| 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 |
|---|---|---|---|---|---|---|---|---|
|
Ankarfeldt (Controls unexposed, NOS) 2023 |
Sweden and Denmark 2004 - 2016 population based cohort retrospective |
A nationwide observational cohort study, based on Danish and Swedish national registers, | Pregnant women with at least one redeemed prescription of duloxetine (ATC: N06AX21) from a community pharmacy during pregnancy (early exposure and/or late exposure) (and no SSRI or venlafaxine comedication). |
unexposed (general population or NOS)
Pregnant women with not exposed to duloxetine during pregnancy and from 90 days prior to last menstrual period. |
early pregnancy, late pregnancy | 1589 / 2080880 | 1589 and 450 were duloxetine exposed in early and late pregnancies, respectively. Few overlapping between Reis 2010 (1995 - 2007) and Ankarfeldt 2023 (2004 - 2016) => the 2 studies were kept. | |
| Information about redeemed prescriptions obtained from the national prescription registers. | ||||||||
|
Ankarfeldt (Controls unexposed, sick) 2023 |
Sweden and Denmark 2004 - 2016 population based cohort retrospective |
A nationwide observational cohort study, based on Danish and Swedish national registers, | Pregnant women with at least one redeemed prescription of duloxetine (ATC: N06AX21) from a community pharmacy during pregnancy (early exposure and/or late exposure) (and no SSRI or venlafaxine comedication). |
unexposed, sick
Pregnant women who have discontinued duloxetine, i.e with at least one redeemed prescription of duloxetine between 365 days prior to LMP, but not during the exposure-time window. |
early pregnancy, late pregnancy | 1589 / 2839 | 1589 and 450 were duloxetine exposed in early and late pregnancies, respectively. Few overlapping between Reis 2010 (1995 - 2007) and Ankarfeldt 2023 (2004 - 2016) => the 2 studies were kept. | |
| Information about redeemed prescriptions obtained from the national prescription registers. | ||||||||
|
Ankarfeldt a (Controls unexposed, NOS) 2021 |
Sweden and Denmark 2004 - 2016 population based cohort retrospective |
Nationwide registers from Sweden and Denmark covering all pregnancies. | At least one redeemed prescription of duloxetine from Last menstrual period (LMP) to 90 days after LMP for malformations or to the end of pregnancy (for stillbirth). |
unexposed (general population or NOS)
No redeemed prescription of duloxetine in the exposure time window (women with duloxetine exposure from 90 days prior to LMP but no exposure from LMP to 90 days after LMP were excluded). |
1st trimester, during pregnancy (anytime or not specified) | 1512 / 2074652 | Cohort for stillbirths: 1668 exposed; 2130495 unexposed.For malformations: exclusion mothers with a redeemed prescription for a teratogenic drug in the period from LMP to 90 days post LMP. | |
| The prescription registers containing electronically submitted information on prescriptions dispensed by pharmacies, classified according to the global ATC system. | ||||||||
|
Ankarfeldt a (Controls unexposed, sick) 2021 |
Sweden and Denmark 2004 - 2016 population based cohort retrospective |
Nationwide registers from Sweden and Denmark covering all pregnancies. | At least one redeemed prescription of duloxetine from Last menstrual period (LMP) to 90 days after LMP for malformations or to the end of pregnancy (for stillbirth). |
unexposed, sick
Duloxetine discontinuers: at least one redeemed prescription of duloxetine between 365 days prior to LMP to LMP and not during pregnancy. |
1st trimester, during pregnancy (anytime or not specified) | 1512 / 2876 | Cohort for stillbirths: 1668 exposed; 2815 discontinuers.For malformations: exclusion mothers with a redeemed prescription for a teratogenic drug in the period from LMP to 90 days post LMP. | |
| The prescription registers containing electronically submitted information on prescriptions dispensed by pharmacies, classified according to the global ATC system. | ||||||||
|
Ankarfeldt b (Controls unexposed, sick) 2021 |
Denmark 2004 - 2016 population based cohort retrospective |
The Danish National Prescription Register, the Danish National Patient Register, the Medical Birth Register, and registers containing information on education and household income. | At least one redeemed prescription of duloxetine from 30 days prior to last menstrual period (LMP) to 140 days post LMP, or the end of the pregnancy, whichever came first. |
unexposed, sick
