FDA Approves Oral Contraceptive Containing Folate

September 24, 2010

September 24, 2010 — The US Food and Drug Administration (FDA) today approved an oral contraceptive — the first of its kind — that is intended both to prevent pregnancy and reduce the risk for neural tube defects in newborns if and when users of the pill give birth.

The new contraceptive, Beyaz (Bayer HealthCare Pharmaceuticals), contains levomefolate calcium, a metabolite of folic acid that helps produce and maintain new cells in the body. Low folate levels in women have been linked with neural tube defects in their children such as spina bifida, resulting in recommendations that women of childbearing age supplement their diet with folate.

"Combining an oral contraceptive with folate is important, because women may become pregnant during [oral contraceptive] 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–University of California at Los Angeles Medical Center, Torrance, California, in a company press release. "For women who want to use an oral contraceptive, Beyaz offers a new option for women to receive daily folate supplementation."

The approval is based on the already-approved oral contraceptive drospirenone/ethinyl estradiol (Yaz, Bayer HealthCare Pharmaceuticals), which contains the same doses of estrogen and progestin.

Like Yaz, Beyaz is approved for:

  • Preventing pregnancy

  • Treating symptoms of premenstrual dysphoric disorder (PMDD) in women who choose to prevent pregnancy with an oral contraceptive

  • Treating moderate acne vulgaris in women at least 14 years old who desire an oral contraceptive for birth control

For women who choose an oral contraceptive as their method of birth control, Beyaz is also approved for raising folate levels to reduce the risk for neural tube defects in offspring.

Beyaz increased folate levels in women who participated in a multicenter, double-blind, randomized, controlled US trial designed to determine product efficacy. In a Germany study, folate levels remained elevated for several weeks after Beyaz was discontinued.

Beyaz safety and efficacy data for the contraception, PMDD, and acne indications came from previous clinical trials of Yaz.

The FDA said that the clinical trials of Beyaz did not yield any findings that would suggest it differs from Yaz in terms of its overall safety profile. The agency expects that the most common adverse events for Beyaz will be the same as those for Yaz. Adverse effects most frequently reported by users of combined oral contraceptives are irregular uterine bleeding, nausea, breast tenderness, and headaches.

As with other oral contraceptives, Beyaz is not intended for use in women older than 35 years who smoke.

More information about today's FDA announcement is available on the agency's Web site.


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