Thromboembolic events associated with combined oral contraceptives: a real-world study based on the FDA adverse event reporting system (FAERS) database.

BACKGROUND

The clinical characteristics and time-to-onset of thromboembolic events (TEEs) associated with combined oral contraceptives (COCs) remain unclear, our current study was committed to providing more data for risk evaluation and management of COCs treatment.

RESEARCH DESIGN AND

METHODS

This pharmacovigilance study was conducted in the FAERS database. We evaluated significant pharmacovigilance signals by using disproportionality analysis. The Weibull shape parameter test was used to analyze the time-to-onset of TEEs.

RESULTS

A total of 25,080 adverse events were involved in this study. Overall COCs were significantly related to venous thromboembolism (VTE) events. Levonorgestrel, desogestrel, and drospirenone containing COCs were significantly associated with arterial thromboembolism (ATE) besides norethisterone containing COCs. Drospirenone containing COCs associated with TEEs had the highest reporting frequencies (n = 22868, 91.18%). The most-mentioned PT was pulmonary embolism (n = 9244, 36.86%). The median time-to-onset of all TEEs was 264 days, the median time-to-onset of VTE was 258.0 days, shorter than ATE (344.0 days). The Weibull shape parameter test results showed that all of the disproportionality signals had early failure-type features.

CONCLUSIONS

This study found an increased risk of TEEs treated with COCs, particularly with drospirenone. We should pay close attention to risk monitor on the treatment of early stages.