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. Risperidone is a benzisoxazole derivative and an atypical antipsychotic agent that is chemically unrelated to other antipsychotic agents. Evidence indicates that risperidone easily crosses the placenta. Several animal reproductive studies in rats and rabbits have shown no evidence of teratogenic potential at doses higher than the human recommended dose but have shown fetotoxic effects such as increase in pup deaths and a significant increase in the number of stillborn pups.[190]

In humans. No adequate, well-controlled studies to determine teratogenicity of risperidone in gestational women have been done, even though reports of animal fetotoxicity exist. Hence, risperidone should be used during pregnancy only if the potential benefit justifies the possible risk to the fetus.

Risk to Infant During Breast-Feeding

Risperidone and 9-hydroxy-risperidone are excreted into animal milk in concentrations greater than or equal to plasma concentrations.[190] At present, it is not known whether the drug is excreted in human breast milk, though it is suggested that it may cause adverse effects, such as behavior changes, in breast-fed babies.[190] Caution is thus advised when risperidone is administered to lactating women, and nursing infants should be monitored for any adverse changes.


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