U.S. FDA Approves New Oral Contraceptive That Also Raises Folate Levels

WAYNE, N.J., Sept. 24 /PRNewswire/ -- Bayer HealthCare Pharmaceuticals Inc. today announced that the U.S. 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 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.(1),(2),(3)  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.(2),(3),(4) Folate supplementation is particularly important at least one month before and three months after conception.(2)    

"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 provider," said Dr. Anita Nelson, Professor of Obstetrics and Gynecology 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.(5)

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."

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 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.

Women who stop taking Beyaz should be advised about maintaining folate supplementation.

The other three indications for Beyaz are supported by five clinical trials involving YAZ, including a one-year contraceptive efficacy study, two 3-cycle studies in women with PMDD, and two 6-cycle studies in women with moderate acne.

The most frequent (greater than or equal to 2%) adverse reactions in the contraception, moderate acne and folate clinical trials were: headache/migraine (5.9%), menstrual irregularities (4.1%), nausea/vomiting (3.5%) and breast pain/tenderness (3.2%). The most frequent (> 2%) adverse reactions in the PMDD clinical trials were: menstrual irregularities (24.9%), nausea (15.8%), headache (13.0%), breast tenderness (10.5%), fatigue (4.2%), irritability (2.8%), decreased libido (2.8%), increased weight (2.5%), and mood changes (2.1%).

About Folate and Neural Tube Defects (NTDs):

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 Savings Card:

Patients can use the Bayer Savings Card, which was created to give new and current patients a direct reduction in costs associated with select Bayer HealthCare oral contraceptives. Beyaz will also be included in the Bayer Savings Card Program upon product availability.  With the card, patients will pay no more than $5 for their first month's prescription and no more than $25 for each additional monthly refill.* To redeem savings, eligible patients must present a valid prescription for Beyaz and the Bayer Savings Card to any participating pharmacy.  To obtain a Bayer Savings Card, patients can contact their healthcare provider, download the card from www.BayerSavingsCard.com or call 1-866-777-5141.  

* Restrictions apply.

For Beyaz, YAZ, and Yasmin full Prescribing Information, including boxed warning, please visit www.beyaz.com, www.YAZ-us.com, and www.yasmin-us.com respectively.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Important Safety Information about Beyaz, Including Boxed Warning

What is Beyaz Prescribed For?  

• To prevent pregnancy
• To treat premenstrual dysphoric disorder (PMDD) in women who choose the Pill for birth control
• To treat moderate acne in women at least 14 years of age who choose to use the Pill for birth control and have started having menstrual periods
• To provide folate supplementation in women who choose the Pill for birth control

Who Should Not Take Beyaz?

Do not use Beyaz if you smoke and are over age 35. Smoking increases your 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.

Do not use Beyaz if you have kidney, liver, or adrenal disease, or if you have or have had blood clots, certain cancers, history of heart attack or stroke, or if you are or may be pregnant.

What are the Most Serious Risks of taking Beyaz?

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.

In addition, Beyaz contains drospirenone, a different kind of hormone that for some may increase potassium too much. Consult your healthcare provider if you are on daily long-term treatment for a chronic condition with medications that may also increase potassium (see below), as you should have a blood test to check your potassium level during the first month of taking Beyaz.

What Medications May Increase Potassium?

NSAIDs – ibuprofen (Motrin®, Advil®), naproxen (Aleve® and others) when taken long-term and daily for arthritis or other problems, potassium-sparing diuretics (spironolactone and others), potassium supplementation, ACE inhibitors (Capoten®, Vasotec®, Zestril®, and others), angiotensin-II receptor antagonists (Cozaar®, Diovan®, Avapro®, and others), aldosterone antagonists, and heparin.

What are the Most Common Side Effects?

In clinical trials, the most common side effects were headache/migraine, menstrual irregularities, nausea/vomiting, breast pain/tenderness, fatigue, irritability, decreased libido, weight gain and mood changes.

Beyaz does not protect against HIV infection (AIDS) or other STDs.

YAZ^® and YASMIN^® Indications & Usage

YASMIN^® (drospirenone 3 mg & ethinyl estradiol 30 mcg) is indicated for the prevention of pregnancy in women who elect to use an oral contraceptive.

YAZ^® (drospirenone 3 mg & ethinyl estradiol 20 mcg) is indicated for:

• The prevention of pregnancy in women who elect to use an oral contraceptive.
• Treatment of the emotional and physical symptoms of premenstrual dysphoric disorder (PMDD) in women who choose to use an oral contraceptive as their method of contraception.
  • The effectiveness of YAZ for PMDD when used for more than 3 menstrual cycles has not been evaluated. YAZ has not been evaluated for the treatment of premenstrual syndrome (PMS).
• Treatment of moderate acne vulgaris
  • In women at least 14 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. YAZ should be used for the treatment of moderate acne only if the patient desires an oral contraceptive for birth control.

Important Safety Information About YAZ^® and YASMIN^®

Who Shouldn't Take Any Oral Contraceptives (OCs)? Some women should not use OCs, including women who have blood clots, certain cancers, a history of heart attack or stroke, as well as those who are or may be pregnant.

