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Re: more background on the FDA warning

Posted by Larry Hoover on September 12, 2007, at 11:51:53

In reply to Re: News - Antidepressants Vindicated? » jrbecker76, posted by Larry Hoover on September 12, 2007, at 10:51:00

I just discovered some information that I did not know, about the FDA analysis of the pediatric SSRI trials. It seems that despite screening prior to entry, 29% of subjects were suicidal before the drug trials. Moreover, only spontaneous reports of suicidality were utilized in considering the black box warning.....although only 4% reported such thoughts. In the majority of studies, standard suicidality questionnaires were used, and they revealed a consistent reduction in suicidality during the study period. Induction of suicidality was not observed. :-/


P.S. I unwittingly exaggerated the subject pool for these studies, suggesting there were tens of thousands. In fact, there were about 4400.

The Use of Medication in Treating Childhood and Adolescent Depression: Information for Physicians
Prepared by the American Psychiatric Association (APA) and American Academy of Child and Adolescent Psychiatry (AACAP)

"What Prompted the FDA Warning?

In 2004, the FDA reviewed 23 clinical trials involving more than 4,300 child and adolescent patients who received any of nine different antidepressant medications. No suicides occurred in any of these studies. Most of the studies that the FDA examined used two measures to assess suicidal thinking and behavior.

1) All used "Adverse Event Reports," which are reports made by the research clinician if a patient (or their parent) spontaneously shares thoughts about suicide or describes potentially dangerous behavior. The FDA found that such “adverse events” were reported by approximately 4% of all children and adolescents taking medication compared with 2% of those taking a placebo. One of the problems with using this approach to measuring suicidal thinking is that most teenagers do not talk about their suicidal thoughts unless they are asked, in which case no report is filed.

2) In 17 of the 23 studies a second measure was also available. These were standardized forms asking about suicidal thoughts and behaviors completed for each child or teen at each visit. In the views of many experts these measures are more reliable than event reports. The FDA's analysis of the data from these 17 studies found that medication neither increased suicidality that had been present before treatment, nor did it induce new suicidality in those who were not thinking about suicide at the start of the study. In fact, on these measures, all studies combined showed a slight reduction in suicidality over the course of treatment. Although the FDA reported both sets of findings, they did not comment on the contradiction between them.Hence, the 2% and 4% spontaneous report rates need to be understood in the context of findings from community samples cited previously in which as many as half or more of teenagers with major depression are thinking about suicide at the time of diagnosis and some 16% to 35% have made a previous suicide attempt.

Although only nine medications were re-examined in the analysis, the FDA applied the labeling changes to all antidepressant medications. This was done on the basis of the advisory committee’s perception that currently available data are inadequate to exclude any single medication from being potentially associated with the same increased risk for spontaneous reports of suicidal thinking and/or behavior found in the 23 studies."




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