Venlafaxine

Exposed non-exposed, cohort studies

Study Country
Study period
Study design		 Data source Exposure definition Non-exposure definition Exposition period Sample size
(exposed/unexposed) Or (case / control)		 Remarks Risk of bias
Bérard a
2017 		Canada
1998 - 2010
population based cohort propective 		A register-based cohort study using data from the Quebec Pregnancy Cohort (QPC). Women that had filled at least one prescription for Venlafaxine during the time window of interest (between week 21 and date of birth). (This is a subgroup of exposure among the whole exposed group considered in the study). unexposed (general population or NOS)
Women that did not have filled prescription for antidepressant during the time window of of interest (between week 21 and date of birth). 		2nd and/or 3rd trimester 419 / 141097 SNRI (venlafaxine). Duloxetine and desvenlafaxine were not included in the SNRI category as they were not on the list of medications reimbursed in Quebec during the calendar years of the study;
The Quebec Public Prescription Drug Insurance database (drug name, start date, dosage, duration).
Bérard b (Controls exposed to TCA)
2017 		Canada
1998 - 2009
retrospective cohort (claims database) 		A register-based cohort study using data from the Quebec Pregnancy Cohort (QPC). Depressed/anxious pregnancies with prescription fillings for Venlafaxine (the only one Serotonin–norepinephrine reuptake inhibitor (SNRI) prescribed) dispensed during the first trimester of gestation. (This is a subgroup of exposure among the whole exposed group considered in the study). exposed to other treatment, sick
Depressed/anxious pregnancies with prescription fillings for Tricyclic antidepressants (TCA) dispensed during the first trimester of gestation. 		1st trimester 738 / 382 Overlapping: results of Ramos 2008 (1998-2002) are included in this larger study.
Prescription fillings dispensed to women identified in the cohort from the Quebec public prescription drug insurance database
Bérard b (Controls unexposed, sick)
2017 		Canada
1998 - 2009
retrospective cohort (claims database) 		A register-based cohort study using data from the Quebec Pregnancy Cohort (QPC). Depressed/anxious pregnancies with prescription fillings for Venlafaxine (the only one Serotonin–norepinephrine reuptake inhibitor (SNRI) prescribed) dispensed during the first trimester of gestation. (This is a subgroup of exposure among the whole exposed group considered in the study). unexposed, sick
Pregnancies with a diagnosis or were treated with antidepressants in the year before their pregnancy but with no exposure to antidepressants during the first trimester of gestation. 		1st trimester 738 / 14847 Overlapping: results of Ramos 2008 (1998-2002) are included in this larger study.
Prescription fillings dispensed to women identified in the cohort from the Quebec public prescription drug insurance database
Calderon-Margalit
2009 		USA
1996 - nr
prospective cohort 		The ongoing Omega Study, a prospective cohort study of pregnant mothers who attended prenatal care clinics affiliated with Swedish Medical Center (Seattle, Washington) and Tacoma General Hospital (Tacoma, Washington). Pregnant women who used Venlafaxine during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). unexposed (general population or NOS)
Pregnant women who did not use psychotropic medications during pregnancy. 		during pregnancy (anytime or not specified) 9 / 2493 Of the women who were taking psychotropic medications, 235 (78%) took only one medication, 51 (17%) used two medications, and 14 (5%) used three or more medications.
Participants were interviewed during a prenatal visit prior to 20 weeks of gestation by trained research personnel using a structured questionnaire. Data on medications used during pregnancy were retrieved from both questionnaires and medical records.
Chan (Controls exposed to TCA)
2024 		China
2003 - 2018
retrospective cohort (claims database) 		The Clinical Data Analysis and Reporting System (CDARS), an electronic health-record database developed by the Hospital-Authority which is a statutory body delivering government-subsidized, universal health coverage to all Hong Kong residents. Infants of women with prescription of Venlafaxine only filled during the first trimester and prescriptions filled before pregnancy but with duration overlapping the first trimester. exposed to other treatment, sick
Infants of women with prescription of Tricyclic antidepressants (TCA) only filled during the first trimester and prescriptions filled before pregnancy but with duration overlapping the first trimester. 		1st trimester 47 / 322
Study data were obtained from the Clinical Data Analysis and Reporting System, a database that contains prescribing/dispensing records.
