Pharmacokinetics of Quetiapine Across Pregnancy and Postpartum
Status:
Active, not recruiting
Trial end date:
2020-12-01
Target enrollment:
Participant gender:
Summary
The widespread and common use of quetiapine in childbearing and pregnant women demands more
data to inform dosing and toxicity in pregnancy. The new FDA Pregnancy and Lactation Labeling
Final Rule (PLLR) will go into effect on June 30th, 2015 and will replace the prior A, B, C,
D, and X categories. Additionally, the PLLR will require information to aid prescribing
decisions in three categories 1) Pregnancy (including labor and delivery), 2) Lactation, and
3) Females and Males of Reproductive Potential. The pregnancy category will include a
subsection that will describe pharmacokinetic and pharmacodynamic characteristics of the
medication in pregnancy, fetal risk, and data quality. The data collected in this study will
update the FDA pregnancy pharmacokinetic section for quetiapine and inform physicians that
prescribe to childbearing women.