Duloxetine and pregnancy outcomes: Safety surveillance findings

International Journal of Medical Sciences

Volumn 10, Issue 4, 2013, Pages 413-419

  Hoog, Sharon L ^a   Cheng, Yingkai ^a   Elpers, John ^a   Dowsett, Sherie A ^a  

^a ELI LILLY AND COMPANY   (United States)

Author keywords

Antidepressants; Birth defects; Duloxetine; Pregnancy outcomes; Safety surveillance

Indexed keywords

AMFEBUTAMONE; AMITRIPTYLINE; ANTICONVULSIVE AGENT; ANTIDEPRESSANT AGENT; BENZODIAZEPINE DERIVATIVE; CITALOPRAM; DESVENLAFAXINE; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; DOXEPIN; DULOXETINE; ESCITALOPRAM; FLUOXETINE; IMIPRAMINE; NEFAZODONE; NONSTEROID ANTIINFLAMMATORY AGENT; PAROXETINE; SERTRALINE; VENLAFAXINE;

ADULT; ARTICLE; CONGENITAL MALFORMATION; CONTROLLED STUDY; DEPRESSION; DRUG EXPOSURE; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; ECTOPIC PREGNANCY; FEMALE; HUMAN; MAJOR CLINICAL STUDY; NEWBORN DISEASE; POSTMARKETING SURVEILLANCE; PREGNANCY OUTCOME; PREMATURITY; PROSPECTIVE STUDY; SPONTANEOUS ABORTION; STILLBIRTH;

ANTIDEPRESSANTS; BIRTH DEFECTS; DULOXETINE.; PREGNANCY OUTCOMES; SAFETY SURVEILLANCE;

ABORTION, SPONTANEOUS; ADULT; ADVERSE DRUG REACTION REPORTING SYSTEMS; ANTIDEPRESSIVE AGENTS; DEPRESSIVE DISORDER, MAJOR; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; FEMALE; HUMANS; INFANT; INFANT, NEWBORN; PREGNANCY; PREGNANCY COMPLICATIONS; PREGNANCY OUTCOME; THIOPHENES; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84874761425     PISSN: 14491907     EISSN: None     Source Type: Journal    
DOI: 10.7150/ijms.5213     Document Type: Article

References (23)

1. Kessler RC, Berglund P, Demler O, et al; National Comorbidity Survey Replication. The epidemiology of major depressive disorder: results from the National Comorbidity Survey Replication (NCS-R). JAMA. 2003; 289: 3095-105.
2. Kessler RC, McGonagle KA, Swartz M, et al. Sex and depression in the National Comorbidity Survey. I: Lifetime prevalence, chronicity and recurrence. J Affect Disord. 1993; 29: 85-96.
3. Bennett HA, Einarson A, Taddio A, et al. Prevalence of depression during pregnancy: systematic review. Obstet Gynecol 2004; 103: 698-709.
4. Cooper WO, Willy ME, Pont SJ, et al. Increasing use of antidepressants in pregnancy. Am J Obstet Gynecol. 2007; 196: 544.e1-5.
5. Woo EJ, Ball R, Burwen DR, Braun MM. Effects of stratification on data mining in the US Vaccine Adverse Event Reporting System (VAERS). Drug Saf. 2008; 31:667-74.
6. Papay J, Yuen N, Powell G, et al. Spontaneous adverse event reports of Stevens-Johnson syndrome/toxic epidermal necrolysis: detecting associations with medications. Pharmacoepidemiol Drug Saf. 2012; 21:289-96.
7. Simpson JL. Incidence and timing of pregnancy losses: relevance to evaluating safety of early prenatal diagnosis. Am J Med Genet. 1990; 35: 165-73.
8. Martin JA, Hamilton BE, Ventura SJ, et al. Births: Final Data for 2009. Washington, DC, US Department of Health and Human Services, Centers for Disease Control and Prevention, National Vital Statistics Reports 2011; 60: 1. http://www.cdc.gov/nchs/data/nvsr/nvsr60/nvsr60_01.pdf.
9. Correa A, Cragan J, Kucik J, et al. Metropolitan Atlanta Congenital Defects Program 40th Anniversary Edition Surveillance Report: Reporting Birth Defects Surveillance Data 1968-2003. Birth Defects Research Part A: Clinical and Molecular Teratology. 2007; 79 (2): 65-93.
10. US Department of Health and Human Services, Centers for Disease Control and Prevention. Current Trends Ectopic Pregnancy - United States, 1990-1992. MMWR 1995; 44 (03): 46-48. http://www.cdc.gov/mmwr/preview/mmwrhtml/00035709.htm
11. Van Den Eeden SK, Shan J, Bruce C, et al. Ectopic pregnancy rate and treatment utilization in a large managed care organization. Obstet Gynecol. 2005; 105: 1052-7.
12. Macdorman MF, Kirmeyer, S.Fetal and Perinatal Mortality, United States, 2005. Washington, DC, US Department of Health and Human Services, Centers for Disease Control and Prevention, National Vital Statistics Reports. 2009; 57: 8. http://www.cdc.gov/nchs/data/nvsr/nvsr57/nvsr57_08.pdf.
13. Poluzzi E, Raschi E, Motola D, et al. Antimicrobials and the risk of torsades de pointes: the contribution from data mining of the US FDA Adverse Event Reporting System. Drug Saf. 2010; 33: 303-14.
14. DuMouchel W, Fram D, Yang X, et al. Antipsychotics, glycemic disorders, and life-threatening diabetic events: a Bayesian data-mining analysis of the FDA adverse event reporting system (1968-2004). Ann Clin Psychiatry. 2008;20: 21-31.
15. Yonkers KA, Wisner KL, Stewart DE, et al. The management of depression during pregnancy: a report from the American Psychiatric Associa tion and the American College of Obstetricians and Gynecologists. Obstet Gynecol. 2009; 114: 703-13.
16. 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.
17. Yonkers KA, Gotman N, Smith MV, et al. Does antidepressant use attenuate the risk of a major depressive episode in pregnancy? Epidemiology. 2011; 22: 848-54.
18. Zuckerman B, Bauchner H, Parker S, Cabral H. Maternal depressive symptoms during pregnancy, and newborn irritability. J Dev Behav Pediatr 1990;11:190-194.
19. Riley AW, Coiro MJ, Broitman M et al. Mental Health of Children of Low-Income Depressed Mothers: Influences of Parenting, Family Environment, and Raters. Psychiatric Services 2009;60:329-336.
20. Klimes-Dougan B, Free K, Ronsaville D, et al. Suicidal ideation and attempts: a longitudinal investigation of children of depressed and well mothers. J Am Acad Child Adolesc Psychiatry. 1999;38:651-659.
21. Bar-Oz B, Einarson T, Einarson A, et al. Paroxetine and congenital malformations: meta-Analysis and consideration of potential confounding factors. Clin Ther. 2007; 29: 918-926.
22. US Department of Health and Human Services, US Food and Drug Administration. MedWatch: The FDA Safety Information and Adverse Event Reporting Program. http://www.fda.gov/Safety/MedWatch/default.htm
23. [Internet] Eli Lilly and Company. Cymbalta® (duloxetine HCl capsules); The Cymbalta® Pregnancy Registry [online]. http://cymbaltapregnancyregistry.com/.