Chan (Controls unexposed, general pop)
2024 		China
2003 - 2018
retrospective cohort (claims database) 		The Clinical Data Analysis and Reporting System (CDARS), an electronic health-record database developed by the Hospital-Authority which is a statutory body delivering government-subsidized, universal health coverage to all Hong Kong residents. Infants of women with prescription of Venlafaxine only filled during the first trimester and prescriptions filled before pregnancy but with duration overlapping the first trimester. unexposed (general population or NOS)
Infants of pregnant women who were not prescribed with any antidepressant within 90 days before the last menstrual period and during the first trimester. 		1st trimester 47 / 462377
Study data were obtained from the Clinical Data Analysis and Reporting System, a database that contains prescribing/dispensing records.
Einarson
2009 		Canada
Not specified.
prospective cohort 		The Motherisk Program, a teratogenic information service. Pregnant women who were exposed to Venlafaxine in the first trimester of pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). unexposed (general population or NOS)
Pregnant women who were not exposed to antidepressants and who had called Motherisk for information regarding nonteratogenic drugs. 		1st trimester 154 / 928
During the initial telephone contact, details of exposure and concurrent exposures are recorded on a standardized questionnaire.
Einarson
2001 		Italy, UK, USA, Brazil and Canada
Not specfied.
prospective cohort 		The Motherisk Program and the other participating Teratology information services. Pregnant women exposed to Venlafaxine at least during organogenesis (4h and 14th week of gestation). unexposed (general population or NOS)
Pregnant women who were given nonteratogenic drugs (loperamide, echinacea, sumatriptan, and dextromethorphan). 		at least 1st trimester 150 / 150 Overlapping: malformations not reported because probable overlapping with Einarson 2009 (2 same malformations reported). 'The majority of the women in the venlafaxine group (70% [N=105]) took 75 mg/day of venlafaxine'
On successful contact, information on each woman’s exposure history and pregnancy outcome were obtained, along with other measures of interest, with the aid of a structured questionnaire.
Furu
2015 		Denmark, Finland, Iceland, Norway, and Sweden
1996 - 2010
population based cohort retrospective 		Nordic population (Denmark, Finland, Iceland, Norway, and Sweden) identified from nationwide health registers. Infants born to women who filled a prescription for Venlafaxine from 30 days before the first day of the last menstrual period until the end of the first trimester (defined as 97 days after the last menstrual period). unexposed (general population or NOS)
Infants not exposed to any antidepressant (ATC code N06A) in utero. 		1st trimester 2763 / 2266875
The Nordic prescription registers include data on dispensed drugs, substance, brand name, and formulation, together with date of dispensing.
Hanley
2016 		Canada
2002 - 2011
retrospective cohort (claims database) 		A population-based cohort study in British Columbia, Canada. A supply of Venlafaxine during pregnancy (late- or mid-pregnancy exposure). (This is a subgroup of exposure among the whole exposed group considered). unexposed (general population or NOS)
No supply of any antidepressants in the 5 months before delivery (during mid- to late pregnancy). 		2nd trimester, late pregnancy 1390 / 310813 Venlafaxine more than 98% of SNRI. 'We excluded all women using 'other antidepressants' (such as amitriptyline, bupropion, and trazodone) from our final analyses. Women using combination SSRI and SNRI therapy were also excluded.'
The British Columbia PharmaNet (a prescription dispensation database into which all prescriptions dispensed must be entered by law).
Heuvelman
2023 		United Kingdom
1995 - 2017
retrospective cohort (claims database) 		The UK Clinical Practice Research Datalink, a large, ongoing database of anonymised primary care medical records for patients registered with a general practice in the United Kingdom. Women who had initiated or continued Lofepramine for the treatment of depressive symptoms during pregnancy. unexposed, sick
Women who did not initiate or who discontinue antidepressants during pregnancy. 		during pregnancy (anytime or not specified) 818 / 16330 Dose–response relationships, sibling design (consistant results) and negative control for antidepressants use as a whole (not for the class of antidepressants).
