Systematic meta-analysis of individual selective serotonin reuptake inhibitor medications and congenital malformations

Australian and New Zealand Journal of Psychiatry

Volumn 47, Issue 11, 2013, Pages 1002-1012

  Myles, Nicholas ^a   Newall, Hannah ^a   Ward, Harvey ^b   Large, Matthew ^c  

^a QUEEN ELIZABETH HOSPITAL   (Australia)

^b Coffs Harbour Health Campus ^*  (Australia)

^c PRINCE OF WALES HOSPITAL   (Australia)

Author keywords

Antidepressant; fluoxetine; malformation; paroxetine; SSRI; teratogen

Indexed keywords

CITALOPRAM; FLUOXETINE; PAROXETINE; SEROTONIN UPTAKE INHIBITOR; SERTRALINE;

CARDIAC MALFORMATION; CINAHL; CONGENITAL HEART MALFORMATION; CONGENITAL MALFORMATION; EMBASE; FEMALE; HUMAN; MEDLINE; META ANALYSIS; PREGNANCY OUTCOME; PREGNANT WOMAN; PRENATAL EXPOSURE; PSYCINFO; REVIEW; SYSTEMATIC REVIEW; TERATOGENICITY;

ANTIDEPRESSANT; FLUOXETINE; MALFORMATION; PAROXETINE; SSRI; TERATOGEN;

ABNORMALITIES, DRUG-INDUCED; HEART DEFECTS, CONGENITAL; HUMANS; SEROTONIN UPTAKE INHIBITORS;

EID: 84887249951     PISSN: 00048674     EISSN: 14401614     Source Type: Journal    
DOI: 10.1177/0004867413492219     Document Type: Review

References (53)

