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New Interim Data About Combination Oral Contraceptives
Date:3/25/2011

sion to implement a pause in their COC routine."  

Following the submission of the interim analysis, Bayer worked with the US Food and Drug Administration (FDA) and updated the Prescribing Information for YAZ® (3 mg drospirenone / 0.02 mg ethinyl estradiol) in the US.  Bayer will continue to work with the FDA to update the Prescribing Information for all of its oral contraceptives in the US.

Like pregnancy, the use of COCs is associated with an increased risk of blood clots, which can be life-threatening. However, pregnancy increases the risk of blood clots as much or more than the use of COCs. These events are uncommon in healthy women using COCs.

Since 2001, Bayer commissioned independent investigators to conduct large-scale observational studies assessing the risk of VTE in women using COCs containing a variety of progestins, including drospirenone.  The results from these studies have been shared with the FDA and other regulatory authorities.

"Increased VTE risk is associated with any COC, and Bayer is committed to studying the safety and efficacy of our products.   Birth control pills are among the most systematically studied medicines available today," said Dr. Plouffe.

Several studies have investigated the relative risks of thromboembolism in women using drospirenone-containing COCs compared to women using COCs containing other progestins.

Bayer's post-marketing studies have shown that the risk of VTE in a COC formulation containing 3 mg drospirenone in combination with 0.03 mg ethinyl estradiol is comparable to that of any COCs in those studies.(1,2)

Two other published studies – one case-control study and one retrospective cohort study – have suggested that the risk of VTE occurring in drospirenone/ethinyl estradiol users was between the risk associated with levonorgestrel-containing COCs and desogestrel/gestodene-containing COCs.(3,4)  In April 2010, the FDA appro
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SOURCE Bayer HealthCare Pharmaceuticals Inc.
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