The Clinical Practice Research Datalink (CPRD) contains an extensive code list to identify the name, formulation and dose of medications, which are mandatory fields in the prescription electronic record (according to protocol).
Kjaersgaard (Controls unexposed, NOS)
2013 		Denmark
1997 - 2008
population based cohort retrospective 		Danish administrative health registries. Mother that had redeemed a prescription for Venlafaxine at any time from 30 days before conception up to 1 day before the end of pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). unexposed (general population or NOS)
Mother that had not redeemed any prescription for antidepressant medication from 6 months before conception up to 1 day before the end of the pregnancy. 		during pregnancy (anytime or not specified) -9 / 983258 Molar or ectopic pregnancies (ICD-10: O00.0– O01.9) were excluded from the main analyses. Unexposed cohort: 1843 plus 981415 = 983258.
Information on all redeemed prescriptions was obtained from the Denmark Registry of Medicinal Product Statistics.
Kjaersgaard (Controls unexposed, sick)
2013 		Denmark
1997 - 2008
population based cohort retrospective 		Danish administrative health registries. Mother with a registry-based diagnosis of depressive disorder that had redeemed a prescription for Venlafaxine at any time from 30 days before conception up to 1 day before the end of pregnancy. unexposed, sick
Mother with a registry-based diagnosis of depressive disorder that had not redeemed any prescription for antidepressant medication from 6 months before conception up to 1 day before the end of the pregnancy. 		during pregnancy (anytime or not specified) -9 / -9 Molar or ectopic pregnancies (ICD-10: O00.0– O01.9) were excluded from the main analyses.
Information on all redeemed prescriptions was obtained from the Denmark Registry of Medicinal Product Statistics.
Kolding (Controls unexposed, disease free)
2021 		Denmark
2007 - 2014
population based cohort retrospective 		Five nationwide registries and databases: the Danish Fetal Medicine Database, the Danish National Patient Registry, the Danish Medical Birth Registry and the Danish Health Services Prescription Database. Pregnant women with two or more redeemed prescriptions of Venlafaxine from 28 days before through 70 days after the conception date. (This is a subgroup of exposure among the whole exposed group considered in the study). unexposed, disease free
Pregnant women with absence of redemptions for an antidepressant in the same time window, combined with absence of former use. 		1st trimester 847 / 353581 'Pregnancies with fetal chromosomal abnormalities were excluded regardless of presence of other malformations.'
Exposure to antidepressants was measured using redeemed prescriptions through linkage to the Danish Health Services Prescription Database.
Kolding (Controls unexposed, sick)
2021 		Denmark
2007 - 2014
population based cohort retrospective 		Five nationwide registries and databases: the Danish Fetal Medicine Database, the Danish National Patient Registry, the Danish Medical Birth Registry and the Danish Health Services Prescription Database. Pregnant women with two or more redeemed prescriptions of Venlafaxine from 28 days before through 70 days after the conception date. (This is a subgroup of exposure among the whole exposed group considered in the study). unexposed, sick
Pregnant women with untreated- or well treated depression or anxiety without antidepressant use in the pregnancy (one or more redeemed prescription of an antidepressant from 365 to 183 days preconception and no redemptions between 182 days preconception through the first trimester). 		1st trimester 847 / 6326 'Pregnancies with fetal chromosomal abnormalities were excluded regardless of presence of other malformations.'
Exposure to antidepressants was measured using redeemed prescriptions through linkage to the Danish Health Services Prescription Database.
Marks (Controls exposed to Bupropion)
2021 		USA
2010 - 2019
retrospective cohort 		Electronic medical records (EMRs) through the Regenstrief Institute in Indianapolis, USA. Pregnant women with one (or more) prescription of Venlafaxine written during the time period studied. (This is a subgroup of exposure among the whole exposed group considered in the study). exposed to other treatment, sick
Pregnant women with one (or more) prescription of Bupropion written during the time period studied. 		during pregnancy (anytime or not specified) 132 / 406 '252 women (6.8%) prescribed >1 antidepressant'=> considered as monotherapy.
Data were obtained from electronic medical records (EMRs) through the Regenstrief Institute in Indianapolis.