1. Addis A, Koren G. Safety of fluoxetine during the first trimester of pregnancy: a meta-analytical review of epidemiological studies. Psychological Medicine. 2000 ; 30: 89-94
2. Alwan S, Reefhuis J, Rasmussen SA, et al. Use of selective serotonin-reuptake inhibitors in pregnancy and the risk of birth defects. New England Journal of Medicine. 2007 ; 356: 2684-2692
3. Andrade SE, Raebel MA, Brown J, et al. Use of antidepressant medications during pregnancy: a multisite study. American Journal of Obstetrics and Gynecology 198. 2008 ; 194: e1 - e5
4. Bar-Oz B, Einarson T, Einarson A, et al. Paroxetine and congenital malformations: meta-Analysis and consideration of potential confounding factors. Clinical Therapeutics. 2007 ; 29: 918-926
5. Bennett HA, Einarson A, Taddio A, et al. Prevalence of depression during pregnancy: systematic review. Obstetrics and Gynecology. 2004 ; 103: 698-709
6. Berard A, Ramos E, Rey E, et al. First trimester exposure to paroxetine and risk of cardiac malformations in infants: the importance of dosage. Birth Defects Research B. 2007 ; 80: 18-27
7. Bonari LP, Pinto N, Ahn NE, et al. Perinatal risks of untreated depression during pregnancy. Canadian Journal of Psychiatry. 2004 ; 49: 726-735
8. Bradburn MJ, Deeks JJ, Berlin JA, et al. Much ado about nothing: a comparison of the performance of meta-analytical methods with rare events. Statistics in Medicine. 2007 ; 15: 53-77
9. Chun-Fai-Chan B, Koren G, Fayez I, et al. Pregnancy outcome of women exposed to bupropion during pregnancy: a prospective comparative study. American Journal of Obstetrics and Gynecology. 2005 ; 192: 932-936
10. Cohen LS, Altshuler LL, Harlow BL, et al. Relapse of major depression during pregnancy in women who maintain or discontinue antidepressant treatment. JAMA. 2006 ; 295: 499-507
11. Cole JA, Modell JG, Haight BR, et al. Bupropion in pregnancy and the prevalence of congenital malformations. Pharmacoepidemiology and Drug Safety. 2007 ; 16: 474-484
12. Costei AM, Kozer E, Ho T, et al. Perinatal outcome following third trimester exposure to paroxetine. Archives of Pediatrics and Adolescent Medicine. 2002 ; 156: 1129-1132
13. Davis RL, Rubanowisc D, McPhillips H, et al. Risks of congenital malformations and perinatal events among infants exposed to antidepressant medications during pregnancy. Pharmacoepidemiology and Drug Safety. 2007 ; 16: 1086-1094
14. Detrait ER, George TM, Etchevers HC, et al. Human neural tube defects: developmental biology, epidemiology and genetics. Neurotxicology and Teratology. 2005 ; 27: 515-524
15. Diav-Citran O, Shechtman S, Weinbaum D, et al. Paroxetine and fluoxetine in pregnancy: a prospective, multicentre, controlled, observational study. British Journal of Clinical Pharmacology. 2008 ; 66: 695-705
16. Dimidjian S, Hollon SG, Dobson KS, et al. Randomized trial of behavioral activation, cognitive therapy, and antidepressant medication in the acute treatment of adults with major depression. Journal of Consulting and Clinical Psychology. 2006 ; 74: 658-670
17. Djulus J, Koren G, Einarson TR, et al. Exposure to mirtazapine during pregnancy: a prospective, comparative study of birth outcomes. Journal of Clinical Psychiatry. 2006 ; 67: 1280-1284
18. Einarson A, Bonari L, Voyer-Lavigne S, et al. A multicentre prospective controlled study to determine the safety of trazodone and nefazodone use during pregnancy. Canadian Journal of Psychiatry. 2003 ; 48: 106-110
19. Einarson A, Fatoye B, Sarkar M, et al. Pregnancy outcome following gestational exposure to venlafaxine: a multicenter prospective controlled study. American Journal of Psychiatry. 2001a ; 158: 1728-1730
20. Einarson A, Selby P, Koren G. Abrupt discontinuation of psychotropic drugs during pregnancy: fear of teratogenic risk and impact of counselling. Journal of Psychiatry and Neuroscience. 2001b ; 26: 44-48
21. Einarson TR, Einarson A. Newer antidepressants in pregnancy and rates of major malformations: a meta-analysis of prospective comparative studies. Pharmacoepidemiology and Drug Safety. 2005 ; 14: 823-827
22. Gentile S. Selective serotonin reuptake inhibitor exposure during pregnancy and the risk of birth defects. Acta Psychiatrica Scandinavica. 2011 ; 123: 266-275
23. Goldstein DJ, Corbin LA, Sundell KL. Effects of first-trimester fluoxetine exposure on the newborn. Obstetrics and Gynecology. 1997 ; 89: 713-718
24. Kallen BA, Otterblad Olausson P. Maternal drug use in early pregnancy and infant cardiovascular defect. Reproductive Toxicology. 2003 ; 17: 255-261
25. Kallen BA, Otterblad Olausson P. Maternal use of selective serotonin re-uptake inhibitors in early pregnancy and infant congenital malformations. Birth Defects Research. 2007 ; 79: 301-308
26. Kulin NA, Pastuszak A, Sage SR, et al. Pregnancy outcome following maternal use of the new selective serotonin reuptake inhibitors: a prospective controlled multicenter study. JAMA. 1998 ; 279: 609-610
