our logo
Freedom is in you...
You are enough. You are your solution.  
Go Back   paxilprogress > Paxil > News / Research / Articles / Books
User Name
Password
Register Moderation Guidelines Members List Calendar Search Today's Posts Mark Forums Read

News / Research / Articles / Books Helpful resources for books, news, research and more. If you find a book article or research paper interesting, mention it here please.

Adverse Drug Reaction Reporting    FDA Warnings    Published Withdrawal Studies    Pregnancy Warnings    Forum Psychology

Reply
 
Thread Tools
Old 03-03-2005, 10:38 PM   #1
elisa
 
elisa's Avatar
 
Join Date: Jul 2004
Location: Ontario, Canada
Posts: 11,470
Psychiatry's response to Black Box Warnings

http://pn.psychiatryonline.org/cgi/c...short/40/5/1-a

Here's an excerpt of that article:

In the final version of the warning, the first sentence in the black box has changed. The October draft's sentence initially read: "Antidepressants increase the risk of suicidal thinking and behavior (suicidality) in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders." The revised sentence limits the association between the two, more narrowly defining its scope. The sentence now reads: "Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders."

The change may be subtle, but it is significant. Even more significant is the deletion of a sentence from the first paragraph of text in the "WARNINGS-Clinical Worsening and Suicide Risk" section of the label. The draft warnings posted by the agency last October read: "A causal role for antidepressants in inducing suicidality has been established in pediatric patients." That sentence has been deleted from the final version of the new label and replaced with "Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders."
__________________
On A/D's since 1995, switching due to side-effects on 30 different brands of TCA's, SSRI's, SNRI's, Antipsychotics, Benzo's & Imovane. 6 ECT's. Tapering from 225 mg Effexor XR May 17, 2004. (Equiv. to 60 mg Paxil) Last taper Effexor XR Jan 17, 2006 down to ZERO. Currently protracted withdrawal. Sept 2006: 25 mg Doxepin. March 13/09: 10 mg Desipramine
elisa is offline   Reply With Quote
Reply


Currently Active Users Viewing This Thread: 1 (0 members and 1 guests)
 
Thread Tools

Forum Jump


All times are GMT -6. The time now is 02:56 PM.


We are not in any way affiliated with Paxil's manufacturer GlaxoSmithKline.
Our ideas and suggestions are anecdotal, inspirational, and they work.

Get the best web browser, FireFox

Powered by vBulletin® Version 3.6.5
Copyright ©2000 - 2014, Jelsoft Enterprises Ltd.