Marks (Controls unexposed, sick)
2021 		USA
2010 - 2019
retrospective cohort 		Electronic medical records (EMRs) through the Regenstrief Institute in Indianapolis, USA. Pregnant women with one (or more) prescription of Venlafaxine during the third trimester exposure. (This is a subgroup of exposure among the whole exposed group considered in the study). unexposed, sick
Pregnant women who took an antidepressant at some point during pregnancy but did not have a prescription for any antidepressant during the relevant period of exposure. 		3rd trimester 57 / -9 '252 women (6.8%) prescribed >1 antidepressant'=> considered as monotherapy. 'Neonatal intensive care unit admission" => not considered here because an exposure in early pregnancy could also lead to NICU admission.
Data were obtained from electronic medical records (EMRs) through the Regenstrief Institute in Indianapolis.
Martin
2024 		Norway, Sweden and United Kingdom.
1996 - 2020
population based cohort retrospective 		The UK’s Clinical Practice Research Datalink (CPRD), the Norway’s Medical Birth Registry and the Sweden’s Medical Birth Register. Singleton deliveries with maternal Venlafaxine (without concurrent prescriptions for different antidepressants) use during pregnancy proxied by prescriptions in the United Kingdom and dispensations in Norway and Sweden. unexposed (general population or NOS)
Singleton deliveries without maternal antidepressants use during pregnancy proxied by prescriptions in the United Kingdom and dispensations in Norway and Sweden. 		during pregnancy (anytime or not specified) 6441 / 2408707 A group ‘multiple’ (i.e drug switching or concurrent prescriptions for different antidepressants) is available => thus individual antidepressant considered as monotherapy. Unexposed numbers: Table S4.
In the UK, prescription data were based on the prescriptions written by general practitioners (CPRD GOLD), whereas in Norway and Sweden, dispensation of prescription drugs from all ambulatory pharmacies was used (Norwegian Prescription Database, and Swedish Prescribed Drug Register).
Nulman (Controls unexposed, disease free)
2012 		Canada
2001 - 2006
prospective cohort 		The Motherisk program at the Hospital for Sick Children in Toronto. Depressed women who took Venlafaxine during pregnancy. unexposed, disease free
Nondepressed, healthy pregnant women who called Motherisk to inquire about nonteratogenic exposure (e.g., acetaminophen). 		during pregnancy (anytime or not specified) 62 / 62 'Excluded were mothers exposed to polytherapy for depression or known teratogens, mothers with substance abuse, mothers with other psychiatric conditions, prematurity, mothers and/or children with medical conditions that may affect cognitive outcomes.'
At the time of the first contact with Motherisk during pregnancy, information about medications was collected.
Nulman (Controls unexposed, sick)
2012 		Canada
2001 - 2006
prospective cohort 		The Motherisk program at the Hospital for Sick Children in Toronto. Depressed women who took Venlafaxine during pregnancy. unexposed, sick
Depressed women who were untreated during pregnancy (discontinued pharmacotherapy before conception). 		during pregnancy (anytime or not specified) 62 / 54 'Excluded were mothers exposed to polytherapy for depression or known teratogens, mothers with substance abuse, mothers with other psychiatric conditions, prematurity, mothers and/or children with medical conditions that may affect cognitive outcomes.'
At the time of the first contact with Motherisk during pregnancy, information about medications was collected.
Oberlander
2008 		Canada
1997 - 2002
retrospective cohort (claims database) 		Population-based health-care utilization databases from the province of British Columbia. Infants exposed to Venlafaxine in the first trimester of pregnancy. unexposed (general population or NOS)
Infants with no exposure to either of these drugs (Serotonin Reuptake Inhibitors (SRI) or benzodiazepine) in the first trimester of pregnancy. 		1st trimester 250 / 107320
PharmaNet, a province-wide network recording all prescriptions dispensed by British Columbian pharmacists outside hospitals.
