Effects of Antimanic Mood-Stabilizing Drugs on Fetuses, Neonates, and Nursing Infants

Mohammad Masud Iqbal, MD, MPH, MSPH, DTM; Sai Prakash Gundlapalli, MD, William G. Ryan, MD, Thad Ryals, MD, Birmingham, Ala; Terry E. Passman, MD, Department of Psychiatry and Behavioral Neurobiology, the Regional Neonatal Intensive Care Unit, and the Department of Epidemiology and International Health, University of Alabama at Birmingham School of Medicine; and the Harbor Unit, Thomas Hospital, Fairhope, Ala

South Med J. 2001;94(3) 

In This Article


Risk to Fetus

In animals. Haloperidol is a conventional antipsychotic agent that readily crosses the placenta in both animals and humans. The potential reproductive toxicity of haloperidol has not been adequately evaluated in animals. However, reproductive studies at doses higher than the recommended human dose have revealed teratogenic effects such as cleft palate, micromelia, and central nervous system and skull malformations.[175,176,177] Fetotoxic effects such as fetal death and decreased fetal and postnatal growth have been reported in rats, mice, and hamsters. Long-lasting alteration of behavior in rats and mice[177,176] and embryotoxic effects such as embryonic death in hamsters[177] have also been reported.

In humans. No adequate and well-controlled studies to determine fetal risk associated with haloperidol have been done. However, Van Waes and Van de Velde[178] conducted a large prospective study of 100 women by administering relatively small doses of haloperidol (0.6 mg) twice daily during pregnancy for the treatment of hyperemesis gravidarum. Of the 100 women tested, 2 were lost to follow-up, 92 received haloperidol during the first trimester, and 6 received haloperidol during the second trimester. The pregnancy outcomes for 98 women, when compared with the controls, showed no apparent effect on fertility, duration of gestation, intrauterine survival, neonatal survival, birth weight, or sex ratio. No malformations were observed in the offspring of treated mothers.[178] However, a separate report describes two cases of severe limb malformation in infants of mothers treated with haloperidol during the first trimester. In one of the infants, the mother received a daily dose of 15 mg during the first 7 weeks of pregnancy. Causal relationships were not established.[179]

Currently available literature does not reveal a causal relationship between haloperidol and teratogenicity, and the risk of a birth defect attributable to haloperidol is low. Therefore, pregnant women may be treated with haloperidol if the benefits to the mother justify a possible risk to the infant.

Risk to Infant During Breast-Feeding

Although haloperidol is significantly excreted in breast milk,[180] no adverse effects in nursing infants have been reported.[181,182] Animal studies have shown that haloperidol excreted in milk causes drowsiness and impairment of motor activity in the breast-fed offspring.[180] Therefore, haloperidol should be used in lactating women only if a risk-benefit assessment justifies the potential risk to the infant.


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