FDA again reviews antidepressants
BMJ 2004; 329 doi: https://doi.org/10.1136/bmj.329.7464.475 (Published 26 August 2004) Cite this as: BMJ 2004;329:475- Janice Hopkins Tanne
- New York
The US Food and Drug Administration is considering tougher warnings about antidepressant drugs in children. The drugs have been linked to almost double the risk of suicide.
The FDA will hold public meetings on the subject in mid-September. Labelling changes and other regulatory actions are possible. The data are not “black and white,” said Dr Thomas Laughren, team leader of psychiatric drug products at the FDA.
In addition, a front page New York Times article headlined “Boy's Murder Case Entangled in Fight Over Antidepressants” noted the FDA's examination of antidepressants in children and adolescents and said the drugs were the subject of a national debate. The article said the drugs might cause …
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