Label Changes for:

Yasmin (drospirenone/ethinyl estradiol) tablets

February 2012

Changes have been made to the WARNINGS, PRECAUTIONS and PATIENT PACKAGE INSERT sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – April 2010 and February 2012

 

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.

 

PATIENT COUNSELING INFORMATION

See “FDA-approved patient labeling (Patient Information).”
  • Counsel patients that cigarette smoking increases the risk of serious cardiovascular events from COC use, and that women who are over 35 years old and smoke should not use COCs.
  • Counsel patients that the increased risk of VTE compared to non-users of COCs is greatest after initially starting a COC or restarting (following a 4-week or greater pill-free interval) the same or a different COC…

 

April 2010

 

WARNINGS

Thromboembolic Disorders and Other Vascular Problems

Thromboembolism

  • Several studies have investigated the relative risks of thromboembolism in women using Yasmin compared to those in women using COCs containing other progestins. Two prospective cohort studies, both evaluating the risk of venous and arterial thromboembolism and death, were initiated at the time of Yasmin  approval. The first (EURAS) showed the risk of thromboembolism (particularly venous thromboembolism) and death in Yasmin users to be comparable to that of other oral contraceptive preparations, including those containing levonorgestrel (a so-called second generation COC). The second prospective cohort study (Ingenix) also showed a comparable risk of thromboembolism in Yasmin users compared to users of other COCs, including those containing levonorgestrel. In the second study, COC comparator groups were selected based on their having similar characteristics to those being prescribed Yasmin.
  • Two additional epidemiological studies, one case-control study (van Hylckama Vlieg et al. 3) and one retrospective cohort study (Lidegaard et al. 4) suggested that the risk of venous thromboembolism occurring in Yasmin users was higher than that for users of levonorgestrelcontaining COCs and lower than that for users of desogestrel/gestodene-containing COCs (socalled third generation COCs). In the case-control study, however, the number of Yasmin cases was very small (1.2% of all cases) making the risk estimates unreliable. The relative risk for Yasmin users in the retrospective cohort study was greater than that for users of other COC products when considering women who used the products for less than one year. However, these one-year estimates may not be reliable because the analysis may include women of varying risk levels. Among women who used the product for 1 to 4 years, the relative risk was similar for users of Yasmin to that for users of other COC products.

 

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