of parents (77 percent) want their child’s doctor to prescribe only medicines that are FDA-approved for use in children.

The National Poll on Children’s Health reveals:

  • 94 percent of parents believe it is the doctor’s responsibility to tell them if their child’s medicine is not FDA-approved for use in children.
  • Women are more likely than men to want their child’s doctor to only prescribe medicines with pediatric labeling.
  • Parents with less education are more likely to want only FDA-approved medicine for their children.

Davis says parents’ high level of interest about this issue lends support to current efforts to expand research involving children.

“Fundamentally, FDA approval for a great number of medicines will require more participation by children in medical research,” explains Davis, associate professor of general pediatrics and internal medicine at the U-M Medical School, and associate professor of public policy at the U-M Gerald R. Ford School of Public Policy. “We know that parents, quite reasonably, may be concerned about having their children in research. That’s one reason why the rate of approval for use of medicine in children is much lower than for adults: there aren’t as many children available for research.”

Talking with your child’s health care provider about FDA-approved meds

Pharmacists as well as doctors can provide families with valuable information about the safety and effectiveness of medicines, especially since information about pediatric labeling is not always easily accessible, says Esther Yoon, M.D., clinical lecturer and member of the Child Health Evaluation and Research (CHEAR) Unit in the U-M Division of General Pediatrics.

First, she says, parents should feel empowered to ask their child’s doctor whether a prescribed medicine is FDA-approved for use in children. “The FDA gives approval for medicines that have been tested for safety and effectiveness for a specific medical condition. Now, if that medicine has also been tested in kids, then the FDA gives it pediatric labeling, which provide information on how doctors should prescribe medicines to kids.”

Doctors, too, play an important role in educating their patients’ families about prescribed medicine. Yoon says doctors should openly discuss with parents if the prescribed medicine is not FDA-approved for use in children, and be prepared to address the reasons behind their choice for medicines that do not have pediatric labeling.

“Studies like the National Poll on Children’s Health provide important information about what parents think and expect from medicines their children are prescribed,” says Yoon. “With better communication between doctors and parents, we have a better chance to improve decision-making for children’s medicines.”

For its report, the National Poll on Children’s Health used data from a national online survey conducted in December 2007 and January 2008 in collaboration with Knowledge Networks Inc. The survey was administered to a random sample of 2,131 adults, ages 18 and older, who are a part of Knowledge Network’s online KnowledgePanelSM. The sample was subsequently weighted to reflect U.S. population figures from the U.S. Census Bureau. About three-fourths of the sample were households with children.

For the complete report and podcast about poll results, visit the C.S. Mott Children’s Hospital National Poll on Children’s Health online at http://www.med.umich.edu/mott/research/chearnpch.html.

The C.S. Mott Children’s Hospital National Poll on Children’s Health – funded by the Department of Pediatrics and Communicable Diseases and part of the CHEAR Unit at the U-M Health System – is designed to measure major health care issues and trends for U.S. children.

To learn more about Knowledge Networks, visit http://www.knowledgenetworks.com.


University of Michigan Health System Released: Mon 14-Apr-2008

Key concepts: prescription drugs, off-label use, children