Drug Use Among Pregnant Women with Live Births

Basic Details
Date Posted
Friday, January 29, 2016
Status
Complete
Medical Product
angiotensin-converting enzyme (ACE) inhibitor
anticonvulsant
dabigatran
lisinopril
methotrexate
mycophenolate mofetil
paroxetine
ribavirin
selective serotonin reuptake inhibitor (SSRI)
simvastatin
sodium valproate
statin
valproic acid
warfarin
Description

Development of analytic code to identify pregnant females based on diagnosis and procedure codes indicating a live birth in the Mini-Sentinel Distributed Database (MSDD), and assessment of prevalence of use of specific medications among these women.  A comparison group of age- and date-matched non-pregnant females is also identified.  Analytic code can be re-used by FDA to assess the use of medications during pregnancy.  Specifically, the code is readily adaptable to include different lists of medications for assessment, different time periods/calendar years for assessment, different age ranges of females, different lists of diagnosis and procedure codes to identify deliveries, to allow varying enrollment criteria.  The analytic code also allows the capacity to assess pre-existing conditions (diagnoses) and medications used before pregnancy, and restrict the population according to the presence or absence of these characteristics.

The cohorts of interest are females ages 10 to 54 delivering a liveborn infant, and age- and date-matched non-pregnant females.

Additional Details
FDA Center
CDER
Time Period
2001 - 2012
Study Type
Summary Table
Assessment Type
Exploratory Analyses
Population / Cohort
All females 10 to 54 years of age
Data Sources
Mini-Sentinel Distributed Database (MSDD)
Workgroup Leader(s)

Susan Andrade ScD; Meyers Primary Care Institute, Worcester MA

Darren Toh ScD; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

Workgroup Members

Noelle Cocoros DSc, MPH; Alison Kawai ScD; Katie Haffenreffer BS; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston MA

Marsha Reichman PhD; Marilyn Pitts PharmD; Monika Houstoun PharmD, MPH; Katrina Mott MHS; Caren Kieswetter MD, MPH; Carrie Ceresa PharmD, MPH; Miriam Dinatale DO; Center for Drug Evaluation and Research, FDA, Silver Spring, MD