Drospirenone-containing oral contraceptives and venous thromboembolism: an analysis of the FAERS database
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...
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| Format: | Article |
| Language: | English |
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Dove Medical Press
2018-04-01
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| Series: | Open Access Journal of Contraception |
| Subjects: | |
| Online Access: | https://www.dovepress.com/drospirenone-containing-oral-contraceptives-and-venous-thromboembolism-peer-reviewed-article-OAJC |
| _version_ | 1819130426195705856 |
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| author | Madigan D Shin J |
| author_facet | Madigan D Shin J |
| author_sort | Madigan D |
| collection | DOAJ |
| description | 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 |
| first_indexed | 2024-12-22T08:59:25Z |
| format | Article |
| id | doaj.art-422f035892a54604a2b50c4e81f662f0 |
| institution | Directory Open Access Journal |
| issn | 1179-1527 |
| language | English |
| last_indexed | 2024-12-22T08:59:25Z |
| publishDate | 2018-04-01 |
| publisher | Dove Medical Press |
| record_format | Article |
| series | Open Access Journal of Contraception |
| spelling | doaj.art-422f035892a54604a2b50c4e81f662f02022-12-21T18:31:45ZengDove Medical PressOpen Access Journal of Contraception1179-15272018-04-01Volume 9293237712Drospirenone-containing oral contraceptives and venous thromboembolism: an analysis of the FAERS databaseMadigan DShin JDavid 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, disproportionalityhttps://www.dovepress.com/drospirenone-containing-oral-contraceptives-and-venous-thromboembolism-peer-reviewed-article-OAJCDrug safetyYazVenous thrombotic eventsFDA Adverse Event Reporting SystemDisproportionality |
| spellingShingle | Madigan D Shin J Drospirenone-containing oral contraceptives and venous thromboembolism: an analysis of the FAERS database Open Access Journal of Contraception Drug safety Yaz Venous thrombotic events FDA Adverse Event Reporting System Disproportionality |
| title | Drospirenone-containing oral contraceptives and venous thromboembolism: an analysis of the FAERS database |
| title_full | Drospirenone-containing oral contraceptives and venous thromboembolism: an analysis of the FAERS database |
| title_fullStr | Drospirenone-containing oral contraceptives and venous thromboembolism: an analysis of the FAERS database |
| title_full_unstemmed | Drospirenone-containing oral contraceptives and venous thromboembolism: an analysis of the FAERS database |
| title_short | Drospirenone-containing oral contraceptives and venous thromboembolism: an analysis of the FAERS database |
| title_sort | drospirenone containing oral contraceptives and venous thromboembolism an analysis of the faers database |
| topic | Drug safety Yaz Venous thrombotic events FDA Adverse Event Reporting System Disproportionality |
| url | https://www.dovepress.com/drospirenone-containing-oral-contraceptives-and-venous-thromboembolism-peer-reviewed-article-OAJC |
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