Fluvoxamine

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
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 Fluvoxamine dispensed during the first trimester of gestation. unexposed, sick
Depressed/anxious pregnancies with no exposure to any antidepressants during the first trimester of gestation. 		1st trimester 55 / 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.
Bérard
2016 		Canada
1998 - 2009
retrospective cohort (claims database) 		The Québec Pregnancy Children Cohort (QPC), a register-based study of an ongoing population-based cohort. Pregnant women having at least 1 prescription of Fluvoxamine filled at any time during the second/third trimester of pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). unexposed (general population or NOS)
Infants who were not exposed in utero to antidepressants at any time throughout gestation. 		2nd and/or 3rd trimester 35 / 142716 Material and methods based on description provided by Boukhris et al 2016.
The Public Prescription Drug Insurance database of Québec (drug name, start date, dose, and duration). Data on prescription filling for AD were validated against medical records and maternal reports.
Colvin
2012 		Australia
2002 - 2005
retrospective cohort (claims database) 		A population-based study of all pregnancy events in Western Australia (WA). Children born to women who had been dispensed Fluvoxamine at any time during their pregnancy. unexposed (general population or NOS)
Children born to women who had not been dispensed a selective serotonin reuptake inhibitor (SSRI) at any time during their pregnancy. 		during pregnancy (anytime or not specified) -9 / 94561 Nb of exposed children not reported.
The national Pharmaceutical Benefits Scheme (PBS), a claims database that includes 80% of all prescriptions dispensed in Australia.
Dubnov-Raz
2008 		Israel
2000 - 2005
prospective cohort 		The Rabin Medical Center Department of Neonatology, Israel. Newborns exposed to Fluvoxamine in the immediate antepartum period. (This is a subgroup of exposure among the whole exposed group considered in the study). unexposed, disease free
Newborns born to healthy mothers who took no medications before delivery. 		days before delivery 1 / 52
Not specified.
Einarson
2009 		Canada
Not specified.
prospective cohort 		The Motherisk Program, a teratogenic information service. Pregnant women who were exposed to Fluvoxamine 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 52 / 928
During the initial telephone contact, details of exposure and concurrent exposures are recorded on a standardized 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 Fluvoxamine 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 LMP). (This is a subgroup of exposure among the whole exposed group considered in the study). unexposed (general population or NOS)
Infants not exposed to any antidepressant (ATC code N06A) in utero. 		1st trimester 255 / 2266875
The Nordic prescription registers include data on dispensed drugs, substance, brand name, and formulation, together with date of dispensing.
Källén
2007 		Sweden
1995 - 2004
population based cohort retrospective 		The Swedish Medical Birth Register, the Register of Congenital Malformations, and the Hospital Discharge Register. Pregnant women who reported the use of Fluvoxamine in early pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). unexposed (general population or NOS)
The total population. 		early pregnancy 37 / 873876 All malformations: no overlapping with Furu 2015 (including Sweden 2006-2010).
Drug information was obtained from routine midwife interviews at the first antenatal care center visit (in 90% before the end of week 12) using a standardized form.
Kieler
2012 		Denmark, Finland, Iceland, Norway, and Sweden
1996 - 2007
population based cohort retrospective 		Population based cohort study using data from the national health registers from the five Nordic countries. A filled prescription of Fluvoxamine during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). unexposed (general population or NOS)
No filled prescription of selective serotonin reuptake inhibitors (SSRIs) during pregnancy. 		2nd and/or 3rd trimester, 3 months or more before pregnancy or1st trimester 405 / 1588140
The prescription registers.
Malm
2011 		Finland
1996 - 2006
population based cohort retrospective 		An ongoing national joint project, Drugs and Pregnancy, based on three national health registers: The Medical Birth Register and the Register of Congenital Malformations and the Drug Reimbursement Register. Offspring of mothers with at least one purchase of Fluvoxamine during the period of 1 month before pregnancy and first trimester. unexposed (general population or NOS)
Offspring of mothers without purchase of one or more selective serotonin reuptake inhibitor drugs. 		1st trimester 240 / 618727 Major malformations were updated in a larger study published by Furu 2015 (1996-2010). Thus there are not reported here.
