Thursday, April 12, 2007

A Closer Look At the FDA's Black Box Warning Enforcement

Here is the FDA's statement and order to drug companies concerned to start letting their consumers know what they didn't for over 15 years - that the drugs they were taking to prevent suicidal thoughts are CAUSING suicidal thoughts - or worse! :
(For the complete posting by the FDA go to

FDA Home Page CDER Home Page CDER Site Info Contact CDER What's New @ CDER
"Labeling Change Request Letter for Antidepressant Medications

[The following language would replace the current language under the WARNINGS-Clinical Worsening and Suicide Risk section.]

WARNINGS-Clinical Worsening and Suicide Risk

Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs.

There has been a long-standing concern that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients.

A causal role for antidepressants in inducing suicidality has been established in pediatric patients.



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