Duloxetine discontinuers: at least one redeemed prescription of duloxetine between 365 days prior to LMP to 30 days prior to LMP, but no redeemed prescription of duloxetine in the exposure time window. |
during pregnancy (anytime or not specified) | 1212 / 1418 | Overlapping: partial overlapping between Ankarfeldt 2021b (2004 - 2016) and Kjaersgaard 2013 (1997 - 2008). Because the 2 study periods are longer than the common period, the 2 studies were kept. | |
| Information on maternal exposure to antidepressant drugs was based on redeemed prescriptions from community pharmacies using the Danish National Prescription Register. | ||||||||
|
Ankarfeldt b Controls unexposed, NOS) 2021 |
Denmark 2004 - 2016 population based cohort retrospective |
The Danish National Prescription Register, the Danish National Patient Register, the Medical Birth Register, and registers containing information on education and household income. | At least one redeemed prescription of duloxetine from 30 days prior to last menstrual period (LMP) to 140 days post LMP, or the end of the pregnancy, whichever came first. |
unexposed (general population or NOS)
Duloxetine non-exposed: no redeemed prescriptions of duloxetine in the exposure time window; |
during pregnancy (anytime or not specified) | 1212 / 1018745 | Overlapping: partial overlapping between Ankarfeldt 2021b (2004 - 2016) and Kjaersgaard 2013 (1997 - 2008). Because the 2 study periods are longer than the common period, the 2 studies were kept. | |
| Information on maternal exposure to antidepressant drugs was based on redeemed prescriptions from community pharmacies using the Danish National Prescription Register. | ||||||||
|
Bahat 2020 |
Israel 2001 - 2015 prospective cohort |
The Israeli Teratology Information Service (TIS). | Pregnant women counseled for duloxetine exposure in the first trimester. |
unexposed (general population or NOS)
Pregnant women counseled for non-teratogenic exposure in pregnancy. |
1st trimester | 128 / 511 | Major congenital anomalies excluding genetic or cytogenetic not reported because number of cases, exposures and exclusions not provided. | |
| Not specified. | ||||||||
|
Huybrechts (Controls unexposed, NOS) 2020 |
USA 2004 - 2013 retrospective cohort (claims database) |
The nationwide Medicaid Analytic eXtract (MAX). | Pregnant women who filled at least one outpatient prescription for duloxetine during the etiologically relevant window. |
unexposed (general population or NOS)
Pregnant women not exposed to duloxetine during the etiologically relevant exposure window. |
1st trimester, early pregnancy, late pregnancy | 2532 / 1284827 | Exclusion of pregnancies exposed to a known teratogenic drug (warfarin, antineoplastic agents, lithium, isotretinoin, misoprostol, thalidomide) 1st trimester. Partial overlapping for preeclampsia and cardiac malfo (Palmsten 2013, Huybrechts 2014 and 2020) | |
| The Medicaid Analytic eXtract (MAX) dataset that contains all filled outpatient drug prescriptions for Medicaid beneficiaries. | ||||||||
|
Huybrechts (Controls unexposed, sick) 2020 |
USA 2004 - 2013 retrospective cohort (claims database) |
The nationwide Medicaid Analytic eXtract (MAX). | Pregnant women who filled at least one outpatient prescription for duloxetine during the etiologically relevant window. |
unexposed, sick
Pregnant women exposed to duloxetine before but not during pregnancy (≥1 duloxetine dispensing between 6 months and 60 days before LMP but not during first trimester). |
1st trimester | 2532 / 2456 | Exclusion of pregnancies exposed to a known teratogenic drug (warfarin, antineoplastic agents, lithium, isotretinoin, misoprostol, thalidomide) 1st trimester. Partial overlapping for preeclampsia and cardiac malfo (Palmsten 2013, Huybrechts 2014 and 2020) | |
| The Medicaid Analytic eXtract (MAX) dataset that contains all filled outpatient drug prescriptions for Medicaid beneficiaries. | ||||||||
|
Källen 2013 |
Sweden 1996 - 2011 population based cohort retrospective |
Swedish Medical Birth Register | Infants whose mothers used Duloxetine in early pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed (general population or NOS)
Infants in population whose mothers used at least one of a central nervous system active drugs (less than 3%) or weren't exposed in early pregnancy. |
