Ensuring Safe and Effective Psychotropic Medications for Children

April 23, 1999 Press Release from National Institute of Mental Health

Up-to-date information on the safety and efficacy of medications for children and adolescents with mental disorders is now available to parents, clinicians, researchers, and policymakers. Presented in a comprehensive series of articles in the May issue of the Journal of the American Academy of Child and Adolescent Psychiatry, new studies show that the most widely prescribed psychotropic medications for children, stimulants and selective serotonin reuptake inhibitors (SSRIs), are safe and effective in the short term for specific conditions, such as attention deficit hyperactivity disorder (ADHD) and obsessive-compulsive disorder. Research results and consensus opinions from leaders who have clinical experience in pediatric psychopharmacology will enable people to make more informed decisions about the safety of these drugs and how they are used.

Until now there have been no systematic studies on the extent of use of all the major classes of psychoactive medications for children and adolescents. Previous studies were limited to specific locations or single institutions, or they focused on a single medication, such as methylphenidate (Ritalin). Addressing this gap, a team from the National Institute of Mental Health (NIMH) analyzed prescribing patterns and drug safety for children younger than 18 years by examining data from the National Ambulatory Medical Care Survey, a survey conducted annually by the National Center for Health Statistics, and the National Disease and Therapeutic Index, a pharmaceutical marketing database, for the year 1995.

"For the first time ever," said Peter S. Jensen, M.D., NIMH Associate Director for Child and Adolescent Research, "we have assembled the latest information on the actual level of all psychoactive medication prescriptions for children, combined these data with current evidence of safety and efficacy, and identified mismatches between clinical practices and scientific evidence." Expert investigators around the country worked together to compile evidence on the safety and efficacy of the entire range of psychoactive medications prescribed for U.S. children and adolescents and to make recommendations for future studies.

The data focused on children’s visits to physicians for psychiatric reasons that involved prescribing a psychotropic medication. Results from the consensus review show good support for the safety and short-term efficacy of stimulants, which were prescribed most to treat ADHD, and for SSRIs, the second most prescribed group of agents, to treat major depression and obsessive compulsive disorder. Tricyclic antidepressants (TCAs) were the third most frequently mentioned, and central adrenergic agonists, such as clonidine, ranked fourth. Jensen and associates contrasted the estimated current use of psychotropics with the scientific evidence. Because many pediatric psychiatric disorders tend to be chronic and require long-term treatment, the study has also helped identify research needs on the long-term effects of these medications.

To advance knowledge of treatment information, NIMH established 7 Research Units on Pediatric Psychopharmacology (RUPPs), a network where clinical studies focus on the effects and safety of psychotropic medications in children. They are: Columbia University, Johns Hopkins University, University of Pittsburgh, Yale University, University of California Los Angeles, Indiana University, and Ohio State University. Through RUPPs, NIMH is studying SSRIs for anxiety in children and adolescents. Also, NIMH will host a conference this summer on the long-term safety of stimulants for ADHD.

"Gathering safety data on psychotropic medications for children is a public health imperative," Dr. Jensen said. The NIMH team’s research results encourage optimism for children with mental illness, their parents, physicians, and all who have a stake in the future of the nation’s children. Recommendations for future research include:

• When possible, practitioners and professional associations should encourage the enrollment of children in responsibly conducted rigorous clinical trials, rather than prescribing medications that have been studied only in adults.

• NIH institutes should target the development of short-term safety and efficacy studies of medications where knowledge is limited, levels of prescribing are highest, and potential for toxicities with long-term exposure are most prominent.
• For companies that voluntarily develop medications for children and adolescents, extension of patent life may help offset the costs of such studies.
• Responsible federal government agencies (FDA, NIH) should ensure that issues related to long-term safety and efficacy of psychotropic agents are systematically examined.

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