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U.S. Department of Health and Human Services

Safety

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Safyral (drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium) tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – February and April 2012

 

April 2012

Summary View

 

WARNINGS AND PRECAUTIONS

Thromboembolic Disorders and Other Vascular Problems
  • Based on presently available information on Yasmin, DRSP-containing COCs may be associated with a higher risk of venous thromboembolism (VTE) than COCs containing the progestin levonorgestrel or some other progestins…

 

PATIENT COUNSELING INFORMATION

  • Counsel patients about the information regarding the risk of VTE with DRSP-containing COCs compared to COCs that contain levonorgestrel or some other progestins.

 

February 2012

Summary View

 

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.

 

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