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

WAYNE, N.J., Sept. 24 /PRNewswire/ -- Bayer HealthCare Pharmaceuticals Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved a new oral contraceptive (OC), Beyaz™ (drospirenone / ethinyl estradiol / levomefolate calcium tablets and levomefolate calcium tablets).  Beyaz is the first and only OC approved to raise folate levels in women who choose an OC for birth control.  In these women, Beyaz raises folate levels for the purpose of reducing the risk of a neural tube defect (NTD) in a pregnancy conceived while taking Beyaz or shortly after discontinuing it.  Beyaz combines the hormone ingredients in the birth control pill YAZ® (drospirenone 3 mg/ ethinyl estradiol 20 mcg) with 451 mcg levomefolate calcium, which is a B vitamin.

The Centers for Disease Control and Prevention, the U.S. Preventive Services Task Force, the March of Dimes and other leading health authorities recommend that all women of childbearing age supplement their diet with at least 400 mcg of folic acid daily.(1),(2),(3)  A well established body of evidence supports folate supplementation as a means to reduce the incidence of neural tube defects  – or birth defects of the brain and spinal cord.(2),(3),(4) Folate supplementation is particularly important at least one month before and three months after conception.(2)    

"Combining an oral contraceptive with folate is important, because women may become pregnant during OC use or shortly after discontinuation, possibly before seeking preconception counseling from their healthcare provider," said Dr. Anita Nelson, Professor of Obstetrics and Gynecology at the Harbor-UCLA Medical Center, Torrance, California.  "For women who want to use an oral contraceptive, Beyaz offers a new option for women to receive daily folate supplementation."

Bayer HealthCare and March of Dimes are working together to raise a
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SOURCE Bayer HealthCare Pharmaceuticals Inc.
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