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Secret US report surfaces on antidepressants in children

BMJ 2004; 329 doi: https://doi.org/10.1136/bmj.329.7461.307 (Published 05 August 2004) Cite this as: BMJ 2004;329:307
  1. Jeanne Lenzer
  1. New York

    Internal memos and a secret government report about the negative effects of antidepressants in children—suppressed by the US Food and Drug Administration—have surfaced publicly.

    The Alliance for Human Research Protection, a national network dedicated to ensuring ethical standards in medical research, published the documents on 26 July.

    The published documents confirm earlier news accounts that a government expert with the FDA's Office of Drug Safety, Dr Andrew Mosholder, found that children taking antidepressants were twice as likely to become suicidal as children taking placebo. He reportedly urged the agency to follow the lead of British health authorities by warning doctors that the risks of the newer antidepressants, except fluoxetine, might outweigh the benefits when used in children.

    The leaked documents show his data and conclusions. …

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