What does it mean if a medication is specifically approved for use in children?
When the FDA approves a medication, it means the drug manufacturer provided the agency with information showing the medication is safe and effective in a particular group of people. Based on this information, the drug’s label lists proper dosage, potential side effects, and approved age. Medications approved for children follow these guidelines.
Many psychotropic medications have not been studied in children, which means they have not been approved by the FDA for use in children. But doctors may prescribe medications as they feel appropriate, even if those uses are not included on the label. This is called “off-label” use. Research shows that off-label use of some medications works well in some children. Other medications need more study in children. In particular, the use of most psychotropic medications has not been adequately studied in preschoolers.
More studies in children are needed before we can fully know the appropriate dosages, how a medication works in children, and what effects a medication might have on learning and development.
When the FDA approves a medication, it means the drug manufacturer provided the agency with information showing the medication is safe and effective in a particular group of people. Based on this information, the drug’s label lists proper dosage, potential side effects, and approved age. Medications approved for children follow these guidelines.
Many psychotropic medications have not been studied in children, which means they have not been approved by the FDA for use in children. But doctors may prescribe medications as they feel appropriate, even if those uses are not included on the label. This is called “off-label” use. Research shows that off-label use of some medications works well in some children. Other medications need more study in children. In particular, the use of most psychotropic medications has not been adequately studied in preschoolers.
More studies in children are needed before we can fully know the appropriate dosages, how a medication works in children, and what effects a medication might have on learning and development.
