Are Your Children's Rx Meds FDA-approved?

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.

Eighty-three 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 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.