AACAP Urges FDA To Expand Research On ADHD Medications

Main Category: ADHD
Also Included In: Psychology / Psychiatry;  Pediatrics / Children's Health
Article Date: 23 Mar 2006 - 0:00 PDT


Today, at the Food and Drug Administration (FDA) Pediatric Advisory Committee meeting, the American Academy of Child and Adolescent Psychiatry (AACAP) pledged to work with the FDA in communicating to parents and providers any potential risks that may be associated with taking medications for Attention Deficit Hyperactivity Disorder (ADHD). The AACAP is committed to providing comprehensive information to help parents make informed decisions when seeking the best treatment for their child with ADHD.

ADHD is a common childhood psychiatric condition. Its prevalence in the United States is estimated to be between 5 and 7 percent of the school-aged population. Extensive scientific and clinical research has established both the validity of the diagnosis of and treatments of ADHD. These studies have shown the efficacy of psychosocial treatments and medication in treating ADHD. The AACAP Practice Guidelines assist physicians in making the most appropriate treatment decisions for their patients.

The AACAP supports the FDA advisory panel in promoting a better understanding of the safety of medications; however, we are concerned about basing decisions on reports in the FDA's MEDWATCH database. At today's hearing, child and adolescent psychiatrist Dr. Larry Greenhill testified, "some patients in the MEDWATCH database have pre-existing cardiac disease, some patients are on multiple medications, and there is no information on the actual number of patients exposed." As a result, these data should not be used to determine that ADHD medications cause adverse cardiac events. The FDA must weigh the risks of not treating children with ADHD versus the risks of experiencing adverse events associated with medication. Not treating ADHD can possibly lead to school failure, substance abuse, peer rejection, and increased sentencing in the juvenile justice system. Only after additional studies on adverse events to ADHD medications are conducted should the FDA consider a specific threshold of prevalence of adverse events that would require a labeling change for these medications.

The AACAP also recommends the formation of an FDA Central Nervous System Advisory Committee for evaluating safety and efficacy issues in pediatric populations. Membership on this committee should include child and adolescent psychiatrists and pediatric neurologists who would provide needed expertise on pediatric psychopharmacology.

For more information, read Dr. Larry Greenhill's testimony from today's hearing, AACAP's Facts for Families on Children who Can't Pay Attention, AACAP's Policy Statement on Prescribing Psychoactive Medications for Children and Adolescents, and AACAP's Practice Parameter on Assessing and Treating ADHD

American Academy of Child and Adolescent Psychiatry

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