Bayer HealthCare Pharmaceuticals Inc. announced that the US Food and Drug Administration (FDA) has approved a new oral contraceptive (OC), Beyaz (drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium tablets). Beyaz is the first and only OC approved to raise folate levels in women who choose an OC for birth control. In these women, Beyaz raises folate levels 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. 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.
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 incidence of neural tube defects - or birth defects of the brain and spinal cord. 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 counselling from their healthcare provider," said Dr. Anita Nelson, Professor of Obstetrics and Gynaecology 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."
Bayer HealthCare and March of Dimes are working together to raise awareness about the importance of folate and folic acid. A 2008 March of Dimes survey found that among 2003 women (aged 18-45) interviewed, 39 percent of women took folic acid daily and only 11 percent knew folic acid should be taken before pregnancy.
Women over 35 years old who smoke should not use Beyaz. Smoking increases the risk of serious cardiovascular events 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.
Beyaz is the first and only birth control pill approved by the FDA for four indications: Prevention of pregnancy (99% effective when taken as directed); Treatment of symptoms of premenstrual dysphoric disorder (PMDD) for women who choose the Pill for birth control; Treatment of moderate acne for women at least 14 years of age, who choose the Pill for birth control, and have started having menstrual periods; To raise folate levels in women who choose the Pill for birth control, for the purpose of reducing the risk of a neural tube defect in a pregnancy conceived while taking the product or shortly after discontinuing the product
Beyaz is not indicated during pregnancy. If pregnancy is planned or occurs during treatment with Beyaz, further intake must be stopped. If a woman discontinues use of Beyaz with the intention of becoming pregnant or if she becomes pregnant 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 levels.
Beyaz is in a 24/4 day regimen consisting of 24 days of drospirenone 3 mg/EE 20 mcg with levomefolate calcium (Metafolin) followed by four days of Metafolin only. Beyaz is expected to be available in October by prescription only.
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."
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 US 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 were significantly (p<0.0001) higher for women who took Beyaz, as compared to women who took YAZ, 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 (3 mg drospirenone/30 mcg EE) 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.
Folate is a B vitamin found naturally in some foods, such as leafy, dark green vegetables, citrus fruits and juices, and beans. Folate is also available synthetically for supplementation and is recommended for all women of childbearing age to reduce the risk of a rare type of birth defect that affects the spine or brain (known as a neural tube defect). 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.
Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals business of Bayer HealthCare LLC, a subsidiary of Bayer AG. Bayer HealthCare is one of the world's leading, innovative companies in the healthcare and medical products industry, and combines the activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions.