FDA to Examine Adult Data on Antidepressants
From Times Wire Reports
The Food and Drug Administration will examine clinical trial data for thousands of depressed adults to see whether they, like children, suffered increased suicidal thoughts and behaviors while taking antidepressants.
Dr. Janet Woodcock, acting FDA deputy commissioner, could not say how long the analysis would take or how much it would cost.
A Columbia University analysis of pediatric clinical trial data examined just one-tenth of the information contained in adult databases. That pediatric study -- and the FDA’s own internal reviews -- established a link between antidepressants and children’s worsened conditions.
