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U.S. FDA Approves Second Bayer Oral Contraceptive That Also Raises Folate Levels
Date:12/16/2010

adrenal disease because this could cause serious heart and health problems, or if they have or have had blood clots, certain cancers, history of heart attack or stroke, or if they are or may be pregnant.  SAFYRAL increases the risk of serious conditions including blood clots, stroke and heart attack.  Smoking increases these risks, especially in women over 35.  The risk of blood clots is highest during the first year of use.  

In addition, SAFYRAL contains drospirenone, a different kind of hormone that for some may increase potassium too much.  Women should consult with their healthcare provider if they are on daily long-term treatment for a chronic condition with medications that may also increase potassium, as they should have a blood test to check their potassium level during the first month of taking SAFYRAL.

About the Clinical Development Program for SAFYRAL

The FDA approval of SAFYRAL to raise folate levels in women who choose an OC for contraception is based on two clinical trials. The first trial was a pivotal 24-week clinical trial involving 379 healthy women aged 18-40 years, which found that YAZ® (drospirenone 3 mg/ ethinyl estradiol 20 mcg) in combination with 451 mcg of Metafolin increased folate levels from baseline.  This multicenter, randomized, double-blind, parallel group study conducted in a U.S. population with folate fortified food evaluated the effect of YAZ in combination with 451 mcg of Metafolin on red blood cell (RBC) folate and plasma folate levels compared to YAZ alone during 24 weeks of treatment. At week 24, the mean changes from baseline were significantly (p<0.0001) higher for women who took YAZ in combination with 451 mcg of Metafolin, as compared to women who took YAZ alone, for RBC folate (420 +/- 347 nmol/L vs. 34.3 +/- 171 nmol/L, respectively) and plasma folate (15.8 +/- 20.4 nmol/L vs. -2.2 +/- 14.6 nmol/L, respectively) levels.

In the U.S. folate study,
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SOURCE Bayer HealthCare Pharmaceuticals, Inc.
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