FDA panel urges “black box” warning for antidepressantsBMJ 2004; 329 doi: https://doi.org/10.1136/bmj.329.7468.702 (Published 23 September 2004) Cite this as: BMJ 2004;329:702
- Jeanne Lenzer
- Bethesda, Maryland
All antidepressants should come with a “black box” label warning that adolescents treated with the drugs are more likely to become suicidal, according to an advisory panel to the US Food and Drug Administration.
Black box warnings are among the most stringent cautions issued by the FDA and are reserved for drugs with very serious or fatal side effects. The FDA generally follows the recommendations of advisory committees but is less likely to do so when the vote is split, as it was in this case (eight of the 23 expert panellists voted against the warning), said Dr Robert Temple, associate director for medical policy in the FDA's drug evaluation centre.
The surprise vote came after the presentation of new analyses by the FDA during two days of hearings on 13 and 14 September showing that children taking …
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