Use of selective serotonin reuptake inhibitors (SSRIs) in women delivering liveborn infants and other women of child-bearing age within the U.S. Food and Drug Administration’s Mini-Sentinel program
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This study was conducted in order to assess the prevalence of use of selective serotonin reuptake inhibitors (SSRIs) among pregnant women delivering a liveborn infant in the USA. A retrospective study was conducted using the automated databases of 15 health-care systems participating in the Mini-Sentinel program. Diagnosis and procedure codes were used to identify women ages 10 to 54 years delivering a liveborn infant between April 2001 and December 2013. A comparison group of age- and date-matched women without live births was identified. The frequency of use of SSRIs was identified from outpatient dispensing data. Among the 1,895,519 liveborn deliveries, 113,689 women (6.0 %) were exposed to an SSRI during pregnancy during the period 2001–2013; 5.4 % were exposed to an SSRI during 2013. During the corresponding time period, 10.5 % of the age- and date-matched cohort of women without live births was exposed to an SSRI, with 10.1 % exposed to an SSRI during 2013. The most common agents dispensed during pregnancy were sertraline (n = 48,678), fluoxetine (n = 28,983), and citalopram (n = 20,591). Among those women exposed to an SSRI during pregnancy, 53.8 % had a diagnosis of depression and 37.3 % had a diagnosis of an anxiety disorder during pregnancy or within 180 days prior to pregnancy. Our finding that 6 % of women with live births were prescribed SSRIs during pregnancy highlights the importance of understanding the differential effects of these medications and other therapeutic options on the developing fetus and on the pregnant women.
KeywordsPregnancy Selective serotonin reuptake inhibitors Prevalence
The authors would like to thank Statlog Consulting, Inc. for their programming support. We would also like to thank the 15 Data Partners that participated in this study: Aetna (Cheryl McMahill-Walraven, PhD, MSW [Site PI]; Yihai Liu, MS [Analyst]); Group Health Research Institute (Denise Boudreau, PhD, RPh [Site PI]; Tyler Ross, MA [Analyst]); Harvard Pilgrim Health Care (Jeffrey Brown, PhD [Site PI]; Yury Vilk, PhD [Analyst]); HealthCore, Inc. (Nandini Selvam, PhD, MPH [Site PI]; Fang Tian, PhD, MPH [Analyst]); HealthPartners Institute for Education and Research (Pamala Pawloski, PharmD [Site PI]; Terese DeFor, MS [Analyst]); Humana (Vinit Nair, BPharm, MS, RPh [Site PI]; Mano Selvan, PhD; Yihua Xu, PhD; Qianli Ma, MS [Analyst]); Kaiser Permanente Colorado (Marsha A. Raebel, PharmD [Site PI]; Carsie A. Nyirenda, MPH [Analyst]); Kaiser Permanente Hawaii (Connie Trinacty, PhD [Site PI]; John V. Parker, BS [Analyst]); Kaiser Permanente Mid-Atlantic (Michael Horberg, MD, MAS, FACP, FIDSA [Site PI]; Alphonse Derus, MS [Analyst]); Kaiser Permanente Northern California (Lisa Herrinton, PhD [Site PI]; Jack Hamilton, AB [Analyst]); Kaiser Permanente Northwest (David H. Smith, RPh, PhD [Site PI]; Amanda F. Petrik, MS [Analyst]); Marshfield Clinic (Robert Greenlee, PhD, MPH [Site PI]; Valerie McManus, MPH [Analyst]); Meyers Primary Care Institute (Hassan Fouayzi, MS [Analyst]); OptumInsight, Inc. (Nancy Lin, ScD [Site PI]; Eva Ng, MS [Analyst]); and Vanderbilt University Medical Center (Marie Griffin, MD, MPH [Site PI]; James Morrow, BS [Analyst]). We are indebted to the Tennesee Bureau of TennCare of the Department of Finance and Administration which provided data.
Compliance with ethical standards
Conflict of interest
The authors declare that they have no conflict of interest.
Source of funding
This study was supported through funding from contract HHSF223200910006I, Task Order # HHSF22301007T and Task Order # HHSF22301016T from the U.S. Food and Drug Administration (FDA). Co-authors from the FDA provided input on the study design and analysis plan, and participated in the interpretation of the results and in the preparation and decision to submit the manuscript for publication. The FDA reviewed and approved this manuscript. The FDA had no role in data collection or management.
The views expressed in this paper are those of the authors and are not intended to convey official U.S. Food and Drug Administration (FDA) policy or guidance.
- Kawai AT, Li L, Kulldorff M, et al. (2014) Mini-Sentinel CBER/PRISM surveillance protocol influenza vaccines and pregnancy outcome. Version 2. http://www.mini-sentinel.org/work_products/PRISM/Mini-Sentinel_PRISM_Influenza-Vaccines-and-Pregnancy-Outcomes-Protocol.pdf. Accessed 8 Sept 2015
- Rosati K, Evans B, McGraw D (2011) HIPAA and common rule compliance in the Mini-Sentinel pilot, white paper. http://www.mini-sentinel.org/work_products/About_Us/HIPAA_and_CommonRuleCompliance_in_the_Mini-SentinelPilot.pdf [serial online]. Accessed 8 Sept 2015
- U.S. Food and Drug Administration (2004) FDA Medwatch drug alert on Effexor and SSRIs. June 3, 2004. Effexor and Effexor XR (venlafaxine HCl) http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm154975.htm. Accessed 8 Sept 2015
- U.S. Food and Drug Administration (2005) FDA public health advisory: paroxetine. December 8, 2005. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm051731.htm. Accessed 8 Sept 2015
- U.S. Food and Drug Administration (2006) FDA alert [7/2006]: increased risk of neonatal persistent pulmonary hypertension. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm085313.htm. Accessed 8 Sept 2015
- U.S. Food and Drug Administration (2011) FDA drug safety communication: selective serotonin reuptake inhibitor (SSRI) antidepressant use during pregnancy and reports of a rare heart and lung condition in newborn babies. December 14, 2011. http://www.fda.gov/Drugs/DrugSafety/ucm283375.htm. Accessed 8 Sept 2015
- Yonkers KA, Wisner KL, Stewart DE, Oberlander TF, Dell DL, Stotland N, Ramin S, Chaudron L, Lockwood C (2009) The management of depression during pregnancy: a report from the American Psychiatric Association and the American College of Obstetricians and Gynecologists. Obstet Gynecol 114:703–713CrossRefPubMedPubMedCentralGoogle Scholar