Risks of congenital malformations and perinatal events among infants exposed to antidepressant medications during pregnancy

Pharmacoepidemiology and Drug Safety

Volumn 16, Issue 10, 2007, Pages 1086-1094

  Davis, Robert L ^a,h   Rubanowice, David ^a   McPhillips, Heather ^b   Raebel, Marsha A ^c   Andrade, Susan E ^d   Smith, David ^c   Yood, Marianne Ulcickas ^e   Platt, Richard ^f,g  

^a CENTER FOR HEALTH STUDIES   (United States)

^b UNIVERSITY OF WASHINGTON SCHOOL OF MEDICINE   (United States)

^c KAISER PERMANENTE   (United States)

^d UNIVERSITY OF MASSACHUSETTS MEDICAL SCHOOL   (United States)

^e HENRY FORD HEALTH SYSTEM   (United States)

^f HARVARD MEDICAL SCHOOL   (United States)

^g BRIGHAM AND WOMEN S HOSPITAL   (United States)

^h Southeast 10 Piedmont Center   (United States)

Author keywords

Anomalies; Antidepressants; Drug safety; Malformation; Perinatal; Pregnancy; Prescription drug

Indexed keywords

ANTIDEPRESSANT AGENT; GLUCOSE; PAROXETINE; SEROTONIN UPTAKE INHIBITOR; TRICYCLIC ANTIDEPRESSANT AGENT;

ANENCEPHALUS; BODY TEMPERATURE DISORDER; BONE MALFORMATION; CARDIOVASCULAR MALFORMATION; CLEFT LIP; CLEFT PALATE; CONGENITAL MALFORMATION; CONTROLLED STUDY; CONVULSION; DELIVERY; DEPRESSION; ENDOCRINE DISEASE; EYE MALFORMATION; FACE MALFORMATION; FETUS DEATH; FIRST TRIMESTER PREGNANCY; GASTROINTESTINAL MALFORMATION; GENITAL MALFORMATION; HEART SEPTUM DEFECT; HUMAN; HYPOGLYCEMIA; INFANT; MAJOR CLINICAL STUDY; MANAGED CARE ORGANIZATION; METABOLIC DISORDER; NECK MALFORMATION; NERVOUS SYSTEM MALFORMATION; PERINATAL DRUG EXPOSURE; PREGNANCY; PREMATURE LABOR; PRESCRIPTION; PRIORITY JOURNAL; RESPIRATORY DISTRESS SYNDROME; RESPIRATORY TRACT MALFORMATION; REVIEW; RISK ASSESSMENT; SECOND TRIMESTER PREGNANCY; SPINA BIFIDA; THIRD TRIMESTER PREGNANCY; URINARY TRACT MALFORMATION;

ABNORMALITIES, DRUG-INDUCED; ANTIDEPRESSIVE AGENTS; ANTIDEPRESSIVE AGENTS, TRICYCLIC; FEMALE; FETUS; HUMANS; OBSTETRIC LABOR, PREMATURE; PREGNANCY; RETROSPECTIVE STUDIES; RISK; SEROTONIN UPTAKE INHIBITORS;

EID: 35649000050     PISSN: 10538569     EISSN: 10991557     Source Type: Journal    
DOI: 10.1002/pds.1462     Document Type: Review

References (30)