In Addition, Who Shouldn't Take YAZ or YASMIN? YAZ and YASMIN each contain drosperinone^®, a different kind of hormone that for some may increase potassium too much. Therefore, you should not take YAZ or YASMIN if you have kidney, liver, or adrenal disease because this could cause serious heart and health problems. Tell your doctor if you are on daily long-term treatment for a chronic condition such as cardiovascular disease or chronic inflammatory disease. Women who take certain drugs (see below) should have their potassium levels checked in the first month of taking YAZ or YASMIN.

What Drugs May Increase Potassium? NSAIDs-ibuprofen (Motrin^®, Advil^®), naproxen (Naprosyn^®, Aleve^®, and others) when taken long-term and daily for arthritis or other diseases or conditions, Potassium-sparing diuretics (spironolactone and others), Potassium supplementation, ACE inhibitors (Capoten^®, Vasotec^®, Zestril^®, and others), angiotensin-II receptor antagonists (Cozaar^®, Diovan^®, Avapro^®, and others), aldosterone antagonists, and heparin.

What Are The Risks Involved With Taking Any Oral Contraceptive (OC)?

OCs do not protect against HIV infection or other STDs.

Frequent (greater than 1%) side effects, which may or may not be related to YASMIN, reported during the YASMIN clinical trials included:

headache, menstrual disorder, breast pain, stomach pain, nausea, vaginal discharge, flu syndrome, acne, vaginal yeast infection, depression, diarrhea, weakness, painful menstrual period, back pain, infection, sore throat, bleeding between menstrual periods, migraine, vomiting, dizziness, nervousness, vaginal infection, sinus infection, bladder infection, bronchitis, inflammation of the intestines and stomach (e.g., stomach flu), allergic reaction, urinary tract infection, itching, mood swings, surgery, rash, upper respiratory infection.

Frequent (greater than 1%) side effects, which may or may not be related to YAZ, reported in all three types of YAZ clinical trials included:

upper respiratory infection, headache, breast pain, vaginal yeast infection, nausea, stomach pain, painful menstrual period, urinary tract infection, accidental injury, sinus infection, mood swings, suspicious Pap smear, weight gain, depression, menstrual disorder, and weakness.

Other frequent (greater than 1%) side effects, which may or may not be related to YAZ, reported in either one or two types of YAZ clinical trials included:

• Contraception trial: white or yellow vaginal discharge, diarrhea, vomiting, vaginal infection, flu syndrome, yeast infection, allergic reaction, bladder infection, tooth disorder, sore throat, infection, fever, surgery, back pain, migraine, indigestion, inflamed nasal passage, acne, inflammation of the intestines and stomach (eg, stomach flu), bronchitis, skin disorder, bleeding between menstrual periods, decreased libido, pain, increased cough, dizziness, pain in extremity, and pelvic pain.
• PMDD trials: bleeding between menstrual periods, decreased libido, nervousness, heavy menstrual bleeding, pain in extremity, migraine, vaginal infection, elevated cholesterol or triglycerides, back pain, diarrhea, increased appetite, enlarged belly, and acne.
• Acne trials: irregular uterine bleeding, flu syndrome, heavy menstrual bleeding, inflammation of the intestines and stomach (eg, stomach flu), tooth disorder, infection, vomiting, sore throat, joint pain, bronchitis, inflamed nasal passage, absence of menstrual periods, and urine abnormality.

About Bayer HealthCare Pharmaceuticals Inc.

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.  As a specialty pharmaceutical company, Bayer HealthCare Pharmaceuticals provides products for Diagnostic Imaging, General Medicine, Hematology, Neurology, Oncology and Women's Healthcare.  The company's aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.

BAYER (reg'd), the Bayer Cross (reg'd), Beyaz™, YAZ (reg'd) and Yasmin (reg'd) are trademarks of Bayer HealthCare Pharmaceuticals.  Levomefolate calcium (Metafolin®) is licensed and supplied by Merck & Cie, Switzerland. Metafolin® is a registered trademark of Merck KGaA, Germany.

Forward-Looking Statements

This news 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 www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

* Nationally representative telephone surveys conducted by Gallup, targeting approximately 2,000 English-speaking women ages 18-45 each year. Margin of error is +/- 3%. (Survey questions included: What type of vitamin or mineral supplements do you take? and unprompted basis: What have you heard, read, or seen about folic acid?)

** Levomefolate calcium (Metafolin®) is licensed and supplied by Merck & Cie, Switzerland. Metafolin® is a registered trademark of Merck KGaA, Germany.

(1) Centers for Disease Control and Prevention. Folic Acid: Recommendations. Available at: http://www.cdc.gov/ncbddd/folicacid/recommendations.html. Accessed on 9/22/2010.

(2) 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.

(3)  The March of Dimes. Pregnancy and Newborn Health Education Center: Folic Acid. Available at: http://www.marchofdimes.com/hbhb_syndication/173_769.asp. Accessed on 9/22/2010.

(4) 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.

(5) March of Dimes Folic Acid Surveys, conducted by Gallup. Available at: www.marchofdimes.com/peristats.  Accessed on 9/22/2010.

SOURCE Bayer HealthCare Pharmaceuticals Inc.

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