The American Academy of Child and Adolescent Psychiatry (AACAP) and the American Psychiatric Association (APA) pledged to work with the Food and Drug Administration (FDA) Drug Safety and Risk Management Advisory Committee on determining the prevalence of rare, unexpected, and serious adverse events that occasionally occur in clinical trials for medications used in the treatment of children and adolescents with Attention Deficit Hyperactivity Disorder (ADHD).
Child and adolescent psychiatrist Laurence Greenhill, M.D. testified today on behalf of the AACAP and APA and said, "Stimulant medications offer many benefits to a wide range of children, and have proven to be safe over a half-century of use." The AACAP and the APA are committed to working with the FDA to strengthen safeguards for the treatment of children and adolescents with ADHD. To access Dr. Greenhill's full testimony, please visit the AACAP's website at http:// aacap.
ADHD is one of the most common psychiatric disorders in children and adolescents. The Centers for Disease Control and Prevention estimates that approximately 3,500,000 youth in the United States are taking stimulants as part of their treatment plan. Although medication is not the only treatment option, it can be an important part of a treatment plan for a child with ADHD. Large-scale, long-term, randomized clinical trials show the efficacy of long-term medication treatment and the important role of psychosocial interventions. Research demonstrates that medication can be extremely effective and even lifesaving for many children and adolescents with ADHD, and is most beneficial when used as a component of a comprehensive treatment plan. Medication allows many children with ADHD to sit and concentrate in class and lessens the likelihood of rejection by peers.
ADHD medications constitute the largest group of medications approved for use by the FDA for the treatment of children with behavioral problems. Stimulant medications are some of the most extensively studied medications used for the treatment of behavior disorders in children and adolescents. There have been over 200 controlled studies over the past 50 years. These drugs produce robust responses in over two thirds of affected youth by lowering the intensity of their ADHD symptoms.
The AACAP and APA realize the importance of identifying rare, unexpected adverse events and determining their prevalence. Only then can the partnership of parent and practitioner make an informed decision regarding the benefit-risk ratio involved in starting medication treatment. Besides the physiological risks of taking medications, alternatively, not treating ADHD can lead to possible school failure, substance abuse and increased probability of entrance into the juvenile justice system, if not treated appropriately.
The AACAP and APA are committed to working with the FDA to determine the prevalence of rare, unexpected, and serious adverse events to better estimate risk for taking these medications. The Child and Adolescent Psychiatry Trial Network (CAPTN), sponsored by NIMH and AACAP, is a large simple trials network and is one avenue to study these issues. This practice network will provide protocol-driven, postmarking surveillance for youth treated with ADHD medications to track such low frequency adverse events prospectively.
The AACAP and the APA have recommended to Congress and the FDA the formation of a pediatric and adolescent Central Nervous System Advisory Committee comprised of experts including child and adolescent psychiatrists and pediatric neurologists which would provide the agency expertise on pediatric psychopharmacology. The AACAP has been a long-standing advocate on behalf of a publicly accessible national registry of clinical trials. Physicians and parents need access to all clinical trial data to make fully informed decisions about their treatment options for all mental illnesses. Finally, the shortage of pediatric mental health clinicians and researchers are needed to appropriately diagnose and treat children and adolescents with mental illnesses and we urge support for legislation to address this shortage.
To view the Food and Drug Administration's Drug Safety and Risk Management Advisory Committee Feb. 9-10, 2006 briefing information, click here.
http:// aacap
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