December 17, 2010
For use outside the US only

FDA approves Bayer's new oral contraceptive Safyral

Oral contraceptive raises folate levels, reducing the risk of neural tube defects

Berlin, December 17, 2010 - The U.S. Food and Drug Administration (FDA) has approved Bayer's new oral contraceptive SafyralTM which is the second in Bayer's oral contraceptive portfolio containing folate. In women who choose an oral contraceptive (OC) for birth control, Safyral raises folate levels with the aim of reducing the risk of a neural tube defect (NTD) in a pregnancy conceived while taking Safyral or shortly after discontinuing it. Safyral combines the hormone ingredients of the birth control pill Yasmin® (drospirenone/ethinyl estradiol) with Metafolin®*, a stable form of naturally occurring folate predominantly found in food. Folates belong to the group of B vitamins. In September 2010, the FDA approved BeyazTM, the first OC containing folate.

"Combining oral contraceptives with folate supplementation is an important contribution to existing measures for raising folate levels to reduce the risk of neural tube defects," said Dr. Flemming Oernskov, Head of General Medicine at Bayer Schering Pharma AG. "With the approval of Safyral, we now offer women a choice of two OCs containing folate."

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. A well-established body of evidence supports folate supplementation as a means to reduce the risk of neural tube defects - birth defects of the brain and spinal cord. Folate supplementation is particularly important at least one month before and three months after conception.

Women who discontinue OCs or do not take them correctly may become pregnant before seeking preconception counseling from their healthcare provider until after they become pregnant. Therefore combining an oral contraceptive with folate is a significant medical advance.

Safyral is in a 21/7 day regimen consisting of 21 days of drospirenone 3 mg/ethinyl estradiol 30 mcg with Metafolin® (451 mcg levomefolate calcium) followed by seven days of Metafolin only. Safyral is expected to be available in the U.S. in mid-January 2011 by prescription only.

About the Clinical Development Program for Safyral
The FDA approval of Safyral, as well as of Beyaz, to raise folate levels in women who choose an OC for contraception are based on two pivotal studies.

A 24-week clinical trial involving 379 healthy women aged 18-40 years, which found that YAZ® (drospirenone/ethinylestradiol) 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.

The addition of folate to an OC was further evaluated in a separate European study, which looked at Yasmin® 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 Safyral should be advised about maintaining folate supplementation.

* Levomefolate calcium (Metafolin®) is licensed and supplied by Merck & Cie, Switzerland. Metafolin® is a registered trademark of Merck KGaA, Germany.
Centers for Disease Control and Prevention. Folic Acid: Recommendations. Available at: Accessed on 9/22/2010.
U.S. Preventive Services Task Force. Folic acid for the prevention of neural tube defects: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med 2009;150:626-31.
The March of Dimes. Pregnancy and Newborn Health Education Center: Folic Acid. Available at: Accessed on 9/22/2010.
Centers for Disease Control and Prevention. Recommendations for the use of folic acid to reduce the number of cases of spina bifida and other neural tube defects. MMWR 1992;41(No.RR-14): 1-6.

To learn more about contraception, please visit:

About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of EUR 15,988 million (2009), is one of the world's leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions. Bayer HealthCare's aim is to discover and manufacture products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 53.400 employees and is represented in more than 100 countries. Find more information at

Find more information at

Forward-looking statements<br/>This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.