Paroxetine


Study Exclusion reasons Rmk Reference
Bérard (Controls exposed to SNRI or SSRI other than Paroxetine), 2007 inadequate or absent control group EXCLUDED: non exposed group: exposed to i) SSRI other than Paroxetine; ii) or non-SSRI antidepressants (mainly venlafaxine (37%) or amitriptyline (33%)), which are not considered as relevant control groups.

Bérard A Birth Defects Res B Dev Reprod Toxicol 2007;80:18-27 10.1002/bdrb.20099

Cole, 2007 inadequate or absent control group EXCLUDED: control group was exposed to other antidepressants (NOS), probably with Selective serotonin reuptake inhibitors (SSRIs), which are not an adequate comparison group for Paroxetine which is also a SSRI.

Cole JA Pharmacoepidemiol Drug Saf 2007;16:1075-85 10.1002/pds.1463

Malm, 2005 repeat population groups, duplicate reports (most recent study included) EXCLUDED: overlapping. Data are included in a larger study: Furu 2015 (malformations in 5 Nordic countries, including Finland) concerning a longer period (1996 - 2010) and more exposed pregnancies. For medical care outcome: ni adequate control group.

Malm H Obstet Gynecol 2005;106:1289-96 10.1097/01.AOG.0000187302.61812.53

Diav-Citrin, 2005 repeat population groups, duplicate reports (most recent study included) EXCLUDED: a more detailed and updated study was published by Diav-Cirtin 2008, based more exposed pregnancies.

Diav-Citrin Reprod Toxicol. 2005;20:459. Abstract.

Kallen, 2006 repeat population groups, duplicate reports (most recent study included) EXCLUDED: Overlapping: data on 'any malformations' included in a more detailed and updated article Kallen 2007 and 'Cardiovascular malformations' included in a larger study (Furu 2015) based on 5 nordic databases and more exposed pregnancies.

Källen B Reprod Toxicol 2006;21:221-2 10.1016/j.reprotox.2005.11.006

Bakker, 2006 repeat population groups, duplicate reports (most recent study included) EXCLUDED: a more detailed and updated study was published by Bakker 2010, based on a longer period and included more cases and controls.

Bakker Pharmacoepidemiol Drug Safety 2006 15:S81.

Ramos, 2008 repeat population groups, duplicate reports (most recent study included) Overlapping: Data updated by Bérard 2017.

Ramos Br J Psychiatry 2008; 192:344-50 10.1192/bjp.bp.107.042523

Pedersen, 2009 repeat population groups, duplicate reports (most recent study included) EXCLUDED: Data from Denmark (1996–2003) => Included in a larger study published by Furu 2015 (data from Nordic population (Denmark, Finland, Iceland, Norway, and Sweden) between1996-2010).

Pedersen BMJ 2009; 339:b3569 10.1136/bmj.b3569

Kornum, 2010 repeat population groups, duplicate reports (most recent study included) EXCLUDED: data of Northern Denmark (approximately 31% of the Danish population) between 1991–2007, mainly included in the entire Danish nationwide cohort study (1997-2009) published by Jimenez-Solem 2012.

Kornum JB Clin Epidemiol 2010;2:29-36

Schloemp, 2006 same data already obtained by other studies EXCLUDED: these data are largely included in a larger study published by Diav-Cirtin 2008 (Israel, Italy and Germany) that include more exposed pregnancies.

Schloemp Hum Reprod. 2006;21(Suppl I):ii 2. ESHRE abstract O-030.

Cole, 2006 same data already obtained by other studies EXCLUDED: an entire publication, more detailed that this abstract was published by Cole 2007.

Cole Pharmacoepidemiol Drug Sa F 2006;15(51):S6.Abstract. 10.1002/pds.1295

Berard, 2006 same data already obtained by other studies EXCLUDED: an entire publication, more detailed that this abstract was published by Cole 2007.

Berard Birth Defects Res A Clin Mol Teratol. 2006;76:335. Abstract.

Nash, 2007 article unavailable EXCLUDED: abstract of congress not available (an other article of Nash in Acta paediatrica, 2007;96(S456) did not provide enough details to be reported).

Nash 2007 Paediatr Child Health 12(SA):42.

Knudsen, 2014 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: analysis of SSRI as a whole, without distinction between substances.

Knudsen TM BMC Pregnancy Childbirth 2014;14:333 10.1186/1471-2393-14-333

Simon, 2002 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: analysis of SSRI as a whole, without distinction between substances.

Simon GE Am J Psychiatry 2002;159:2055-61 10.1176/appi.ajp.159.12.2055

Kulin, 1998 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: analysis of SSRI as a whole, without distinction between substances.

Kulin NA JAMA 1998;279:609-10

Casper, 2003 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: analysis of SSRI as a whole, without distinction between substances.

Casper RC J Pediatr 2003;142:402-8 10.1067/mpd.2003.139

Louik, 2006 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: analysis of SSRI as a whole, without distinction between substances.

Louik Pharmacoepidemiol Drug Safety 2006 15:S81