Antidepressant use during pregnancy: The benefit-risk ratio

American Journal of Obstetrics and Gynecology

Volumn 207, Issue 3, 2012, Pages 157-163

  Koren, Gideon ^a   Nordeng, Hedvig ^b  

^a HOSPITAL FOR SICK CHILDREN   (Canada)

^b UNIVERSITY OF OSLO   (Norway)

Author keywords

antidepressant; depression; malformation; persistent pulmonary hypertension of the newborn infant (PPHN); pregnancy; risk

Indexed keywords

ANTIDEPRESSANT AGENT; CITALOPRAM; ESCITALOPRAM; FLUOXETINE; FLUVOXAMINE; PAROXETINE; SEROTONIN NORADRENALIN REUPTAKE INHIBITOR; SEROTONIN UPTAKE INHIBITOR; SERTRALINE; VENLAFAXINE;

ADAPTATION SYNDROME; ANENCEPHALUS; CARDIOVASCULAR DISEASE; CARDIOVASCULAR MALFORMATION; CARDIOVASCULAR RISK; CONGENITAL MALFORMATION; CRANIOFACIAL SYNOSTOSIS; DEPRESSION; DRUG EFFECT; DRUG USE; ENVIRONMENTAL EXPOSURE; EVIDENCE BASED MEDICINE; FEMALE; GASTROSCHISIS; HEART ATRIUM SEPTUM DEFECT; HEART VENTRICLE SEPTUM DEFECT; HUMAN; PREGNANCY; PRENATAL EXPOSURE; PRIORITY JOURNAL; PULMONARY HYPERTENSION; REVIEW; SIDE EFFECT;

ABNORMALITIES, DRUG-INDUCED; ANTIDEPRESSIVE AGENTS; DEPRESSION; FEMALE; FETAL DISEASES; HUMANS; ODDS RATIO; PREGNANCY; PREGNANCY COMPLICATIONS; RISK ASSESSMENT;

EID: 84865735200     PISSN: 00029378     EISSN: 10976868     Source Type: Journal    
DOI: 10.1016/j.ajog.2012.02.009     Document Type: Review

References (75)

