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. Animal reproductive studies have shown evidence of teratogenic effects such as craniofacial anomalies (at an oral dose of 20, 100, or 500 mg/kg) and skeletal anomalies (at doses of 500 mg/kg) in mice, limb malformations in rats (ectrodactyly, micromelia, and amelia) at doses of 400 mg/kg or greater, and rib and vertebral malformations in rabbits at doses of 120 mg/kg when given during the period of organogenesis. Fetotoxic effects such as decreased fetal weight and increased incidence of structural variations in mice, rats, and rabbits and embryotoxic effects in rabbits have been found to be associated with its use at doses higher than the recommended human dose.[135,136,141] In addition, clinical signs of maternal toxicity and decreased maternal body weight gain were seen among pregnant rats and rabbits at doses ranging from 35 to 400 mg/kg or greater.[135,136,141]

In humans. No well-controlled studies using topiramate in pregnant women have been done.[136,141] Therefore, topiramate should be used during pregnancy only if the potential benefit outweighs the potential risk to the mother and fetus.

Risk to Infant During Breast-Feeding

Topiramate is excreted in the milk of lactating rats.[136,137,141] It is not known whether topiramate is excreted in human milk. Since many drugs are excreted in human milk and because the potential for serious adverse reactions in nursing infants exposed to topiramate is unknown, the potential benefits to the mother should be weighed against the potential risks to the infant when considering topiramate therapy.


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