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

Gabapentin

Risk to Fetus

In animals. The potential reproductive toxicity of gabapentin has not been adequately evaluated in animals. However, animal reproductive studies in rodents have revealed evidence of fetotoxic effects such as delayed ossification of several bones in the skull, vertebrae, forelimbs, and hindlimbs at oral doses of 1,000 to 3,000 mg/kg/day during organogenesis, which is approximately one to four times the maximum dose of 3,600 mg/day used with epileptic patients when considered on the basis of milligrams per square meter.[135,136] Also, there was an increased incidence of hydroureter and/or hydronephrosis in rats exposed during organogenesis to doses of 2,000 mg/kg/day, which is approximately one to five times the maximum dose of 3,600 mg/day in terms of milligrams per square meter.[135,136] In rabbits, there was an increased incidence of postimplantation fetal loss when exposed to 60, 300, and 1,500 mg/kg/day, which is approximately one fourth to eight times the maximum human dose in terms of milligrams per square meter.[135,136]

In humans. No adequate and well-controlled studies have been done to determine the gabapentin-associated risk to the human fetus.[135,136] Because animal reproductive studies are not always accurately predictive of human response, this drug should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus.

Risk to Infant During Breast-Feeding

We found no published reports of breast-feeding infants exposed to gabapentin. However, one unpublished study conducted by the manufacturer analyzed the blood, urine, and breast milk in six healthy women treated with 400 mg of gabapentin. One woman was unable to produce breast milk. In the other five women, the drug levels in breast milk and plasma were equal.[137] Therefore, caution is advised when gabapentin is administered to mothers nursing infants.

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