early pregnancy | 286 / 1575847 | RR calculated with observed/expected numbers. Partial overlapping for major malformations between Kallen 2013 (1996- 2011) and Ankarfeldt 2021a (2004-2016): because the non common study periods are longer than the common period, the 2 studies were kept. | |
| The exposure data are either based on midwife interviews from the first antenatal visit (usually during weeks 10–12) or on linkage with a prescribed drug register. | ||||||||
|
Kjaersgaard (Controls unexposed, NOS) 2013 |
Denmark 1997 - 2008 population based cohort retrospective |
Danish administrative health registries. | Mother that had redeemed a prescription for Duloxetine 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. Partial overlapping between Ankarfeldt 2021b (2004 - 2016) and Kjaersgaard 2013 (1997 - 2008). | |
| 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 Duloxetine 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. Partial overlapping between Ankarfeldt 2021b (2004 - 2016) and Kjaersgaard 2013 (1997 - 2008). | |
| Information on all redeemed prescriptions was obtained from the Denmark Registry of Medicinal Product Statistics. | ||||||||
|
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 Duloxetine 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) | 139 / 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 Duloxetine 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 | 59 / -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 Duloxetine (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) | 1602 / 2408707 | Overlapping: Martin 2024 and Ankarfeld 2023 both studied Preterm and SGA with Swedish databases (and other databases) => these outcomes not reported here (but reported for Norway and UK in separately); but Apgar score (no overlapping) reported here. | |
| 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). | ||||||||
|
Martin - Norway 2024 |
Norway 2009 - 2020 population based cohort retrospective |
The Norway’s Medical Birth Registry, the Norwegian Patient Registry and the Norwegian Prescription Database. | Singleton deliveries with maternal Duloxetine (without concurrent prescriptions for different antidepressants) use during pregnancy proxied by dispensations. |
unexposed (general population or NOS)
Singleton deliveries without maternal antidepressants use during pregnancy proxied by dispensations. |
during pregnancy (anytime or not specified) | 115 / 662309 | Overlapping: Martin 2024 and Ankarfeld 2023 both studied Preterm and SGA with Swedish databases (and other databases) with large common study periods => SE data not reported but Norway and UK reported here separately. | |
| Dispensation of prescription drugs from all ambulatory pharmacies was used from the Norwegian Prescription Database. | ||||||||
|
Martin - UK 2024 |
United Kingdom. 1996 - 2018 population based cohort retrospective |
The United Kingdom’s Clinical Practice Research Datalink (CPRD). | Singleton deliveries with maternal Duloxetine (without concurrent prescriptions for different antidepressants) use during pregnancy proxied by prescriptions. |
unexposed (general population or NOS)
Singleton deliveries without maternal antidepressants use during pregnancy proxied by prescriptions. |
during pregnancy (anytime or not specified) | 71 / 330696 | Unexposed numbers: Table S4. Overlapping: Martin 2024 and Ankarfeld 2023 both studied Preterm and SGA with Swedish databases (and other databases) with large common study periods => SE data not reported but Norway and UK reported here separately. | |
| In the United Kingdom, prescription data were based on the prescriptions written by general practitioners (CPRD GOLD). | ||||||||
|
Ozturk 2016 |
Turkey 2007 - 2012 prospective cohort |
An observational cohort study based on a prenatal consultation service. | Pregnant women exposed to Duloxetine 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 | 3 / 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 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 Duloxetine 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 | -9 / 59219 | Nb of exposures not provided by authors. 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. | ||||||||
| 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 | 'Infants with recognized or strongly suspected chromosomal abnormalities or single-gene conditions were excluded from the study.' | |
| 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. | |||||||||
Risk of bias: : NA; : low; : moderate; : serious; : critical; : unclear;
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