1. J. Evans, J. Heron, H. Francomb, S. Oke, J. Golding Cohort study of depressed mood during pregnancy and after childbirth BMJ 323 2001 257 260
2. W.O. Cooper, M.E. Willy, S.J. Pont, W.A. Ray Increasing use of antidepressants in pregnancy Am J Obstet Gynecol 196 2007 544.e1 544.e5
3. G. Koren, A. Pastuszak, S. Ito Drugs in pregnancy N Engl J Med 338 1998 1128 1137
4. S. Kasper, J. Fuger, H.J. Moller Comparative efficacy of antidepressants Drugs 43 1992 11 22
5. M.S. McKenzie, B.H. McFarland Trends in antidepressant overdoses Pharmacoepidemiol Drug Saf 16 2007 513 523
6. J. Reefhuis, S.A. Rasmussen, J.M. Friedman Selective serotonin-reuptake inhibitors and persistent pulmonary hypertension of the newborn N Engl J Med 354 2006 2188 2190
7. S.E. Andrade, M.A. Raebel, J. Brown Use of antidepressant medications during pregnancy: a multisite study Am J Obstet Gynecol 198 2008 194.e1 194.e5
8. I. Nulman, J. Rovet, D.E. Stewart Neurodevelopment of children exposed in utero to antidepressant drugs N Engl J Med 336 1997 258 262
9. A. Pastuszak, B. Schick-Boschetto, C. Zuber Pregnancy outcome following first-trimester exposure to fluoxetine (Prozac) JAMA 269 1993 2246 2248
10. N.A. Kulin, A. Pastuszak, S.R. Sage Pregnancy outcome following maternal use of the new selective serotonin reuptake inhibitors: a prospective controlled multicenter study JAMA 279 1998 609 612
11. Food and Drug Administration 2005 Public health advisory Paxil www.fda.gov/Drugs/DrugSafetyInformationforPatientsandProviders/ DrugSafetyInformationforHealthcareProfessionals/PublicHealthAdvisories/ ucm051731.htm Accessed Nov. 6, 2011
12. O. Diav-Citrin, A. Ornoy Selective serotonin reuptake inhibitors in human pregnancy: to treat or not to treat Obstet Gynecol Int 2012 698947 [Epub 2011 Dec 10].
13. A. Einarson, A. Pistelli, M. DeSantis Evaluation of the risk of congenital cardiovascular defects associated with use of paroxetine during pregnancy Am J Psychiatry 165 2008 749 752
14. C.D. Chambers, S. Hernandez-Diaz, L.J. Van Marter Selective serotonin-reuptake inhibitors and risk of persistent pulmonary hypertension of the newborn N Engl J Med 354 2006 579 587
15. D.J. Goldstein, K.L. Sundell, L.A. Corbin Birth outcomes in pregnant women taking fluoxetine N Engl J Med 336 1997 872 873
16. L.V. Wilton, G.L. Pearce, R.M. Martin, F.J. Mackay, R.D. Mann The outcomes of pregnancy in women exposed to newly marketed drugs in general practice in England BJOG 105 1998 882 889
17. A. Ericson, B. Kallen, B. Wiholm Delivery outcome after the use of antidepressants in early pregnancy Eur J Clin Pharmacol 55 1999 503 508
18. C.L. Unfred, C.D. Chambers, R. Felix Birth outcomes among pregnant women taking paroxetine (Paxil): OTIS 14th Annual Meeting Proceedings Teratology 63 2001 321 324
19. H. Malm, T. Klaukka, P.J. Neuvonen Risks associated with selective serotonin reuptake inhibitors in pregnancy Obstet Gynecol 106 2005 1289 1296
20. A. Sivojelezova, S. Shuhaiber, L. Sarkissian, A. Einarson, G. Koren Citalopram use in pregnancy: prospective comparative evaluation of pregnancy and fetal outcome Am J Obstet Gynecol 193 2005 2004 2009
21. P. Wogelius, M. Norgaard, M. Gislum Maternal use of selective serotonin reuptake inhibitors and risk of congenital malformations Epidemiology 17 2006 701 704
22. S.W. Wen, Q. Yang, P. Garner Selective serotonin reuptake inhibitors and adverse pregnancy outcome Am J Obstet Gynecol 194 2006 961 966
23. S. Schloemp, W.E. Paulus, K. Sterzik, F. Stoz Congenital malformations after antidepressant medication with paroxetine in early pregnancy? Hum Reprod 21 suppl 1 2006 i12
24. T. Vial, M.P. Cournot, N. Bernard Paroxetine and congenital malformations: a prospective comparative study Drug Saf 29 2006 970
25. B. Kallen, P. Otterblad-Olausson Antidepressant drugs during pregnancy and infant congenital heart defects Reprod Toxicol 21 2006 221 222
26. B. Kallen, P. Otterblad-Olausson Maternal use of selective serotonin re-uptake inhibitors in early pregnancy and infant congenital malformations Birth Defects Res A Clin Mol Teratol 79 2007 301 308
27. R.L. Davis, D. Rubanowice, H. McPhillips Risks of congenital malformations and perinatal events among infants exposed to antidepressant medications during pregnancy Pharmacoepidemiol Drug Saf 16 2007 1086 1094
28. A. Berard, E. Ramos, E. Rey, L. Blais, M. St-Andre, D. Oraichi First trimester exposure to paroxetine and risk of cardiac malformations in infants: the importance of dosage Birth Defects Res B Dev Reprod Toxicol 80 2007 18 27
