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gabapentin and Abnormalities, Drug-Induced

gabapentin has been researched along with Abnormalities, Drug-Induced in 12 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

ExcerptRelevanceReference
"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."9.17Pregnancy 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."7.96Gabapentin 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."5.17Pregnancy 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."3.96Gabapentin 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)."3.74Teratogenic 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."3.71Pregnancy registries in epilepsy. ( Annegers, JF; Beghi, E, 2001)
" It still remains unclear how much these drugs are safe during pregnancy."1.51The 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)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's2 (16.67)18.2507
2000's4 (33.33)29.6817
2010's5 (41.67)24.3611
2020's1 (8.33)2.80

Authors

AuthorsStudies
Patorno, E1
Hernandez-Diaz, S2
Huybrechts, KF1
Desai, RJ1
Cohen, JM1
Mogun, H1
Bateman, BT1
Erisgin, Z1
Ayas, B1
Nyengaard, JR1
Ercument Beyhun, N1
Terzi, Y1
Fujii, H1
Goel, A1
Bernard, N1
Pistelli, A1
Yates, LM1
Stephens, S1
Han, JY1
Matsui, D1
Etwell, F1
Einarson, TR1
Koren, G1
Einarson, A1
Yüksel, M1
Sarıkaya, R1
Bostanci, N1
Holmes, LB1
Koo, J1
Zavras, A1
Prabhu, LV1
Rai, R1
Pai, MM1
Yadav, SK1
Madhyastha, S1
Goel, RK1
Singh, G1
Nasar, MA1
Appleton, RE1
Tueth, MJ1
Murphy, TK1
Evans, DL1
Iqbal, MM1
Gundlapalli, SP1
Ryan, WG1
Ryals, T1
Passman, TE1
Beghi, E1
Annegers, JF1

Clinical Trials (1)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Comparison of Gabapentin and Metoclopramide for Treating Hyperemesis Gravidarum[NCT02163434]Phase 231 participants (Actual)Interventional2014-06-30Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

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

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

Interventionunits on a scale (Mean)
Gabapentin6.35
Metoclopramide13.22

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

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

Interventionunits on a scale (Mean)
Gabapentin2.01
Metoclopramide3.69

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

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

Interventionunits on a scale (Mean)
Gabapentin7.86
Metoclopramide4.01

Desire to Continue Therapy at Study Endpoint

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

Interventionunits on a scale (Mean)
Gabapentin0.67
Metoclopramide0.14

Global Satisfaction of Treatment at the Study Endpoint.

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

Interventionunits on a scale (Mean)
Gabapentin2.22
Metoclopramide0.63

Percent of Subjects Requiring Repeat iv Hydration or Hospital Admission for HG From the Outpatient Setting.

(NCT02163434)
Timeframe: 1 week

InterventionParticipants (Count of Participants)
Gabapentin5
Metoclopramide5

Reviews

3 reviews available for gabapentin and Abnormalities, Drug-Induced

ArticleYear
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

Trials

1 trial available for gabapentin and Abnormalities, Drug-Induced

ArticleYear
Pregnancy outcomes following gabapentin use: results of a prospective comparative cohort study.
    Neurology, 2013, Apr-23, Volume: 80, Issue:17

    Topics: Abnormalities, Drug-Induced; Adult; Amines; Anticonvulsants; Cyclohexanecarboxylic Acids; Female; Ga

2013

Other Studies

8 other studies available for gabapentin and Abnormalities, Drug-Induced

ArticleYear
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