FDA accepts weakened antidepressant warning

BMJ 2005; 330 doi: (Published 17 March 2005) Cite this as: BMJ 2005;330:620
  1. Jeanne Lenzer
  1. New York

New “black box” warnings will appear this month in the United States on antidepressant labels about the risk of increased suicidality among children using the drugs. The warnings initially advised by the US Food and Drug Administration, however, have been weakened by industry, say critics.

An FDA advisory panel that met last September (BMJ 2004;329: 702) urged the FDA to demand the new black box warnings. The FDA issued a labelling recommendation in October that read “Antidepressants increase the risk of suicidal thinking and behaviour (suicidality) in children and adolescents with major depressive …

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