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

ved an update to the YAZ Prescribing Information regarding these two studies and indicated that they may be unreliable, specifically:

  • With regard to the case-control study, the Prescribing Information indicates that, "…the number of [3 mg drospirenone/0.03 mg ethinyl estradiol] cases was very small (1.2% of all cases) making the risk estimates unreliable."  
  • Concerning the retrospective cohort study, the Prescribing Information indicates that, "The relative risk for [3 mg drospirenone/0.03 mg ethinyl estradiol] users in the retrospective cohort study was greater than that for users of other COCs 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 one to four years, the relative risk was similar for users of [3 mg drospirenone/0.03 mg ethinyl estradiol] to that for users of other COC products."

Women should not use YAZ if they smoke and are over age 35.  Smoking increases the risk of serious side effects from the Pill, which can be life-threatening, including blood clots, stroke or heart attack.  This risk increases with age and number of cigarettes smoked.

YAZ increases the risk of serious conditions including blood clots, stroke, and heart attack. The risk of blood clots is highest during the first year of use.  

In addition, YAZ contains drospirenone, a different kind of hormone that for some may increase potassium too much. Therefore, women should not take YAZ if they have kidney, liver, or adrenal disease because this could cause serious heart and health problems.  Women who are on daily, long-term treatment for a chronic condition with medications that may also increase potassium (see below), should consult with their healthcare provider as they should have a blood tes
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SOURCE Bayer HealthCare Pharmaceuticals Inc.
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