FDA approves first oral contraceptive that increases folate levels

September 27th, 2010 - 9:44 pm ICT by BNO News  

WAYNE, NEW JERSEY (BNO NEWS) — Bayer HealthCare Pharmaceuticals Inc. on Monday announced that the U.S. Food and Drug Administration (FDA) has approved a new oral contraceptive (OC) that increases folate levels to helps reduce the risk of a rare type of birth defect.

Beyaz is the first and only OC approved to raise folate levels in women - who choose an OC for birth control - 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.

Folate is a B vitamin found naturally in some foods, such as leafy, dark green vegetables, citrus fruits and juices, and beans, but is also available synthetically for supplementation and is recommended for all women of childbearing age to reduce the risk of neural tube defect, which is a rare type of birth defect that affects the spine or brain.

These defects happen in the first few weeks of pregnancy – often before a woman finds out she is pregnant. For that reason, daily folate supplementation should begin at least one month prior to pregnancy.

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.

“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.” Nelson added.

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