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

David Madigan, Jennifer Shin

Substantial evidence suggests that drospirenone-containing oral contraceptives may cause a higher risk of venous thrombotic events than earlier-generation oral contraceptives. To gain insight into recent real-world implications, we conducted an analysis using the US Food and Drug Administration's Adverse Event Reporting System. 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. Our results are consistent with decreased physician and patient awareness of risks associated with drospirenone-containing oral contraceptives.