The Drug Reimbursement Register that contains data on 98% of reimbursed prescription drug purchases.
Oberlander
2008 		Canada
1997 - 2002
retrospective cohort (claims database) 		Population-based health-care utilization databases from the province of British Columbia. Infants exposed to Fluvoxamine monotherapy in the first trimester of pregnancy. unexposed (general population or NOS)
Infants with no exposure to either of these drugs (SRI or benzodiazepine) in the first trimester of pregnancy. 		1st trimester 119 / 107320
PharmaNet, a province-wide network recording all prescriptions dispensed by British Columbian pharmacists outside hospitals.
Stephansson
2013 		Nordic countries (Denmark, Finland, Iceland, Norway, and Sweden)
1996 - 2007
population based cohort retrospective 		A registry-based cohort study based on national registries of the 5 Nordic countries. One or more filled prescriptions for Fluvoxamine from 3 months before the start of pregnancy until birth (different analysis according to period of exposure). unexposed (general population or NOS)
No prescriptions for an Selective serotonin reuptake inhibitors (SSRIs). 		3 months (or more) before pregnancy or during pregnancy 394 / 1604649 Exclusion of pregnancies and births (n = 5396) of mothers who had used other antidepressants with an effect on serotonin or norepinephrine activity (but not other antidepressants).
The prescription registries in the Nordic countries include data on the dispensed item, substance, brand name, and formulation together with date of dispensing for more than 95% of the total outpatient population.
Yaris
2005 		Turkey
1999 - 2004
prospective cohort 		Toxicology Information and Follow-up Service, Turkey Women who were exposed to Fluvoxamine 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) 9 / 248 Multiple drug exposure. Raw data for Intrauterine exitus not reported because the nb of cases in the unexposed group 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
Ames
2021 		USA
2003 - 2011
case control 		The Study to Explore Early Development (SEED): a multisite case-control study of autism by the Centers for Autism and Developmental Disabilities Research and Epidemiology (CADDRE) network. Children with Autism spectrum disorder (ASD) or with other developmental delays or disorders (DDs) such as language delay or intellectual disability (ID) recruited from educational and clinical settings that serve children with developmental disorders. Children from the general population randomly sampled state birth records at each study site who either scored <11 on the SCQ or scored >=11 but did not meet ASD criteria after the in-person assessment. Maternal use of SSRIs during pregnancy were ascertained from all participants in three ways: self-report in a telephone interview shortly after study enrollment (SEED Caregiver Interview), self-report on the SEED maternal medical history form, and abstraction from prenatal medical records. 3 months (or more) before pregnancy or during pregnancy 1750 / 1671 The final analytic sample comprised 1367 children with ASD, 1750 with DDs, and 1671 POP controls. No age specified in article but in CDC website: 'The study will include children with ASD, with other DDs, and with typical development, ages 2-5 years'.
Children completed a multistage process. 1) Mother (mainly) completed the Social Communication Questionnaire. 2) Gold standard clinical assessments: Autism Diagnostic Observation Schedule, Autism Diagnostic Interview Revised, Mullen Scales of Early Learning and Vineland Adaptive Behavior Scales.
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).
De Vera
2012 		Canada
1997 - 2003
nested case control 		The Quebec Pregnancy Registry (QPR), a longitudinal cohort established with the linkage of three administrative databases. Women with a diagnosis of gestational hypertension (ICD-9: 642.3, 642.0), pre-eclampsia (ICD-9: 642.4, 642.5) or eclampsia (ICD-9: 642.6) after the 20th week of gestation. Women who did not have a diagnosis of pregnancy-induced hypertension at or before the same gestational age. The Quebec’s Public Prescription Drug Insurance Plan. during pregnancy (anytime or not specified) 1216 / 12160
Linkage of three administrative databases: (i) Régie de l’Assurance Maladie du Québec (RAMQ), (ii) MED-ECHO and (iii) Institut de la Statistique du Québec (ISQ).
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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