1. Gaynes BN, Gavin N, Meltzen-Brody S, et al. Perinatal depression: prevalence, screening accuracy, and screening outcomes. Evid Rep Technol Assess (Summ) 2005; 119: 1-8.
2. Altshuler LL, Cohen LS, Moline ML, Kahn DA, Carpenter D, Docherty JP. Expert Consensus Panel for Depression in Women. The expert consensus guideline series. Treatment of depression in women. Postgrad Med 2001; 1-107.
3. Kalra S, Born L, Sarkar M, Einarson A. The safety of antidepressant use in pregnancy. Expert Opin Drug Saf 2005; 4 273-284.
4. Koren G. SSRIs in pregnancy - are they safe? Pediatr Res 2002; 51: 424-425.
5. Koren G, Matsui D, Einarson A, Knopper D, Meir S. Using antidepressants during pregnancy (letters). CMAJ 2005; 173: 1205-1206.
6. Andrade SE, Gurwitz JH, Davis RL, et al. Prescription drug use in pregnancy. Am J Obstet Gynecol 2004; 191: 398-407.
7. http://www.fda.gov/cder/drug/infopage/paroxetine/default.htm
8. http://ctr.gsk.co.uk/Summary/paroxetine/studylist.asp
9. Wogelius P, Norgaard M, Muff Munk E, et al. Maternal use of selective serotonin reuptake inhibitors and risk of adverse pregnancy outcomes. Pharmacoepidemiol Drug Saf 2005; 14: S143.
10. Einarson TR, Einarson A. Newer antidepressants in pregnancy and rates of major malformations: a meta-analysis of prospective comparative studies. Pharmacoepidemiol Drug Saf 2005; 14: 823-827.
11. 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.
12. Simon GE, Cunningham ML, Davis RL, et al. Outcomes of prenatal antidepressant exposure. Am J Psychiatry 2002; 159: 2055-2061.
13. Hendrick V, Smith LM, Suri R, et al. Birth outcomes after prenatal exposure to antidepressant medication. Am J Obstet Gynecol 2003; 188: 812-815.
14. Lattimore KA, Donn SM, Kaciroti N, et al. Selective serotonin reuptake inhibitor (SSRI) use during pregnancy and effects on the fetus and newborn: a meta-analysis. J Perinatol 2005; 25: 595-604.
15. Chambers CD, Hernandex-Diaz S, Van Marter LJ, et al. Selective serotonin-reuptake inhibitors and risk of persistent pulmonary hypertension of the newborn. N Engl J Med 2006; 354: 579-587.
16. Costei AM, Kozer E, Ho T, et al. Perinatal outcome following third trimester exposure to paroxetine. Arch Pediatr Adolesc Med 2002; 156: 1129-1132.
17. Jaiswal S, Coombs RC, Isbisten GK, et al. Paroxetine withdrawal in a neonate with historical and laboratory confirmation. Eur J Pediatr 2003; 162: 723-724.
18. Laine K, Heikkinen T, Ekblad U, et al. Effects of exposure to selective serotonin reuptake inhibitors during pregnancy on serotonergic symptoms in newborns and cord blood monoamine and prolactin concentrations. Arch Gen Psychiatry 2003; 60: 720-726.
19. Casper RC, Fleisher BE, Lee-Ancajas JC, et al. Follow-up of children of depressed mother exposed or not exposed to antidepressant drugs during pregnancy. J Pediatr 2003; 142: 402-408.
20. Sanz EJ, De-Las-Cuevas C, Kium A, et al. Selective serotonin reuptake inhibitors in pregnant women and neonatal withdrawal syndrome: a database analysis. Lancet 2005; 365: 482-487.
21. Moses-Kolko EL, Bogen D, Perel J, et al. Neonatal signs after late in utero exposure to serotonin reuptake inhibitors: literature review and implications for clinical applications. JAMA 2005; 293: 2372-2383.
22. Kallen B. Neonate characteristics after maternal use of antidepressants in late pregnancy. Arch Pediatr Adolesc Med 2004; 158: 312-316.
23. Goldstein DJ. Effects of third trimester fluoxetine exposure on the newborn. J Clin Psychopharmacol 1995; 15: 417-420.
24. Chambers CD, Johnson KA, Dick LM, Felix RJ, Lyons Jones K. Birth outcomes in pregnant women taking Fluoxetine. N Engl J Med 1996; 335: 1010-1015.
25. Zeskind PS, Stephens LE. Maternal selective serotonin reuptake inhibitor use during pregnancy and newborn neurobehavior. Pediatrics 2004; 113: 368-375.
26. Ericson A, Kallen B, Wiholm BE. Delivery outcome after the use of antidepressants in early pregnancy. Eur J Clin Pharmacol 1999; 55: 503-508.
27. Eberhard-Gran M, Eskild A, Opjordsmoen S. Treating mood disorders during pregnancy: safety considerations. Drug Saf 2005; 28: 695-706.
28. Prieto L, Martinez-Frias ML. Case-control studies using only malformed infants: are we interpreting the results correctly? Teratology 1999; 60: 1-2.
29. Hook EB. What kind of controls to use in case control studies of malformed infants: recall bias versus "teratogen nonspecificity" bias. Teratology 2000; 61: 325-326.
30. Raebel MA, Ellis JL, Andrade SE. Evaluation of gestational age and admission data assumptions used to determine prenatal drug exposure from administrative data. Pharmacopeidemiol Drug Saf 2005; 14(12): 829-836.