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Drospirenone-containing oral contraceptives and venous thromboembolism: an analysis of the FAERS database

Authors Madigan D, Shin J

Received 6 January 2018

Accepted for publication 3 February 2018

Published 11 April 2018 Volume 2018:9 Pages 29—32


Checked for plagiarism Yes

Review by Single-blind

Peer reviewer comments 2

Editor who approved publication: Professor Igal Wolman

David Madigan, Jennifer Shin

Department of Statistics, Columbia University, New York, NY, USA

Introduction: Substantial evidence suggests that drospirenone-containing oral contraceptives may cause a higher risk of venous thrombotic events than earlier-generation oral contraceptives.
Methods: To gain insight into recent real-world implications, we conducted an analysis using the US Food and Drug Administration’s Adverse Event Reporting System.
Results: Venous thrombotic events continue to be reported at a much higher rate with drospirenone-containing oral contraceptives than the general background. The disproportionality has been rising since 2010. The same behavior is not seen with levonorgestrel-containing oral contraceptives.
Conclusion: Our results are consistent with decreased physician and patient awareness of risks associated with drospirenone-containing oral contraceptives.

Keywords: drug safety, Yaz, venous thrombotic events, FDA adverse event reporting system, disproportionality

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