NAMI - National Alliance on Mental Illness Home | About NAMI | Contact Us | En Espanol  | Donate  
Find
  Advanced Search  
 

Sign In
myNAMI
Communities
Register and Join
Donate
What's New
State & Local NAMIs
Advocate Magazine
NAMI Newsroom
NAMI Store
NAMIWALKS
National Convention
Special Needs Estate Planning
NAMI Travel

 2004
  January
  February
  March
  April
  May
  June
  July
  August
  September
  October
  November
  December

Print this page
Graphic Site
Log Out
 | Print this page | 
 | 

October 15, 2004

FDA Announcement on Black Box Warning Label
for Antidepressants Used With Children

Statement of Kenneth Duckworth, MD
NAMI Medical Director

Providing both doctors and parents with complete information represents sound clinical practice. Discussion of benefits and risks in prescribing any medication or course of treatment is essential.

Close monitoring is appropriate. So too is the need for a clear warning that depression and other psychiatric disorders can have significant consequences, including suicidality, if not appropriately treated.

The FDA’s press release claims that the "new warning language recognizes this need" while advising close monitoring as a way to manage the risk. However, the FDA’s recognition of the risk is NOT included in the actual black box warning language nor clearly stated in other labeling changes. This is a serious omission. Untreated mental illness poses a very real risk of suicide. We know that 80 percent of children today with mental health problem are not getting any treatment. Suicide in fact is the third leading cause of death among young people ages 15 to 24, constituting an even broader public health crisis.

The new labeling also does not recognize that antidepressants combined with psychotherapy represent the most effective course of treatment.

The risk now is that the FDA’s incomplete warning language may simply discourage pediatricians from prescribing antidepressants at all—at a time when there is a severe shortage of child psychiatrists nationwide.

Greater education and training of doctors will be needed, besides greater education and dialogue with parents. Otherwise, the risk of unintended consequences may end up greater than the risks behind the FDA’s action.

# # #


 | Print this page | 
 | 

Donate

Support NAMI to help millions of Americans who face mental illness every day.

Donate today

Speak Out

Inspire others with your message of hope. Show others they are not alone.

Share your story

Get Involved

Become an advocate. Register on NAMI.org to keep up with NAMI news and events.

Join NAMI Today
Home  |  myNAMI  |  About NAMI  |  Contact Us  |  Jobs  |  SiteMap

Copyright © 1996 - 2011 NAMI. All Rights Reserved.