BMJ  2004;329:816 (9 October), doi:10.1136/bmj.329.7470.816-b

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FDA to review risks of antidepressants in adults

New York

The first 150 words of the full text of this article appear below.

The US Food and Drug Administration (FDA) announced last week that it will examine whether antidepressants pose a similar risk of increased suicidal thoughts among adults as they do for children, by reanalysing data for adults.

"Our first priority with regard to the adult data is to finish our analysis of the adult completed suicides data, and get this published," said a spokesperson for the FDA's Center for Drug Evaluation and Research. The spokesperson told the BMJ that the FDA has also been asked to look at suicidal "ideation and behaviours" contained within the "various antidepressant [new drug applications] submitted in recent years."

"Such data were looked at as part of the [new drug application] submissions and reviews, and no signal [evidence of increased suicidal thoughts] was found," said the spokeswoman. Janet Woodcock, acting director of the FDA, said that the analyses will be a "huge undertaking."

Currently, only about . . . [Full text of this article]

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