|EMBARGOED FOR RELEASE
Friday, April 23, 1999
5:00 p.m. EST
Ensuring Safe and Effective Psychotropic Medications for Children
- 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.
The articles below appear in a special section of the Journal of the American Academy of Child and Adolescent
Psychiatry, 38:5, May 1999:
"Introduction—Current Knowledge and Unmet Needs in Pediatric Psychopharmacology." Guest Editors: Benedetto Vitiello, M.D., Vinod S. Bhatara, M.D., and Peter S. Jensen, M.D.
"Psychoactive Medication Prescribing Practices for U.S. Children: Gaps Between Research and Clinical Practice," by Peter S. Jensen, M.D., Vinod S. Bhatara, M.D., Benedetto Vitiello, M.D., Kimberly Hoagwood, Ph.D., Michael Feil, M.S., and Laurie B. Burke, R.Ph., M.P.H.
"Critical Review of Tricyclic Antidepressant Use in Children and Adolescents," by Barbara Geller, M.D., Daniel Reising, M.D., Henrietta Leonard, M.D., Mark Riddle, M.D., and B. Timothy Walsh, M.D.
"Nontricyclic Antidepressants: Current Trends in Children and Adolescents," by Graham J. Emslie, M.D., John T. Walkup, M.D., Steven R. Pliszka, M.D., and Monique Ernst, M.D., Ph.D.
"Stimulant Medications," by Laurence L. Greenhill, M.D., Jeffrey M. Halperin, Ph.D., and Howard Abikoff, Ph.D.
"Mood Stabilizers in Children and Adolescents," by Neal D. Ryan, M.D., Vinod S. Bhatara, M.D., and James M. Perel, Ph.D.
"Antipsychotics in Children and Adolescents," by Magda Campbell, M.D., Judith L. Rapoport, M.D., and George M. Simpson, M.D.
"Anxiolytics, Adrenergic Agents, and Naltrexone," by Mark A. Riddle, M.D., Gail A. Bernstein, M.D., Edwin H. Cook, M.D., Henrietta Leonard, M.D., John S. March, M.D., and James M. Swanson, Ph.D.
The National Institute of Mental Health (NIMH) is part of the National Institutes of Health (NIH), the Federal Government’s primary agency for biomedical and behavioral research. NIH is a component of the U.S. Department of Health and Human Services.