Continuous or Extended Cycle Oral Contraceptives & Venous Thromboembolism (VTE)

Basic Details
Status
Complete
Last Updated
Monday, March 5, 2018
Health Outcome(s)
venous thromboembolism (VTE)
Purpose
Drug and Outcome Analysis
Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
No
Regulatory Determination / Use

FDA decided that no action is necessary at this time, based on available information.

Analytic Code Link(s) (1)
Venous Thromboembolism Following Continuous or Extended Cycle Contraceptive Use: A Propensity Score Matched Analysis
Result(s) (2)
Combined Oral Contraceptives Containing Ethinyl Estradiol and Levonorgestrel and Venous Thromboembolism Venous Thromboembolism Following Continuous or Extended Cycle Contraceptive Use: A Propensity Score Matched Analysis
Related Publication(s) and/or Presentation(s) (2)
Presentation: Integrating Sentinel into Routine Regulatory Drug Review: A Snapshot of the First Year Publication: Association of Risk for Venous Thromboembolism With Use of Low-Dose Extended- and Continuous-Cycle Combined Oral Contraceptives: A Safety Study Using the Sentinel Distributed Database