The American Academy of Child and Adolescent Psychiatry urges the U.S. Food and Drug Administration (FDA) to consider all data available before placing a stronger warning on antidepressant medication for the adult population. Such a severe advisory could dissuade depressed individuals from seeking treatment.
For Immediate Release
Stronger Warning Could Have Far Reaching, Negative Impact
Washington, D.C. -The American Academy of Child and Adolescent Psychiatry urges the U.S. Food and Drug Administration (FDA) to consider all data available before placing a stronger warning on antidepressant medication for the adult population. Such a severe advisory could dissuade depressed individuals from seeking treatment.
The FDA's Psychopharmacologic Drugs Advisory Committee will meet on Wednesday, December 13 to review recent data from adult suicidality trials and to determine whether stronger warnings should be added to consumer labelling.
In late 2004, the FDA placed a black box warning on antidepressants for youth after a review of conflicting data indicated an increase in suicidal thoughts and/or behaviors. The 2005 AMA Report of the Council of Scientific Affairs CSA Report 10-A-05 indicated that "a causal role for antidepressants in increasing suicides in children and adolescents has not been established." In addition, Robert Gibbons, Ph.D., et al’s study published last month in the American Journal of Psychiatry shows that the increased prescription of antidepressants correlates to a decrease in suicide on a county-by-county basis.
"Depression is a pervasive illness that can cause severe impairment, but can be successfully treated, especially with early intervention. The AACAP supports access to quality treatment, which can include medication, talk therapy, or optimally, a combination of the two," says AACAP President Thomas F. Anders, M.D.
The AACAP is supportive of the FDA's practice of approving safe and effective treatment for individuals with mental illnesses. However, while protecting and informing the public, the AACAP urges the FDA to balance the impact of stronger warnings on current practice and the demonstrated effectiveness of antidepressants to treat individuals with depression.
Allied mental health organizations, including the AACAP, will hold a press conference at noon at the Hilton Washington, D.C./Silver Spring, The Maryland Ballroom, 8727 Colesville Rd., Silver Spring, MD. For more information, please contact AACAP Communications Manager Erin Baker at email@example.com.
AACAPs Testimony to the FDA on SSRI Hearing*
Mental Health Advocacy and Professional Organizations Sign Open Letter to FDA*
Press Briefing Media Advisory*
Christopher Kratochvil, M.D.'s Testimony from FDA hearing on December 13, 2006*
Open Letter on Antidepressants*
Open Letter Media Release*
*denotes Adobe PDF File
Click here to download the free Adobe Reader for PDF files
Representing over 7,500 child and adolescent psychiatrists nationwide, the American Academy of Child and Adolescent Psychiatry (AACAP) is the leading authority on children’s mental health. AACAP members actively research, diagnose, and treat psychiatric disorders affecting children, adolescents, and their families.
The American Academy of Child and Adolescent Psychiatry (AACAP) is the leading authority on children’s mental health. AACAP members actively research, diagnose, and treat psychiatric disorders affecting children, adolescents, and their families.
Our Facts for Families, available free of charge on the AACAP website, provide concise and up-to-date information on a wide array of issues relating to children’s mental health. Written in a simple, straightforward manner, these 88 one-page fact sheets are valuable to anyone raising or working with children. In addition, the AACAP routinely refers the media to expert spokespeople on child and adolescent issues, and sponsors The Campaign for America’s Kids – an initiative designed to fund an Advocacy Institute for Child and Adolescent Mental Health, with the goal of mental health for all children.
AACAP Mission: The Mission of the AACAP is the promotion of mentally healthy children, adolescents and families through research, training, advocacy, prevention, comprehensive diagnosis and treatment, peer support and collaboration.