Ask An Expert / Medication

Is it safe to use medications without FDA approval for children?

Lack of approval doesn't mean they're unsafe or untested

Roy Boorady, MD
Roy Boorady, MD

Senior Director, Psychopharmacology Center

Child Mind Institute

Is it safe to use medications without FDA approval for children?

We’ve come a long way over the last two decades in terms of research in psychopharmacology. But there are still a lot of medications that have not gone through the whole FDA approval process specifically for children. A lack of FDA approval doesn’t mean a drug is unsafe. And it doesn’t mean we can’t use it.

FDA approval means that a medication has been approved as safe and effective for particular conditions and age groups — usually adults. The reality is that we don’t have as many studies of how these medications work in children.

But if a child is experiencing severe distress and dysfunction, and it appears that medication will help, I can’t tell parents they have to come back in 10 years when that drug has gone through the FDA approval process for kids. My obligation is to discuss with them risks and potential side effects of medications, and how we can create the best treatment plan for an affected child.

For example, there are only two medications that are FDA approved to treat depression in adolescents. In some cases, we’ll use medications approved for anxiety in adolescents to treat depression, because we’ve found, in clinical experience, that they can be very effective. It’s not that they’re unsafe; it’s just that their effectiveness hasn’t been systematically evaluated in teens with depression.

Why are there fewer studies involving children? Historically, it has been very difficult to get kids in studies. It’s getting easier now; there has actually been a movement in Congress to help ensure that more kids are involved in studies of psychiatric medications. But lots of families are reluctant to enroll their kids in studies. Studies take time. Families want treatment. They don’t want to worry about whether the child is going to be on an active medication or a placebo.