29. S. Alwan, J. Reefhuis, S.A. Rassmussen, R.S. Olney, J.M. Friedman Use of selective serotonin-reuptake inhibitors in pregnancy and risk of birth defects N Engl J Med 356 2007 2684 2692
30. GlaxoSmithKline Bupropion and paroxetine; study ID 113694-3 WWE113694/WE661/EP140217; epidemiology study: final report on bupropion and other antidepressants, including paroxetine, in pregnancy and the occurrence of cardiovascular and major congenital malformations www.gsk-clinicalstudyregister. com Accessed May 18, 2011
31. J.A. Cole, S.A. Ephross, I.A. Cosmatos, A.M. Walker Paroxetine in the first trimester and the prevalence of congenital malformations Pharmacoepidemiol Drug Saf 16 2007 1075 1085
32. C. Louik, A.E. Lin, M.M. Werler, S. Hernandez-Diaz, A.A. Mitchell First-trimester use of selective serotonin-reuptake inhibitors and risk of birth defects N Engl J Med 356 2007 2675 2683
33. O. Diav-Citrin, S. Shechtman, D. Weinbaum Paroxetine and fluoxetine in pregnancy: a prospective multicentre, controlled, observational study Br J Clin Pharmacol 66 2008 695 705
34. T.F. Oberlander, W. Warburton, S. Misri, W. Riggs, J. Aghajanian, C. Hertzman Major congenital malformations following prenatal exposure to serotonin reuptake inhibitors and benzodiazepines using population-based health data Birth Defects Res B Dev Reprod Toxicol 83 2008 68 76
35. L.H. Pedersen, T.B. Henriksen, M. Westergaard, J. Olsen, B.H. Bech Selective serotonin reuptake inhibitors in pregnancy and congenital malformations: population based cohort study BMJ 339 2009 b3569
36. C.L. Wichman, K.M. Moore, T.R. Lang, J.L. St Sauver, R.H. Heise Jr, W.J. Watson Congenital heart disease associated with selective serotonin reuptake inhibitor use during pregnancy Mayo Clin Proc 84 2009 23 27
37. P. Merlob, E. Birk, L. Sirota Are selective serotonin reuptake inhibitors cardiac teratogens? Echocardiographic screening of newborns with persistent heart murmur Birth Defects Res A Clin Mol Teratol 85 2009 837 841
38. C. Klieger-Grossmann, B. Weitzner, T. Einarson, G. Koren, A. Einarson The safety of escitalopram in pregnancy: a prospective cohort study Birth Defects Res A Clin Mol Teratol 88 2010 363
39. J.B. Kornum, R.B. Nielsen, L. Pedersen, P.B. Mortensen, M. Norgaard Use of selective serotonin-reuptake inhibitors during early pregnancy and risk of congenital malformations: updated analysis Clin Epidemiol 2 2010 29 36
40. M.K. Bakker, W.S. Kerstjens-Frederikse, C.H. Buys, H.E. de Walle, L.T. de Jong-van den Berg First trimester use of paroxetine and congenital heart defects: a population-based case-control study Birth Defects Res A Clin Mol Teratol 88 2010 94 100
41. M. Reis, B. Kallen Delivery outcome after maternal use of antidepressant drugs in pregnancy: an update using Swedish data Psychol Med 40 2010 1723 1733
42. S. Shechtman, U. Sabbah, O. Diav-Citrin, A. Ornoy Lack of teratogenic effect of citalopram/escitalopram after in utero exposure Reprod Toxicol 31 2011 265
43. H. Malm, M. Artama, M. Gissler, A. Ritvanen Selective serotonin reuptake inhibitors and risk for major congenital anomalies Obstet Gynecol 118 2011 111 120
44. K.E. Wurst, C. Poole, S.A. Ephross, A.F. Olshan First trimester paroxetine use and the prevalence of congenital, specifically cardiac, defects: a meta-analysis of epidemiological studies Birth Defects Res A Clin Mol Teratol 88 2010 159 170
45. A.R. Schialli Paroxetine exposure and during pregnancy and cardiac malformations Birth Defects Res A Clin Mol Teratol 88 2010 175 177
46. B. Kallen, E. Nilsson, P. Otterblad-Olausson Antidepressant use during pregnancy: comparison of data obtained from a prescription register and from antenatal care records Eur J Clin Pharmacol 67 2011 839 845
47. L. Osterberg, T. Blaschke Adherence to medication N Engl J Med 353 2005 487 497
48. B. Bar-Oz, T. Einarson, A. Einarson Paroxetine and congenital malformations: meta-analysis and consideration of potential confounding factors Clin Ther 29 2007 918 926
49. J. Belik Fetal and neonatal effects of maternal drug treatment for depression Semin Perinatol 32 2008 350 354
50. B. Kallen, P.O. Olausson Maternal use of selective serotonin re-uptake inhibitors and persistent pulmonary hypertension of the newborn Pharmacoepidemiol Drug Saf 17 2008 801 806