Ozturk
2016 		Turkey
2007 - 2012
prospective cohort 		An observational cohort study based on a prenatal consultation service. Pregnant women exposed to Venlafaxine during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). unexposed (general population or NOS)
Pregnant women selected from the non-teratogen exposed pregnancies in the same year. 		at least 1st trimester 13 / 275 'Drug exposures took place in 81% during the first trimester, and 11% in all three trimesters. Medical treatments were discontinued in most of recognized pregnancies.'=> considered as 'At least first trimester'.
At the first contact, initiated via gynecologists, a detailed patient history form was used to notably record all drug exposures (dose, duration and timing in pregnancy).
Palmsten (Controls exposed to TCA)
2013 		USA
2000 - 2007
retrospective cohort (claims database) 		The US nationwide Medicaid Analytic eXtract (MAX). Pregnant women with a depression diagnosis and a dispensation of Venlafaxine in monotherapy during the exposure window. exposed to other treatment, sick
Pregnant women with a depression diagnosis and a dispensation of tricyclic antidepressant in monotherapy during the exposure window. 		2nd and/or 3rd trimester 1113 / 441 Women who received only one antidepressant class during the window were classified as having either SSRI, SNRI, tricyclic, bupropion or other antidepressant (mirtazapine, nefazodone, trazodone) monotherapy.
Outpatient pharmacy-dispensing data.
Palmsten (Controls unexposed, sick)
2013 		USA
2000 - 2007
retrospective cohort (claims database) 		The US nationwide Medicaid Analytic eXtract (MAX). Pregnant women with a depression diagnosis and a dispensation of Venlafaxine in monotherapy during the exposure window. unexposed, sick
Pregnant women with a depression diagnosis and no antidepressant exposure between the LMP and the end of the window. 		2nd and/or 3rd trimester 1113 / 59219 Women who received only one antidepressant class during the window were classified as having either SSRI, SNRI, tricyclic, bupropion or other antidepressant (mirtazapine, nefazodone, trazodone) monotherapy.
Outpatient pharmacy-dispensing data.
Palmsten b
2013 		USA
2000 - 2007
retrospective cohort (claims database) 		The Medicaid Analytic eXtract (MAX) data Women with a supply of Venlafaxine monotherapy that overlapped with the delivery date. (This is a subgroup of exposure among the whole exposed group considered in the study). unexposed, sick
Women who had no supply of antidepressants in the five months before delivery. 		late pregnancy 763 / 69044 Exclusion of women who were exposed to both drugs types (polytherapy) during the five months before delivery.
Data of prescription.
Rai (Controls exposed to TCA)
2017 		Sweden
2001 - 2011
prospective cohort 		The Stockholm youth cohort, an observational prospective cohort study of Stockholm County. Children of mothers who used Venlafaxine during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). exposed to other treatment, sick
Children of mothers who used Clomipramine during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). 		during pregnancy (anytime or not specified) 213 / 235 Overlapping: Rai 2017 is an update of Rai 2013. About 3% with co-exposure to SSRI and Non-SSRI antidepressants (91/3342) => considered as SSRI monotherapy and Non-SSRI monotherapy.
Information on maternal use of antidepressants in pregnancy is derived from the medical birth register (as reported by pregnant women at their antenatal interview, at a median of 10 weeks’ gestation) and supplemented it with the prescribed drug register (available from July 2005).
Rai (Controls unexposed, disease free)
2017 		Sweden
2001 - 2011
prospective cohort 		The Stockholm youth cohort, an observational prospective cohort study of Stockholm County. Children of mothers who used Venlafaxine during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). unexposed, disease free
No maternal psychiatric disorder and unexposed to antidepressants 		during pregnancy (anytime or not specified) 213 / 238943 Overlapping: Rai 2017 is an update of Rai 2013. About 3% with co-exposure to SSRI and Non-SSRI antidepressants (91/3342) => considered as SSRI monotherapy and Non-SSRI monotherapy.
Information on maternal use of antidepressants in pregnancy is derived from the medical birth register (as reported by pregnant women at their antenatal interview, at a median of 10 weeks’ gestation) and supplemented it with the prescribed drug register (available from July 2005).
