FDA hearings confirm risks of antidepressantsBMJ 2004; 329 doi: https://doi.org/10.1136/bmj.329.7467.641 (Published 16 September 2004) Cite this as: BMJ 2004;329:641
- Jeanne Lenzer
- Bethesda, Maryland
Testimony presented by experts at the first day of hearings held by the US Food and Drug Administration confirmed that depressed children who are treated with antidepressants are more likely to harm themselves than depressed children treated with placebo.
The hearings are being held jointly by the Psychopharmacologic Drugs Advisory Committee and the Pediatric Advisory Committee. Preliminary risk data on the use of antidepressant drugs in paediatric patients were presented at a joint meeting of two FDA committees on 2 February. Since that meeting, experts in suicidal behaviour in children assembled by Columbia University have independently classified the risks and the FDA has conducted an analysis of these data. …