Q: What difference does it make if a medication is specifically approved for use in children or not?

A: Approval of a medication by the FDA means that adequate data have been provided to the FDA by the drug manufacturer to show safety and efficacy for a particular therapy in a particular population. Based on the data, a label indication for the drug is established that includes proper dosage, potential side effects, and approved age. Doctors prescribe medications as they feel appropriate even if those uses are not included in the labeling. Although in some cases there is extensive clinical experience in using medications for children or adolescents, in many cases there is not. Everyone agrees that more studies in children are needed if we are to know the appropriate dosages, how a drug works in children, and what effects there are on learning and development.

Q: What does "off-label" use of a medication mean?

A: Many medications that are on the market have not been officially approved by the FDA for use in children. Treatment of children with these medications is called "off-label" use. For some medications, the off-label use is supported by data from well-conducted studies in children. For instance, some antidepressant medications have been shown to be effective in children and adolescents with depression. For other medications, there are no controlled studies in children, but only isolated clinical reports. In particular, the use of psychotropic medications in preschoolers has not been adequately studied and must be considered very carefully by balancing severity of symptoms, degree of impairment, and potential benefits and risks of treatment.

Q: Why haven't many medications been tested in children?

A: In the past, medications were not studied in children because of ethical concerns about involving children in clinical trials. However, this created a new problem: lack of knowledge about the best treatments for children. In clinical settings where children are suffering from mental or behavioral disorders, medications are being prescribed at increasingly early ages. The FDA has been urging that products be appropriately studied in children and has offered incentives to drug manufacturers to carry out such testing. The NIH and the FDA are examining the issue of medication research in children and are developing new research approaches.

Q: Does the FDA approve medications for different age groups among children?

A: Yes. However, this is based on the data provided to the FDA by the drug manufacturer and the policies in effect at the time of approval. For example, Ritalin® is approved for children age 6 and older, whereas Dexedrine® is approved for children as young as 3. When Ritalin® was tested for efficacy by its manufacturer, only children age 6 and above were involved; therefore, age 6 was approved as the lower age limit for Ritalin®.

Q: Can events such as a death in the family, illness in a parent, onset of poverty, or divorce cause symptoms?

A: Yes. When a tragedy occurs or some extreme stress hits, every member of a family is affected, even the youngest ones. This should also be considered when evaluating mental, emotional, or behavioral symptoms in a child.

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