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

 

Beyaz increases the risk of serious conditions including blood clots, stroke, and heart attack. Risk of these conditions is highest during the first year of use. Women should not take Beyaz if they have or have had blood clots, certain cancers, a history of heart attack or stroke, or if they are or may be pregnant.

In addition, Beyaz contains drospirenone, a different kind of hormone that for some may increase potassium too much. Therefore, women should not take Beyaz 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 test to check their potassium level during the first month of taking Beyaz.

"Beyaz is the first of our planned portfolio of Bayer oral contraceptives (OC) containing Metafolin.  Beyaz enables women who choose an OC as their method of contraception to also raise their folate levels during continued use," said Leslie North, Vice President of Marketing, Women's HealthCare, Bayer HealthCare Pharmaceuticals.  "The benefits of folate for NTD risk reduction are well documented.  Women who use Beyaz incorporate folate supplementation as part of their daily OC routine."

About the Clinical Development Program for Beyaz

The FDA approval of Beyaz to raise folate levels is based on a pivotal 24-week clinical trial involving 379 healthy women aged 18-40 years, which found that Beyaz treatment 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 Beyaz on red blood cell (RBC) folate and plasma folate levels compared to YAZ during 24 weeks of treatment.

At week 24, the mean changes from baseline wer
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SOURCE Bayer HealthCare Pharmaceuticals Inc.
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