Bayer Introduces New Oral Contraceptive

Beyaz is claimed to be the first and only oral contraceptive (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. 

It 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.

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Bayer HealthCare Pharmaceuticals Inc. said today (Sept. 27) that the U.S. Food and Drug Administration (FDA) has approved the new OC, Beyaz (drospirenone / ethinyl estradiol / levomefolate calcium tablets and levomefolate calcium tablets).

Recently, FDA also approved ella (ulipristal acetate) tablets for emergency contraception. The prescription-only product prevents pregnancy when taken orally within 120 hours (five days) after a contraceptive failure or unprotected intercourse. (Read: FDA Approves ella for Emergency Contraception)

“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 warns that 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.

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, 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, according to the company, 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

The company informs that 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 expected to be available in October by prescription only.