27. Lee DT, Chung TK. Postnatal depression: an update. Best Practice and Research in Clinical Obstetrics and Gynaecology. 2007 ; 21: 183-191
28. Louik C, Lin AE, Werler MM, et al. First-trimester use of selective serotonin-reuptake inhibitors and the risk of birth defects. New England Journal of Medicine. 2007 ; 356: 2675-2683
29. Malm H, Klaukka T, Neuvonen PJ. Risks associated with selective serotonin reuptake inhibitors in pregnancy. Obstetrics and Gynecology. 2005 ; 106: 1289-1296
30. Malm HA, Artama M, Gissler M, et al. Selective serotonin reuptake inhibitors and risk for major congenital anomalies. Obstetrics and Gynecology. 2011 ; 118: 111-120
31. Maschi S, Clavenna A, Campi R, et al. Neonatal outcome following pregnancy exposure to antidepressants: a prospective controlled cohort study. BJOG: An International Journal of Obstetrics and Gynaecology. 2008 ; 115: 283-289
32. Merlob P, Birk E, Sirota L, et al. Are selective serotonin reuptake inhibitors cardiac teratogens? Echocardiographic screening of newborns with persistent heart murmur. Birth Defects Research. 2009 ; 85: 837-841
33. Murray L, Cooper P J. Postpartum depression and child development. Psychological Medicine. 1997 ; 27: 253-260
34. O'Brien LE, Einarson TR, Sarka TR, et al. Does paroxetine cause cardiac malformations?. Journal of Obstetrics and Gynaecology Canada. 2008 ; 30: 696-701
35. Oberlander TF, Misri S, Fitzgerald CE, et al. Pharmacologic factors associated with transient neonatal symptoms following prenatal psychotropic medication exposure. Journal of Clinical Psychiatry. 2004 ; 65: 230-237
36. Pastuszak A, Schick-Boschetto B, Zuber C, et al. Pregnancy outcome following first-trimester exposure to fluoxetine (Prozac). JAMA. 1993 ; 269: 2246-2248
37. Pedersen LH, Henriksen TB, Vestergaard M, et al. Selective serotonin reuptake inhibitors in pregnancy and congenital malformations: population based cohort study. BMJ. 2009 ; 339: b3569
38. Pradat P, Francannet C, Harris JA. The epidemiology of cardiovascular defects, Part I: a study based on data from three large registries of congenital malformations. Pediatric Cardiology. 2003 ; 24: 195-221
39. Queisser-Luft A, Stolz A, Wiesel K, et al. Malformations in newborn: results based on 30,940 infants and fetuses from the Mainz congenital birth defect monitoring system (1990-1998). Archives of Gynecology and Obstetrics. 2002 ; 266: 163-167
40. Rahimi R, Nikfar S, Abdollahi M. Pregnancy outcomes following exposure to serotonin reuptake inhibitors: a meta-analysis of clinical trials. Reproductive Toxicology. 2006 ; 22: 571-575
41. Ramos E, St-Andre M, Rey E, et al. Duration of antidepressant use during pregnancy and risk of major congenital malformations. British Journal of Psychiatry. 2008 ; 192: 344-350
42. Reis M, Kallen B. Delivery outcome after maternal use of antidepressant drugs in pregnancy: an update using Swedish data. Psychological Medicine. 2010 ; 40: 1723-1733
43. Rosano A, Botto L, Botting B, et al. Infant mortality and congenital anomalies from 1950 to 1994: an international perspective. Journal of Epidemology and Community Health. 2000 ; 54: 660-666
44. Simon GE, Cunningham ML, Davis RL. Outcomes of prenatal antidepressant exposure. American Journal of Psychiatry. 2002 ; 159: 2055-2061
45. Stroup DF, Berlin JA, Morton SC, et al. Meta-analysis of observational studies in epidemiology: a proposal for reporting. Meta-analysis Of Observational Studies in Epidemiology (MOOSE) group. JAMA. 2000 ; 283: 2008-2012
46. Sutton AJ, Duval SJ, Tweedie RL, et al. Empirical assessment of effect of publication bias on meta-analyses. BMJ. 2000 ; 320: 1574-1577
47. Tuccori M, Montagnani A, Testi A, et al. Use of selective serotonin inhibitors during pregnancy and risk of major and cardiovascular malformations: an update. Postgraduate Medicine. 2010 ; 122: 49-65
48. Udechuku A, Hill R, Szego K, et al. Antidepressants in pregnancy: a systematic review. Australian and New Zealand Journal of Psychiatry. 2011 ; 44: 978-996
49. Wen SW, Yang Q, Garner P, et al. Selective serotonin reuptake inhibitors and adverse pregnancy outcomes. American Journal of Obstetrics and Gynecology. 2006 ; 194: 961-966
50. Wichman CL, Moore KM, Lang TR, et al. Congenital heart disease associated with selective serotonin reuptake inhibitor use during pregnancy. Mayo Clinic Proceedings. 2009 ; 84: 23-27
51. Wisner KL, Sit DK, Hanusa BH, et al. Major depression and antidepressant treatment: impact on pregnancy and neonatal outcomes. American Journal of Psychiatry. 2009 ; 166: 557-566
52. Wogelius P, Norgaard M, Gislum M, et al. Maternal use of selective serotonin reuptake inhibitors and risk of congenital malformations. Epidemiology. 2006 ; 17: 701-704
53. Wurst KE, Poole C, Ephross SA, et al. First trimester paroxetine use and the prevalence of congenital, specifically cardiac, defects: a meta-analysis of epidemiological studies. Birth Defects Research. 2010 ; 88: 159-170