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Open Access J Contracept. 2018 Apr 11;9:29-32. doi: 10.2147/OAJC.S161737. eCollection 2018.

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

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1
Department of Statistics, Columbia University, New York, NY, USA.

Abstract

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:

FDA adverse event reporting system; Yaz; disproportionality; drug safety; venous thrombotic events

Conflict of interest statement

Disclosure Dr Madigan testified for plaintiffs in litigation related to Yaz in 2011. The authors report no other conflicts of interest in this work.

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