gabapentin and Abnormalities, Drug-Induced studies

Gabapentin: A cyclohexane-gamma-aminobutyric acid derivative that is used for the treatment of PARTIAL SEIZURES; NEURALGIA; and RESTLESS LEGS SYNDROME.
gabapentin : A gamma-amino acid that is cyclohexane substituted at position 1 by aminomethyl and carboxymethyl groups. Used for treatment of neuropathic pain and restless legs syndrome.

Abnormalities, Drug-Induced: Congenital abnormalities caused by medicinal substances or drugs of abuse given to or taken by the mother, or to which she is inadvertently exposed during the manufacture of such substances. The concept excludes abnormalities resulting from exposure to non-medicinal chemicals in the environment.

Research Excerpts

Excerpt	Relevance	Reference
"Our objectives were to 1) determine whether first-trimester use of gabapentin is associated with an increased risk for major malformations; 2) examine rates of spontaneous abortions, therapeutic abortions, stillbirths, mean birth weight and gestational age at delivery; and 3) examine rates of poor neonatal adaptation syndrome following late pregnancy exposure."	9.17	Pregnancy outcomes following gabapentin use: results of a prospective comparative cohort study. ( Bernard, N; Einarson, A; Einarson, TR; Etwell, F; Fujii, H; Goel, A; Han, JY; Koren, G; Matsui, D; Pistelli, A; Stephens, S; Yates, LM, 2013)
" We examined the risk of major congenital malformations and cardiac defects associated with gabapentin exposure during the first trimester (T1), and the risk of preeclampsia (PE), preterm birth (PTB), small for gestational age (SGA), and neonatal intensive care unit admission (NICUa) associated with gabapentin exposure early, late, or both early and late in pregnancy."	7.96	Gabapentin in pregnancy and the risk of adverse neonatal and maternal outcomes: A population-based cohort study nested in the US Medicaid Analytic eXtract dataset. ( Bateman, BT; Cohen, JM; Desai, RJ; Hernandez-Diaz, S; Huybrechts, KF; Mogun, H; Patorno, E, 2020)
"Our objectives were to 1) determine whether first-trimester use of gabapentin is associated with an increased risk for major malformations; 2) examine rates of spontaneous abortions, therapeutic abortions, stillbirths, mean birth weight and gestational age at delivery; and 3) examine rates of poor neonatal adaptation syndrome following late pregnancy exposure."	5.17	Pregnancy outcomes following gabapentin use: results of a prospective comparative cohort study. ( Bernard, N; Einarson, A; Einarson, TR; Etwell, F; Fujii, H; Goel, A; Han, JY; Koren, G; Matsui, D; Pistelli, A; Stephens, S; Yates, LM, 2013)
" We examined the risk of major congenital malformations and cardiac defects associated with gabapentin exposure during the first trimester (T1), and the risk of preeclampsia (PE), preterm birth (PTB), small for gestational age (SGA), and neonatal intensive care unit admission (NICUa) associated with gabapentin exposure early, late, or both early and late in pregnancy."	3.96	Gabapentin in pregnancy and the risk of adverse neonatal and maternal outcomes: A population-based cohort study nested in the US Medicaid Analytic eXtract dataset. ( Bateman, BT; Cohen, JM; Desai, RJ; Hernandez-Diaz, S; Huybrechts, KF; Mogun, H; Patorno, E, 2020)
"A total of 60 pregnant mice, divided into 12 groups of five mice each, were exposed to gabapentin in four different doses of 0 (control), 113, 226, or 452 mg/kg body weight per day, at three different gestational stages including early gestation (1-6 days), mid-gestation (7-12 days), and late gestation (13-17 days)."	3.74	Teratogenic effects of the anticonvulsant gabapentin in mice. ( Goel, RK; Madhyastha, S; Nasar, MA; Pai, MM; Prabhu, LV; Rai, R; Singh, G; Yadav, SK, 2008)
" In the last decade, pregnancy registries have been activated by collaborative groups of physicians in Europe (EURAP), North America (NAREP), Australia and India (the latter two recently merged into EURAP), to enroll a large number of exposed women to be monitored prospectively with standardized methods, and by three pharmaceutical companies marketing lamotrigine, gabapentin and vigabatrin, as part of their post-marketing surveillance."	3.71	Pregnancy registries in epilepsy. ( Annegers, JF; Beghi, E, 2001)
" It still remains unclear how much these drugs are safe during pregnancy."	1.51	The neurotoxic effects of prenatal gabapentin and oxcarbazepine exposure on newborn rats. ( Ayas, B; Ercument Beyhun, N; Erisgin, Z; Nyengaard, JR; Terzi, Y, 2019)

Research

Studies (12)

Authors

Clinical Trials (1)

Trial Overview

Trial Outcomes

Baseline Adjusted Mean Daily Motherisk-PUQE Total Scores (Pregnancy-unique Quantification of Emesis and Nausea Scale) for Days 5-7

Timeframe	Studies, this research(%)	All Research%
pre-1990	0 (0.00)	18.7374
1990's	2 (16.67)	18.2507
2000's	4 (33.33)	29.6817
2010's	5 (41.67)	24.3611
2020's	1 (8.33)	2.80

