Bayer's SAFYRAL oral contraceptive receives FDA approval

Dec 17 2010

Bayer HealthCare Pharmaceuticals, Inc. today announced the U.S. Food and Drug Administration (FDA) has approved a new oral contraceptive (OC), SAFYRAL™ (drospirenone 3 mg/ ethinyl estradiol 30 mcg/ levomefolate calcium 451 mcg tablets and levomefolate calcium 451 mcg tablets).  In women who choose an OC for birth control, SAFYRAL raises folate levels for the purpose of reducing the risk of rare neural tube defects (NTDs) in a pregnancy conceived while taking SAFYRAL or shortly after discontinuing it.  SAFYRAL provides the birth control YASMIN® (drospirenone 3 mg/ ethinyl estradiol 30 mcg) with 451 mcg levomefolate calcium, which is a B vitamin.

SAFYRAL is the second Bayer OC which contains folate.  In September, the FDA approved Beyaz™ (drospirenone 3 mg/ ethinyl estradiol 20 mcg/ levomefolate calcium 451 mcg tablets and levomefolate calcium  451 mcg tablets), the first OC approved by the FDA to raise folate levels in women who choose an OC for birth control.

"With the FDA approval of Safyral, Bayer now offers two oral contraceptives that contain folate," said Leslie North, Vice President of Marketing, Women's HealthCare, Bayer HealthCare Pharmaceuticals.  "SAFYRAL and Beyaz are part of Bayer's growing women's health franchise, and these new products reinforce our commitment to providing women various contraceptive options."

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 incidence of neural tube defects  – rare birth defects of the brain and spinal cord.  These rare birth defects happen in the first few weeks of pregnancy – often before a woman finds out she is pregnant.  As a result, daily folate supplementation is particularly important at least one month before and three months after conception.

"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 providers," said Dr. Anita Nelson, Professor of Obstetrics and Gynecology at the Harbor-UCLA Medical Center, Torrance, California.  "For women who already use YASMIN for contraception, SAFYRAL offers these women a new option to receive daily folate supplementation as part of their OC routine."

Women should not use SAFYRAL if they smoke and are over age 35.  Smoking increases the risk of serious side effects from the Pill, which can be life-threatening, including blood clots, stroke or heart attack.  This risk increases with age and number of cigarettes smoked.

Patients are advised to alert their healthcare provider if they are taking folate supplements.  SAFYRAL is not indicated during pregnancy.  SAFYRAL has 99 percent contraceptive efficacy when used as directed.  If pregnancy occurs during treatment with SAFYRAL, further intake must be stopped.  If a woman discontinues use of SAFYRAL either with the intention of becoming pregnant or if she discontinues due to pregnancy while on the product, she is strongly encouraged to speak with her healthcare provider about taking a multivitamin with folic acid or another folate to maintain recommended folate intake.

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

Women should not use SAFYRAL if they have kidney, liver, or adrenal disease because this could cause serious heart and health problems, or if they have or have had blood clots, certain cancers, history of heart attack or stroke, or if they are or may be pregnant.  SAFYRAL increases the risk of serious conditions including blood clots, stroke and heart attack.  Smoking increases these risks, especially in women over 35.  The risk of blood clots is highest during the first year of use.  

In addition, SAFYRAL contains drospirenone, a different kind of hormone that for some may increase potassium too much.  Women should consult with their healthcare provider if they are on daily long-term treatment for a chronic condition with medications that may also increase potassium, as they should have a blood test to check their potassium level during the first month of taking SAFYRAL.