Rai (Controls unexposed, sick)
2017 		Sweden
2001 - 2011
prospective cohort 		The Stockholm youth cohort, an observational prospective cohort study of Stockholm County. Children of mothers who used Venlafaxine during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). unexposed, sick
Children of mothers with psychiatric disorders (any time before the birth of the child) who did not take antidepressants during pregnancy. 		during pregnancy (anytime or not specified) 213 / 12325 Overlapping: Rai 2017 is an update of Rai 2013. About 3% with co-exposure to SSRI and Non-SSRI antidepressants (91/3342) => considered as SSRI monotherapy and Non-SSRI monotherapy.
Information on maternal use of antidepressants in pregnancy is derived from the medical birth register (as reported by pregnant women at their antenatal interview, at a median of 10 weeks’ gestation) and supplemented it with the prescribed drug register (available from July 2005).
Rampono
2009 		Australia
Not specified.
prospective cohort 		The outpatient clinics of the Department of Psychological Medicine at King Edward Memorial Hospital, Western Australia. Pregnant patients treated with serotonin norepinephrine reuptake inhibitor (SNRI) antidepressants (venlafaxine only) during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). unexposed, sick
Pregnant women untreated with antidepressants during pregnancy. 		during pregnancy (anytime or not specified) 11 / 18 Maternal antenatal EPDS scores were not different between cases and controls. Mothers who were known substance abusers, or who took any medication known to alter infant behaviour (apart from those being investigated) were excluded from the study.
The antidepressant and dose for each individual patient was determined by the prescriber (JR) according to the patients needs. The analyses of medicines and metabolites in maternal and infant plasma were carried out by high performance liquid chromatography.
Richardson
2019 		The United Kingdom.
1995 - 2018
prospective cohort 		The United Kingdom Teratology Information Service (UKTIS). Pregnancies in which mothers had used venlafaxine at any stage of pregnancy. unexposed (general population or NOS)
Pregnancies unexposed to any antidepressant medications (matching ratio 5:1). 		1st trimester, at least 1st trimester, during pregnancy (anytime or not specified) 281 / 1405 Gestational venlafaxine exposure occurred in at least the first trimester for the majority of the venlafaxine exposed study group (n = 270/281, 96.1%). Concomitant psychiatric medication use was common among the venlafaxine exposed pregnancies.
Upon contact with the service, relevant information is collected from the health professional to allow accurate fetal risk assessment. Subsequently, all enquiries which involve maternal exposures in pregnancy are included in the prospective surveillance system.
Te Winkel
2016 		Finland, France, Israel, Italy, Netherlands and Switzerland.
Not specified.
prospective cohort 		Nine centers of the European Network of Teratology Information Services (ENTIS). Pregnant women exposed to Venlafaxine during pregnancy. unexposed (general population or NOS)
Pregnant women not exposed to any known teratogen during pregnancy. 		1st trimester, during pregnancy (anytime or not specified) 732 / 724 Number of pregnancies in the control group: 656 live births - 6 twins plus 46 spontaneous abortions plus 25 ETOPs plus 3 stillbirths.
Information about the exposure was collected after individual risk counseling. Standardized procedures for data collection and follow up were used by each center.
Yaris
2005 		Turkey
1999 - 2004
prospective cohort 		Toxicology Information and Follow-up Service Women who were exposed to Venlafaxine during pregnancy for depression, anxiety, and psychotic disorders. (This is a subgroup of exposure among the whole exposed group considered in the study). unexposed (general population or NOS)
Women who did not use any drug while pregnant. 		during pregnancy (anytime or not specified) 11 / 248 Raw data for Intrauterine exitus not reported because the nb of cases in the unexposed group not clearly stated. Raw data for premature delivery not reported because the denominator is not clearly stated.
Data surveyed by the interviews.

Case-control studies

Study Country
Study period
Study design		 Data source Case Control Exposition Exposition period Sample size
(exposed/unexposed) Or (case / control)		 Remarks Risk of bias
Anderson
2020 		USA
1997 - 2011
case control 		The National Birth Defects Prevention Study (NBDPS), a US population-based, multisite case-control study. The case infants were infants born alive or died at 20 SG or more and who had received a diagnosis of at least one selected birth defect. The controls were live-born infants with no major birth defects who were randomly selected from hospital or state birth-certificate records from the same geographic areas. Information on exposure to SSRIs and other potential risk factors during pregnancy were collected by standardized telephone interviews with mothers of case and control infants, conducted 6 weeks to 24 months after the EDD. 1st trimester 30630 / 11478 Overlapping: this study included data obtained by Werler 2018 (gastroschisis), Lind 2013 (hypospadias) and Polen 2013 (individual malformations). 'Infants with chromosomal abnormalities or single-gene conditions were excluded.'