Authors	Studies
Patorno, E	1
Hernandez-Diaz, S	2
Huybrechts, KF	1
Desai, RJ	1
Cohen, JM	1
Mogun, H	1
Bateman, BT	1
Erisgin, Z	1
Ayas, B	1
Nyengaard, JR	1
Ercument Beyhun, N	1
Terzi, Y	1
Fujii, H	1
Goel, A	1
Bernard, N	1
Pistelli, A	1
Yates, LM	1
Stephens, S	1
Han, JY	1
Matsui, D	1
Etwell, F	1
Einarson, TR	1
Koren, G	1
Einarson, A	1
Yüksel, M	1
Sarıkaya, R	1
Bostanci, N	1
Holmes, LB	1
Koo, J	1
Zavras, A	1
Prabhu, LV	1
Rai, R	1
Pai, MM	1
Yadav, SK	1
Madhyastha, S	1
Goel, RK	1
Singh, G	1
Nasar, MA	1
Appleton, RE	1
Tueth, MJ	1
Murphy, TK	1
Evans, DL	1
Iqbal, MM	1
Gundlapalli, SP	1
Ryan, WG	1
Ryals, T	1
Passman, TE	1
Beghi, E	1
Annegers, JF	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
Comparison of Gabapentin and Metoclopramide for Treating Hyperemesis Gravidarum[NCT02163434]	Phase 2	31 participants (Actual)	Interventional	2014-06-30	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Score range: 6-30 with higher score indicating a worse outcome. (NCT02163434)
Timeframe: 1 week

Baseline Adjusted Mean Daily Nausea Scores From the Motherisk-PUQE for Days 5-7.

Intervention	units on a scale (Mean)
Gabapentin	6.35
Metoclopramide	13.22

Score range: 2-10 with higher score indicating a worse outcome. (NCT02163434)
Timeframe: 1 week

Baseline Adjusted Mean Daily Oral Nutrition Score for Days 5-7

Intervention	units on a scale (Mean)
Gabapentin	2.01
Metoclopramide	3.69

Score range: 0-15 with higher score indicating a better outcome. (NCT02163434)
Timeframe: 1 week

Desire to Continue Therapy at Study Endpoint

Intervention	units on a scale (Mean)
Gabapentin	7.86
Metoclopramide	4.01

Scores: 0=no, 1=yes. Thus, a higher score indicates a better outcome. (NCT02163434)
Timeframe: 1 week

Global Satisfaction of Treatment at the Study Endpoint.

Intervention	units on a scale (Mean)
Gabapentin	0.67
Metoclopramide	0.14

Score range: 0-4 with higher score indicating a better outcome. (NCT02163434)
Timeframe: 1 week

Article	Year
The new antiepileptic drugs. Archives of disease in childhood, 1996, Volume: 75, Issue:3 Topics: Abnormalities, Drug-Induced; Acetates; Adolescent; Adult; Amines; Anticonvulsants; Child; Child, Pre	1996
Special considerations: use of lithium in children, adolescents, and elderly populations. The Journal of clinical psychiatry, 1998, Volume: 59 Suppl 6 Topics: Abnormalities, Drug-Induced; Acetates; Adolescent; Adult; Age Factors; Aged; Amines; Anticonvulsants	1998
Effects of antimanic mood-stabilizing drugs on fetuses, neonates, and nursing infants. Southern medical journal, 2001, Volume: 94, Issue:3 Topics: Abnormalities, Drug-Induced; Acetates; Adult; Amines; Antimanic Agents; Benzodiazepines; Breast Feed	2001

Article	Year
Gabapentin in pregnancy and the risk of adverse neonatal and maternal outcomes: A population-based cohort study nested in the US Medicaid Analytic eXtract dataset. PLoS medicine, 2020, Volume: 17, Issue:9 Topics: Abnormalities, Drug-Induced; Adult; Cohort Studies; Female; Gabapentin; Humans; Infant, Small for Ge	2020
The neurotoxic effects of prenatal gabapentin and oxcarbazepine exposure on newborn rats. The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians, 2019, Volume: 32, Issue:3 Topics: Abnormalities, Drug-Induced; Animals; Animals, Newborn; Brain; Dopaminergic Neurons; Female; Gabapen	2019
Genotoxic evaluation of antiepileptic drugs by Drosophila somatic mutation and recombination test. Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association, 2010, Volume: 48, Issue:10 Topics: Abnormalities, Drug-Induced; Amines; Animals; Anticonvulsants; Cyclohexanecarboxylic Acids; Drosophi	2010
Newer anticonvulsants: lamotrigine, topiramate and gabapentin. Birth defects research. Part A, Clinical and molecular teratology, 2012, Volume: 94, Issue:8 Topics: Abnormalities, Drug-Induced; Adult; Amines; Anticonvulsants; Case-Control Studies; Child; Child, Pre	2012
Antiepileptic drugs (AEDs) during pregnancy and risk of congenital jaw and oral malformation. Oral diseases, 2013, Volume: 19, Issue:7 Topics: Abnormalities, Drug-Induced; Adverse Drug Reaction Reporting Systems; Amines; Anticonvulsants; Cyclo	2013
Teratogenic effects of the anticonvulsant gabapentin in mice. Singapore medical journal, 2008, Volume: 49, Issue:1 Topics: Abnormalities, Drug-Induced; Amines; Animals; Anticonvulsants; Body Weight; Congenital Abnormalities	2008
Valproate and other anticonvulsants for psychiatric disorders. The Medical letter on drugs and therapeutics, 2000, Dec-11, Volume: 42, Issue:1094 Topics: Abnormalities, Drug-Induced; Acetates; Adult; Amines; Anti-Anxiety Agents; Anticonvulsants; Bipolar	2000
Pregnancy registries in epilepsy. Epilepsia, 2001, Volume: 42, Issue:11 Topics: Abnormalities, Drug-Induced; Acetates; Amines; Anticonvulsants; Australia; Cross-Cultural Comparison	2001

gabapentin and Abnormalities, Drug-Induced