US FDA approves Safyral

The US FDA has approved Bayer’s oral contraceptive Safyral 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 Beyaz, 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 US 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 US in mid-January 2011 by prescription only.