Case infants were ascertained through population-based birth-defects surveillance systems in 10 U.S. states. Controls were selected randomly from the same geographic areas. Clinical data were abstracted from medical records and classified by clinician geneticists and other clinicians.
Dandjinou
2019 		Canada
1998 - 2015
nested case control 		The Quebec Pregnancy Cohort (QPC), a Canadian provincial database. Pregnant women with a diagnosis of gestational diabetes mellitus (GDM) identified using diagnosis codes ICD-9: 250.0–250.9, 648.0, 648.8, 790.2, 775.1 or ICD-10: E10–E14, O24, R73.0) or at least one filled prescription for an antidiabetic drug allowed during pregnancy (insulin, glyburide or metformin), both after week 20 of gestation, whichever occurred first. Pregnant women that did not have a diagnosis of gestational diabetes mellitus (GDM) at the index date. The Quebec Prescription Drug Insurance Database (drug name, start date, dosage and duration). during pregnancy (anytime or not specified) 20905 / 209050 The 10 categories of exposure were mutually exclusive.
The medical service database (RAMQ: diagnoses and medical procedures), the Hospitalisation Archive Database (MedEcho: in-hospital diagnoses and procedures) and the Quebec Statistics Database (Institut de la statistique du Québec (ISQ):patient sociodemographic information).
Kieler
2015 		Denmark, Finland, and Norway
1996 - 2007
nested case control 		National registers of Denmark, Finland, and Norway. Women with elective termination of pregnancy at 12–23 weeks of gestation. Women that continued their pregnancy, randomly selected and matched with cases on key factors. The prescription registers include data on dispensed item, substance, brand name, and formulation, together with date of dispensing for over 95% of the total outpatient population. 3 months (or more) before pregnancy or during pregnancy, during pregnancy (anytime or not specified) 14902 / 148929 The (ORs) are presented for women exposed to only one type of antidepressant during the exposure period.
In the registers the diagnoses and pregnancy complications are classified according to the national version of the International Classification of Diseases (ICD).
Laspro
2024 		USA
2013 - 2023
nested case control 		EPIC Cosmos, a database incorporating health information of 180 million patients, throughout the United States from approximately 180 US institutions utilizing EPIC medical records. Newborns with oral clefts (ICD 10 codes Q35 or Q36 or Q37). Newborns without oral clefts. Gestational medication use was identified by medications, prescribed, provider-administered, or reported use by mothers at any point during pregnancy. during pregnancy (anytime or not specified) 12098 / -9 P-values were calculated, while to account for multiple testing (693 hypotheses) Benjamini- Hochberg (BH) corrections were performed with a false discovery rate (Q) of 0.05.
Oral cleft cohorts were isolated using a combination of ICD codes, from the EPIC medical records.
Nakhai-Pour
2010 		Canada
1998 - 2003
nested case control 		The Quebec Pregnancy Registry, built with the linkage of three administrative databases: the Régie de l’assurance maladie du Québec (RAMQ), the Med-Echo database and the Institut de la statistique du Québec database. Pregnant women with a diagnosis or a procedure for spontaneous abortion between the first day and the 20th week of gestation. Randomly selected pregnant women who did not have a spontaneous abortion at or before the same gestational age as their matched case did. The Régie de l’assurance maladie du Québec (RAMQ) database which provides prospectively collected data on filled prescriptions. during pregnancy (anytime or not specified) 5124 / 51240
The Régie de l’assurance maladie du Québec (RAMQ) (physician-based diagnoses according to the ICD-9), the Med-Echo database (data on acute care hospital admissions) and the Institut de la statistique du Québec database (data on all births and deaths in Quebec).

Risk of bias: : NA;   : low;   : moderate;   : serious;   : critical;   : unclear;  

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