51. K.L. Wilson, C.M. Zelig, J.P. Harvey, B.S. Cunningham, B.M. Dolinsky, P.G. Napolitano Persistent pulmonary hypertension of the newborn is associated with mode of delivery and not with maternal use of selective serotonin reuptake inhibitors Am J Perinatol 28 2011 19 24
52. P. Therese Persistent pulmonary hypertension of the newborn Paediatr Respir Rev 1 2006 S175 S176
53. G. Koren, Y. Finkelstein, D. Matsui, M. Berkovich Diagnosis and management of poor neonatal adaptation syndrome in newborns exposed in utero to selective serotonin/norepinephrine reuptake inhibitors J Obstet Gynaecol Can 31 2009 348 350
54. A.M. Costei, E. Kozer, T. Ho, S. Ito, G. Koren Perinatal outcome following third trimester exposure to paroxetine Arch Pediatr Adolesc Med 156 2002 1129 1132
55. N. Boucher, G. Koren, L. Beaulac-Baillargeon Maternal use of venlafaxine near term: correlation between neonatal effects and plasma concentrations Ther Drug Monit 31 2009 404 409
56. D.C. Knoppert, R. Nimkar, T. Principi, D. Yuen Paroxetine toxicity in a newborn after in utero exposure: clinical symptoms correlate with serum levels Ther Drug Monit 28 2006 5 7
57. I. Nulman, J. Rovet, D.E. Stewart Child development following exposure to tricyclic antidepressants or fluoxetine throughout fetal life: a prospective, controlled study Am J Psychiatry 159 2002 1889 1895
58. Nulman I, Barrera M, Koren G, Feldman B. Unexposed siblings as controls for genetic confounders in studies on safety of psychotropic medications in pregnancy: novel methodology in behavioral teratology: session LBII-A-4. ASCPT Annual Meeting; Washington, DC: March 21, 2009.
59. C. Gedeon, G. Koren Gestational changes in drug disposition in the maternal-fetal unit G. Koren, Medication safety in pregnancy and breastfeeding 2007 McGraw Hill New York 5 12
60. L. Lorenzo, B. Byers, A. Einarson Antidepressant use in pregnancy Expert Opin Drug Saf 10 2011 883 889
61. A. Einarson, P. Selby, G. Koren Discontinuing antidepressants and benzodiazepines upon becoming pregnant Beware of the risks of abrupt discontinuation Can Fam Physician 47 2001 489 490
62. L.S. Cohen, L.L. Altshuler, B.L. Harlow Relapse of major depression during pregnancy in women who maintain or discontinue antidepressant treatment JAMA 295 2006 499 507
63. H. Cox, J.M. Holden, R. Sagovsky Detection of postnatal depression: development of the 10-item Edinburgh Postnatal Depression Scale J Psychiatry 150 1987 782 786
64. A. Walfisch, C. Sermer, I. Matok, G. Koren, A. Einarson Screening for depressive symptoms Can Fam Physician 57 2011 777 778
65. G. Koren, M. Bologa, D. Long, Y. Feldman, N.H. Shear Perception of teratogenic risk by pregnant women exposed to drugs and chemicals during the first trimester Am J Obstet Gynecol 160 1989 1190 1194
66. G. Koren, A. Pastuszak Prevention of unnecessary pregnancy terminations by counseling women on drug, chemical, and radiation exposure during the first trimester Teratology 41 1990 657 661
67. L. Bonari, G. Koren, T.R. Einarson, J.D. Jasper, A. Taddio, A. Einarson Use of antidepressants by pregnant women: evaluation of perception of risk, efficacy of evidence based counseling and determinants of decision making Arch Women Ment Health 8 2005 214 220
68. R. Axt-Fliedner, A. Schwarze, J. Smrcek, U. Germer, M. Krapp, U. Gembruch Isolated ventricular septal defects detected by color Doppler imaging: evolution during fetal and first year of postnatal life Ultrasound Obstet Gynecol 27 2006 266 273
69. National Vital Statistics Reports www.cdc.gov/nchs/nvss/mortality-tables. htm Accessed Oct. 20, 2011
70. A. Mykletun, O. Bjerkeset, M. Dewey, M. Prince, S. Overland, R. Stewart Anxiety, depression, and cause-specific mortality: the Hunt study Psychosomatic Med 69 2007 323 331
71. R. Suri, G. Hellemann, Z.N. Stowe, L.S. Cohen, A. Aquino, L.L. Altshuler A prospective, naturalistic, blinded study of early neurobehavioral outcomes for infants following prenatal antidepressant exposure J Clin Psychiatry 72 2011 1002 1007
72. S. Ito, G. Koren A novel index for expressing exposure of the infant to drugs in breast milk Br J Clin Pharmacol 38 1994 99 102
73. Lactmed http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT Accessed Nov. 6, 2011
74. A. Lee, J. Woo, S. Ito Frequency of infant adverse events that are associated with citalopram use during breast-feeding Am J Obstet Gynecol 190 2004 218 221
75. American Academy of Pediatrics Transfer of drugs and other chemicals into human milk Pediatrics 110 2002 1030