FDA approves combination oral contraceptive containing folate

The FDA has approved a combination estrogen/progestin oral contraceptive that also contains folate.

The new contraceptive (Beyaz, Bayer) contains the same doses of estrogen and progestin as the FDA-approved combination drospirenone/ethinyl estradiol contraceptive (Yaz, Bayer) as well as levomefolate calcium 0.451 mg, and is approved for:

Prevention of pregnancy.
Treatment of symptoms of premenstrual dysphoric disorder in women who choose to use an oral contraceptive for contraception.
Treatment of moderate acne vulgaris in women aged 14 years and older.

The contraceptive is also approved for the secondary indication in women who choose to use an oral contraceptive as their method of contraception, to raise folate levels for the purpose of reducing the risk for a neural tube defect in a pregnancy conceived while taking the product or shortly after discontinuing the product.

Approval was based on a primary efficacy study that compared the new contraceptive with combination drospirenone/ethinyl estradiol for up to 3 months. Study researchers observed an increase in folate levels that persisted after discontinuation among women assigned to the new contraceptive.

The most common adverse events associated with the product include irregular uterine bleeding, nausea, breast tenderness and headache. Other serious adverse events include vascular events, such as blood clots and liver disease. Women aged 35 years and older who smoke are advised not to use this product due to an increased risk for cardiovascular events.

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