Reproductive safety of second-generation antipsychotics: Current data from the Massachusetts general hospital national pregnancy registry for atypical antipsychotics

American Journal of Psychiatry

Volumn 173, Issue 3, 2016, Pages 263-270

  Cohen, Lee S ^a   Viguera, Adele C ^a   McInerney, Kathryn A ^a   Freeman, Marlene P ^a   Sosinsky, Alexandra Z ^a   Moustafa, Danna ^a   Marfurt, Samantha P ^a   Kwiatkowski, Molly A ^a   Murphy, Shannon K ^a   Farrell, Adriann M ^a   Chitayat, David ^a   Hernández Díaz, Sonia ^a  

^a UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTICONVULSIVE AGENT; ANXIOLYTIC AGENT; CENTRAL STIMULANT AGENT; LITHIUM SALT; NEUROLEPTIC AGENT; SEDATIVE AGENT; SEROTONIN NORADRENALIN REUPTAKE INHIBITOR; SEROTONIN UPTAKE INHIBITOR; TRICYCLIC ANTIDEPRESSANT AGENT;

ADULT; ARTICLE; CONGENITAL MALFORMATION; CONTROLLED STUDY; DATA ANALYSIS; DATA BASE; DELIVERY; DRUG SAFETY; FEMALE; FOLLOW UP; GENERAL HOSPITAL; HUMAN; LABOR; LIVE BIRTH; MAJOR CLINICAL STUDY; MEDICAL RECORD REVIEW; MENTAL DISEASE; PREGNANCY; PRENATAL DRUG EXPOSURE; PRIORITY JOURNAL; PROSPECTIVE STUDY; PUERPERIUM; REGISTRATION; REPRODUCTIVE TOXICITY; RISK ASSESSMENT; RISK BENEFIT ANALYSIS; ABNORMALITIES, DRUG-INDUCED; CLASSIFICATION; CLINICAL TRIAL; DRUG EFFECTS; MASSACHUSETTS; MENTAL DISORDERS; OUTCOME ASSESSMENT; PREGNANCY OUTCOME; PRENATAL EXPOSURE; REGISTER; STATISTICS AND NUMERICAL DATA;

ABNORMALITIES, DRUG-INDUCED; ADULT; ANTIPSYCHOTIC AGENTS; FEMALE; HUMANS; MASSACHUSETTS; MENTAL DISORDERS; OUTCOME ASSESSMENT (HEALTH CARE); PREGNANCY; PREGNANCY OUTCOME; PREGNANCY TRIMESTERS; PRENATAL EXPOSURE DELAYED EFFECTS; REGISTRIES;

EID: 84959458421     PISSN: 0002953X     EISSN: 15357228     Source Type: Journal    
DOI: 10.1176/appi.ajp.2015.15040506     Document Type: Article

References (40)

