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U.S. FDA Approves New Oral Contraceptive That Also Raises Folate Levels
Date:9/24/2010

e significantly (p<0.0001) higher for women who took Beyaz, as compared to women who took YAZ, 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.

The addition of folate to an OC was further evaluated in a separate European study, which looked at YASMIN® (3 mg drospirenone/30 mcg EE) in combination with either 451 mcg of Metafolin or 400 mcg of folic acid for 24 weeks, followed by 20 weeks of treatment with YASMIN only (no folate intake).  This study found that the Metafolin treatment produced maximum mean increases in plasma folate (33.5 +/- 14.5 nmol/L) and in RBC folate (782 +/- 260 nmol/L) levels at 24 weeks.  Upon discontinuation of folate intake, the average RBC and plasma folate levels gradually decreased to starting levels (or baseline) over 20 weeks.

Women who stop taking Beyaz should be advised about maintaining folate supplementation.

The other three indications for Beyaz are supported by five clinical trials involving YAZ, including a one-year contraceptive efficacy study, two 3-cycle studies in women with PMDD, and two 6-cycle studies in women with moderate acne.

The most frequent (greater than or equal to 2%) adverse reactions in the contraception, moderate acne and folate clinical trials were: headache/migraine (5.9%), menstrual irregularities (4.1%), nausea/vomiting (3.5%) and breast pain/tenderness (3.2%). The most frequent (> 2%) adverse reactions in the PMDD clinical trials were: menstrual irregularities (24.9%), nausea (15.8%), headache (13.0%), breast tenderness (10.5%), fatigue (4.2%), irritability (2.8%), decreased libido (2.8%), increased weight (2.5%), and mood changes (2.1%).

About Folate and Neural Tube Defects (NTDs):

Folate is a B vitamin found naturally in some foods, such as leafy, dark green vegetables, citrus fruits and juices, and beans.  Fo
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SOURCE Bayer HealthCare Pharmaceuticals Inc.
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