Fluvoxamine - Medication and Pregnancy KB

Fluvoxamine

Exposed non-exposed studies (cohort)

Study	Country Study period	Population source	Exposure definition	Non-exposure definition	Sample size	Rmk
Bérard, 2017	Canada 1998 - 2009	Pregnancies with continuous prescription drug insurance coverage of at least 12 months before the 1DLMP and during pregnancy; pregnancies with a diagnosis of depression and/or anxiety or exposed to antidepressants in the 12 months before pregnancy.	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.	55 / 14847	Overlapping: results of Ramos 2008 (1998-2002) are included in this larger study.
Bérard, 2016	Canada 1998 - 2009	All full-term (≥37 weeks’ gestation) singleton infants born during the study period and whose mothers were covered by the RAMQ drug plan for at least 12 months before and during pregnancy.	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.	35 / 142716	Material and methods based on description provided by Boukhris et al 2016.
Colvin, 2012	Australia 2002 - 2005	All births in Western Australia during the study period.	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.	-9 / 94561	Nb of exposed children not reported.
Dubnov-Raz, 2008	Israel 2000 - 2005	All of the newborns born at a single tertiary care hospital.	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.	1 / 52
Einarson, 2009	Canada Not specified.	Women call the service for information regarding the safety of a drug.	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.	52 / 928
Furu, 2015	Denmark, Finland, Iceland, Norway, and Sweden 1996 - 2010	Women who gave birth to a live singleton infant during the study period (different periods according to country).	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.	255 / 2266875
Källén, 2007	Sweden 1995 - 2004	Nearly all deliveries in Sweden during the study period.	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.	37 / 873876	All malformations: no overlapping with Furu 2015 (including Sweden 2006-2010).
Kieler, 2012	Denmark, Finland, Iceland, Norway, and Sweden 1996 - 2007	All singletons born after 231 gestational days (33 weeks).	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.	405 / 1588140
Malm, 2011	Finland 1996 - 2006	All the Finnish births and terminations attributable to severe fetal anomalies during the study period.	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.	240 / 618727	Major malformations were updated in a larger study published by Furu 2015 (1996-2010). Thus there are not reported here.
Oberlander, 2008	Canada 1997 - 2002	About (92.7%) all live births (hospital and home births) in British Columbia during the study period.	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.	119 / 107320
Stephansson, 2013	Nordic countries (Denmark, Finland, Iceland, Norway, and Sweden) 1996 - 2007	All singletons born after 154 gestational days during the study period.	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).	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).
Yaris, 2005	Turkey 1999 - 2004	Pregnant women calling for a counseling about the teratogenic risks of drugs, chemicals, and X-ray.	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.	9 / 248	Multiple drug exposure. Raw data for Intrauterine exitus not reported because the nb of cases in the unexposed group not clearly stated.

Case-control studies (cohort)

Study	Country Study period	Case	Control	Sample size	Rmk
Ames, 2021	USA 2003 - 2011	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.	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'.
Dandjinou, 2019	Canada 1998 - 2015	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.	20905 / 209050	The 10 categories of exposure were mutually exclusive.
De Vera, 2012	Canada 1997 - 2003	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.	1216 / 12160
Nakhai-Pour, 2010	Canada 1998 - 2003	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.	5124 / 51240

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