When’s the last time you asked your doctor if the medication prescribed for your child is FDA (U.S. Food and Drug Administration) approved?

If you are like most parents, you probably fall into the 83 percent that believe their child’s last prescription was approved for use in children by the U.S. Food and Drug Administration, when surprisingly, less than 30 percent actually are.

The news comes from a recently published report by the University of Michigan C.S. Mott Children’s Hospital National Poll on Children’s Health.

That’s a pretty big differential, which begs parents to question what is going on with our kids’ medications.

Behind the label
FDA labeling is very important to parents, indicating that the medicine in question has been clinically tested in children, says Dr. Matthew M. Davis, M.D, M.A.P.P, director of the National Poll on Children’s Health.

“But that’s a problem when there are many fewer studies done on medicines in children,” he said in a recent phone interview. “So when there is a lack of studies in a particular patient group, like children, the FDA cannot issue formal approval.”

The solution is to either get more medicines approved or to encourage doctors and parents to negotiate situations when the physician wants to use medicine that are safe and effective, even if it has not received FDA approval, says Davis.

The National Poll reveals
For the report, the National Poll on Children’s Health used data from a national online survey conducted from December 2007 through January 2008. The survey was administered to a random sample of over 2,000 adults ages 18 and over, with about three-fourths of sample households having children.

The issue, says the report, has grown as more and more children are prescribed medications for chronic medical conditions such as asthma, high blood pressure, and attention deficit hyperactivity disorder, or ADHD.

Results from the poll indicate that:

• 94 percent of parents believe it is the responsibility of the doctor to tell them if prescribed medicines are FDA approved for use in children.

• Women are more likely than men to want their doctor to prescribe medicines with pediatric labeling.

• Parents with less education are more likely to want only FDA approved medications for their children.

Davis believes that the current statistics go hand in hand with the increasing need for research involving children.

“Fundamentally, FDA approval…will require more participation by children in medical research,” Davis said in a press release.

Talking with your doctor
So where does this leave you? First of all, don’t run to your medicine cabinet and throw everything away. Instead, take this as a wake-up reminder to feel empowered to ask your doctor questions, such as “Has this medication been granted FDA approval for use in children for this specific medical condition?”

Also, talk with your pharmacist about the safety and effectiveness of medicines, especially since information about pediatric labeling is not always accessible.