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