To provide information regarding the effects of in utero exposure to gabapentin, physicians are advised to recommend that pregnant patients taking gabapentin enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry.
This can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves. Information on the registry can also be found at the website http://www.aedpregnancyregistry.org/. Limited observations have suggested an active transplacental transport of gabapentin, with accumulation in the fetus as a consequence.
Gabapentin has been assigned to pregnancy category C. Animal studies have revealed evidence of fetotoxicity involving delayed ossification in several bones of the skull, vertebrae, forelimbs and hindlimbs. Hydroureter and hydronephrosis have also been reported in animal studies. There are no controlled data in human pregnancy. Gabapentin should only be given in pregnancy when benefit outweighs risk.
Gabapentin Breastfeeding Warnings
Gabapentin is secreted into human milk following oral administration. A nursing infant may be exposed to a maximum dose of approximately 1 mg/kg/day of gabapentin. Because the effect on the nursing infant is unknown, gabapentin should be used in women who are nursing only if the benefits clearly outweigh the risks.