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Safety of antipsychotic drugs for pregnant and breastfeeding women with non-affective psychosis

BMJ 2004; 329 doi: (Published 21 October 2004) Cite this as: BMJ 2004;329:933

This article has a correction. Please see:

  1. Louise Howard (, senior lecturer,
  2. Roger Webb (, research fellow,
  3. Kathryn Abel (, senior lecturer
  1. Health Services Research Department, Institute of Psychiatry, London SE5 8AF
  2. Centre for Women's Mental Health Research, University of Manchester, Manchester M13 9PL

    Multicentre cohort studies are needed as randomised trials are impractical

    Around 2% of women develop a non-affective psychotic disorder, and more than half of them have children.1 2 Women with nonaffective psychoses are less fertile than controls, partly because of hyperprolactinaemia secondary to antipsychotic drugs.3 4 The use of atypical drugs such as clozapine and olanzapine, which do not have this effect, may increase fertility rates. Weighing risks against benefits in treating pregnant and breastfeeding women with antipsychotics requires assessment of clinical effectiveness versus risk of toxicity to mother, fetus, newborn, and the developing child. Withholding antipsychotic treatment may expose mother and fetus to more harm than benefit as, in addition to behavioural disturbance which may put both at risk, physiological changes associated with psychosis could affect fetoplacental integrity and development of the central nervous system. Subsequently, poor clinical outcomes for mothers may result in poorer interaction between mother and infant.5 But the impact of antipsychotic medication on the fetus is also unclear as no randomised controlled trials have evaluated the use of antipsychotics in pregnancy.6

    The only large controlled studies of antipsychotics in pregnancy have been conducted on …

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