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Questions about Psychotropic Medications for Children Q: Are there situations in which it is advisable to use
psychotropic medications in young children? A: Psychotropic medications may be prescribed for young children with mental, behavioral, or emotional symptoms when the potential benefits of treatment outweigh the risks. Some problems are so severe and persistent that they would have serious negative consequences for the child if untreated, and psychosocial interventions may not always be effective by themselves. The safety and efficacy of most psychotropic medications have not yet been studied in young children. As a parent, you will want to ask many questions and evaluate with your doctor the risks of starting and continuing your child on these medications. Learn everything you can about the medications prescribed for your child, including potential side effects. Learn which side effects are tolerable and which ones are threatening. In addition, learn and keep in mind the goals of a particular treatment (e.g., change in specific behaviors). Combining multiple psychotropic medications should be avoided in very young children unless absolutely necessary. Q: Does medication affect young children differently from older
children or adults? A: Yes. Young children's bodies handle medications differently than older individuals and this has implications for dosage. The brains of young children are in a state of very rapid development, and animal studies have shown that the developing neurotransmitter systems can be very sensitive to medications. A great deal of research is still needed to determine the effects and benefits of medications in children of all ages. Yet it is important to remember that serious untreated mental disorders themselves negatively impact brain development. Q: If my preschool child receives a diagnosis of a mental
disorder, does this mean that medications have to be used? A: No. Psychotropic medications are not generally the first option for a preschool child with a mental disorder. The first goal is to understand the factors that may be contributing to the condition. The child's own physical and emotional state is key, but many other factors such as parental stress or a changing family environment may influence the child's symptoms. Certain psychosocial treatments may be as effective as medication. Q: How should medication be included in an overall treatment
plan? A: When medication is used, it should not be the only strategy. There are other services that you may want to investigate for your child. Family support services, educational classes, behavior management techniques, as well as family therapy and other approaches should be considered. If medication is prescribed, it should be monitored and evaluated regularly. 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 U.S. Food and Drug Administration (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®. Information provided by the National Institute of Mental Health |
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