Black Box Warning on Antidepressants

September 15th, 2004 | Press Releases

Sheila Matthews
National Vice President
www.ablechild.org
(203) 966-8419

Gloria Wright
Vice President State of North Carolina

AbleChild is pleased with the FDA advisory panel’s move to place “black box warnings”, the strongest possible warnings that can be issued, on all antidepressants that have been linked to suicide ideations. The FDA’s hearings appear now to offer hope and healing. During the hearings held February 2 and September 13, frustrated and anguished parents and victims testified as to the horrible acts of violence, suicide, and suicide ideation induced by antidepressant use. According to their testimony, SSRI drugs had the causal effect of perpetrating these terrible tragic reactions on their loved ones. SSRI’s are a class of antidepressants still under investigation for causing suicidal thoughts and acts in children and adolescents. Eight of these SSRI drugs have been banned since last year in the U.K. for anyone under 18 years of age. The FDA never approved the use of these drugs for use in children. These drugs failed to meet the basic FDA requirement for effectiveness, yet were prescribed to children through a loophole called “off label”.

Though this move to place “black box” warnings is long overdue, it is necessary and a welcomed step toward improving the informed consent process. Our organization has regularly requested accountability, which must be required of both the drug companies and the psychiatric industry. There must be a documented informed consent process prior to treatment. Our organization will continue to work with the Congressional Investigation and Oversight Committee and FDA to ensure that the wording on warning labels are clear so there is no chance for misinterpretation.

Misinformation is itself a clear and present danger to the safety of our children. We need to focus closely on ensuring any write-ups regarding risks are straightforward, clear, and are not in any way additional attempts to mislead the public further on the part of drug companies or the psychiatric industry. The decision of the advisory panel to place a “black box warning” on these drugs will go a long way towards reducing the suicide rate in the United States .

Ablechild’s president and co-founder, Patricia Weathers testified before the Advisory Panel, “It broke my heart to see so many senseless deaths. To hide this important information from the public is a deadly secret we cannot afford to keep any longer. These families trusted the psychiatric and drug industries, and that trust was broken.”

AbleChild will attend the Connecticut Statewide Conference on Inclusion in New Canaan , Connecticut , on Saturday, October 2. We will offer the Connecticut Department of Education, parents, children’s advocates, as well as educators access to the latest information on the advisory panel’s recommendations and highlight the importance of “The Child Medication Safety Act” which is still stalled in committee in the Senate. For more information, please visit our website: www.ablechild.org.

Comments are closed.

Website Design by Chroma Sites