1. Camsari U, Viguera AC, Ralston L, et al: Prevalence of atypical antipsychotic use in psychiatric outpatients: comparison of women of childbearing age with men. Arch Women Ment Health 2014;17:583-586
2. Toh S, Li Q, Cheetham TC, et al: Prevalence and trends in the use of antipsychotic medications during pregnancy in the U. S., 2001-2007: a population-based study of 585, 615 deliveries. Arch Women Ment Health 2013;16:149-157
3. Alexander GC, Gallagher SA, Mascola A, et al: Increasing off-label use of antipsychotic medications in the United States, 1995-2008. Pharmacoepidemiol Drug Saf 2011;20:177-184
4. Abel KM: Fetal antipsychotic exposure in a changing landscape: seeing the future. Br J Psychiatry 2013;202:321-323
5. Coppola D, Russo LJ, Kwarta RF Jr, et al: Evaluating the postmarketing experience of risperidone use during pregnancy: pregnancy and neonatal outcomes. Drug Saf 2007;30:247-264
6. Einarson A, Boskovic R: Use and safety of antipsychotic drugs during pregnancy. J Psychiatr Pract 2009;15:183-192
7. Ernst CL, Goldberg JF: The reproductive safety profile of mood stabilizers, atypical antipsychotics, and broad-spectrum psychotropics. J Clin Psychiatry 2002;63(Suppl 4):42-55
8. Gentile S: Clinical utilization of atypical antipsychotics in pregnancy and lactation. Ann Pharmacother 2004;38:1265-1271
9. Goldstein DJCL, Corbin LA, Fung MC: Olanzapine-exposed pregnancies and lactation: early experience. J Clin Psychopharmacol 2000;20:399-403
10. Habermann F, Fritzsche J, Fuhlbrück F, et al: Atypical antipsychotic drugs and pregnancy outcome: a prospective, cohort study. J Clin Psychopharmacol 2013;33:453-462
11. McKenna K, Koren G, Tetelbaum M, et al: Pregnancy outcome of women using atypical antipsychotic drugs: a prospective comparative study. J Clin Psychiatry 2005;66:444-449
12. Reis M, Källén B: Maternal use of antipsychotics in early pregnancy and delivery outcome. J Clin Psychopharmacol 2008;28:279-288
13. Sadowski A, Todorow M, Yazdani Brojeni P, et al: Pregnancy outcomes following maternal exposure to second-generation antipsychotics given with other psychotropic drugs: a cohort study. BMJ Open 2013;3:e003062
14. Yaeger D, Smith HG, Altshuler LL: Atypical antipsychotics in the treatment of schizophrenia during pregnancy and the postpartum. Am J Psychiatry 2006;163:2064-2070
15. Ennis ZN, Damkier P: Pregnancyexposure to olanzapine, quetiapine, risperidone, aripiprazole and risk of congenital malformations. A systematic review. Basic Clin Pharmacol Toxicol 2015;116:315-320
16. Holmes LB, Wyszynski DF, Lieberman E: The AED (antiepileptic drug) pregnancy registry: a 6-year experience. Arch Neurol 2004;61:673-678
17. Kulkarni J, Worsley R, Gilbert H, et al: A prospective cohort study of antipsychotic medications in pregnancy: the first 147 pregnancies and 100 one year old babies. PLoS One 2014;9:e94788
18. Tomson T, Battino D, Craig J, et al: Pregnancy registries: differences, similarities, and possible harmonization. Epilepsia 2010;51:909-915
19. Cole JA, Modell JG, Haight BR, et al: Bupropionin pregnancyand the prevalence of congenital malformations. Pharmacoepidemiol Drug Saf 2007;16:474-484
20. Chambers CD, Johnson KA, Dick LM, et al: Birth outcomes in pregnantwomen taking fluoxetine. N Engl J Med 1996;335:1010-1015
21. Schou M, Amdisen A, Steenstrup OR: Lithium and pregnancy. II. Hazards to women given lithium during pregnancy and delivery. BMJ 1973;2:137-138
22. Kulkarni J, McCauley-Elsom K, Marston N, et al: Preliminary findings from the National Register of Antipsychotic Medication in Pregnancy. Aust N Z J Psychiatry 2008;42:38-44
23. Holmes LB, Wyszynski DF: North American antiepileptic drug pregnancy registry. Epilepsia 2004;45:1465
24. Cohen LS, Viguera AC, McInerney KA, et al: Establishment of the National Pregnancy Registry for Atypical Antipsychotics. J Clin Psychiatry 2015;76:986-989
25. Cohen LS, Viguera AC, Masnik S, et al: The National Pregnancy Registry for Atypical Antipsychotics: Effects of Fetal Exposure on Risk for Major Malformations, in 53rd Annual Meeting of the Teratology Society. Tucson, Ariz, Jun. 22-26, 2013
26. Cohen LS, Viguera AC, McInerney KA, et al: The National Pregnancy Registry for Atypical Antipsychotics: Effects of Fetal Exposure on Risk for Major Malformations and Extrapyramidal Symptoms, in American College of Neuropsychopharmacology 53rd Annual Meeting. Phoenix, Dec. 7-11, 2014
27. Holmes LB: Need for inclusion and exclusion criteria for the structural abnormalities recorded in children born from exposed pregnancies. Teratology 1999;59:1-2
28. Food and Drug Administration, HHS: Content and format of labeling for human prescription drug and biological products; requirements for pregnancy and lactation labeling. Final rule. Fed Regist 2014;79:72063-72103
29. McBride WG: Thalidomide and congenital abnormalities. Lancet 1961;2:1358
30. Wyszynski DF, Nambisan M, Surve T, et al: Increased rate of major malformations in offspring exposed to valproate during pregnancy. Neurology 2005;64:961-965
31. Hoyert DL, Mathews TJ, Menacker F, et al: Annual summary of vital statistics: 2004. Pediatrics 2006;117:168-183
32. Werler MM, Louik C, Shapiro S, et al: Prepregnantweight in relation to risk of neural tube defects. JAMA 1996;275:1089-1092
33. Werler MM, Shapiro S, Mitchell AA: Periconceptional folic acid exposure and risk of occurrent neural tube defects. JAMA 1993;269:1257-1261
34. Shiono PH, Klebanoff MA, Berendes HW: Congenital malformations and maternal smoking during pregnancy. Teratology 1986;34:65-71
35. Naeye RL: Maternal age, obstetric complications, and the outcome of pregnancy. Obstet Gynecol 1983;61:210-216
36. Clarren SK, Smith DW: The fetal alcohol syndrome. N Engl J Med 1978;298:1063-1067
37. Huybrechts KF, Palmsten K, Avorn J, et al: Antidepressant use in pregnancy and the risk of cardiac defects. N Engl J Med 2014;370:2397-2407
38. Viguera AC, Whitfield T, Baldessarini RJ, et al: Risk of recurrence in womenwith bipolar disorder during pregnancy: prospective study of mood stabilizer discontinuation. Am J Psychiatry 2007;164:1817-1824
39. 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
40. Harden CL, Meador KJ, Pennell PB, et al: Practice parameter update: management issues for women with epilepsy-focus on pregnancy (an evidence-based review): teratogenesis and perinatal outcomes: report of the Quality Standards Subcommittee and Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology and American Epilepsy Society. Neurology 2009;73:133-141