The FDA posted the results of its much anticipated large retrospective study about the risk of venous thrombotic events (VTEs) and newer contraceptives containing drosperinone (DRSP) such as Yasmin, Yaz and Beyaz.
The FDA reports “In adjusted analyses, DRSP was associated with a significantly higher risk of VTE (venous thrombotic events) relative to low-estrogen comparators such as levonorgestrol with estimates of relative risk of 1.74 (95% CI 1.42 – 2.14)”.
The FDA acknowledged that the majority of previous epidemiological studies (4 of 6), all conducted retrospectively, demonstrate an increased risk of VTE with the use of DRSP-containing contraceptives suggesting that this association may be real.
According to the FDA, this study “provides another positive finding to the increasing body of evidence linking DRSP to increased risk of VTE” when compared to standard birth control pills.
With these results and the other “positive findings”, what will the FDA do? That discussion has been reserved for the FDA meeting on December 8, 2011.