SAFETY OF GABAPENTIN TREATMENT DURING PREGNANCY
Abstract number :
2.307
Submission category :
Year :
2002
Submission ID :
3500
Source :
www.aesnet.org
Presentation date :
12/7/2002 12:00:00 AM
Published date :
Dec 1, 2002, 06:00 AM
Authors :
Georgia Montouris. Neurology, The Comprehensive Epilepsy Care Center for Children and Adults, P.C., St. Louis, MO
RATIONALE: The objective of this study was to assess the safety of gabapentin exposure in human pregnancy.
METHODS: Prospective and retrospective data were collected from 51 pregnancy outcomes among 39 women exposed to gabapentin during either a current pregnancy (42 outcomes) or a previous pregnancy (9 outcomes) resulting in 44 live births. Data collected included maternal demographics, diagnosis, treatment, and complications; and fetal complications and outcomes.
RESULTS: The percentage of live births in this study exceeded that seen in the general population (87% vs 62%) with fewer miscarriages (11.3% vs 16%) and abortions (2% vs 22%). The major malformation rate in this cohort was 4.5% (2 of 44 live births). This is slightly above the range seen for the general population (2%-4%). The rate of minor malformations in this group was 2.0% (1 of 44 live births). Overall, in untreated women with epilepsy the range for malformations is (4%-8%) and for treated women with epilepsy (5%-10%). In the general population, the percentage of babies born with very low birth weight (defined as 3 lb 4 oz) is 1.5%, but no babies in this group were born at this weight.
Maternal complications were minimal. Three women experienced complications. The rate of hypertension/eclampsia was 2 in 46 live births (ratio = 0.043), essentially identical to that observed in the general population for hypertension/eclampsia of 44 in 1000 live births (ratio = 0.044). The rate of cesarean section was 10.9%, much lower than the 22.9% seen in the general population.
CONCLUSIONS: Gabapentin exposure during pregnancy did not lead to an increased risk for adverse maternal and fetal events in this study. However, because of the small number of patients examined in this study, additional data from more pregnancies and outcomes are needed.
[Supported by: Pfizer, Inc.]; (Disclosure: Grant - The author has received a research grant for this project from Pfizer, Inc. And is a principal investigator for Pregabalin drug trials for Pfizer, Inc., Consulting - The author serves as a consultant for Pfizer, Inc., Honoraria - The author is a member of a national speakers bureau sponsored by Pfizer, Inc.)