Label Changes for:
Safyral (drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium) tablets
February 2012
Changes have been made to the WARNINGS and PRECAUTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – February 2012
WARNINGS AND PRECAUTIONS
Thromboembolic Disorders and Other Vascular Problems
- Data from a large, prospective cohort safety study of various COCs suggest that this increased risk, as compared to that in non-COC users, is greatest during the first 6 months of COC use. Data from this safety study indicate that the greatest risk of VTE is present after initially starting a COC or restarting (following a 4 week or greater pill-free interval) the same or a different COC.
