ľֱ

Folate-Fortified Birth Control Pill Approved

— The FDA has approved an oral contraceptive containing folate to help prevent birth defects after women go off the pill.

MedpageToday

The FDA has approved an oral contraceptive containing folate to help prevent birth defects after women go off the pill.

Called Beyaz, the product contains the same estrogen-progestin combination as the contraceptive pill Yaz -- plus 0.451 mg of levomefolate calcium.

Levomefolate calcium is a metabolite of folic acid. Supplementation with this B-vitamin is recommended for all women of childbearing age because low folate levels are associated with neural tube defects such as spina bifida, the FDA said in a release announcing approval of Beyaz.

The Yaz product is approved for preventing pregnancy and treating symptoms of premenstrual dysphoric disorder or moderate acne in women wanting to use an oral contraceptive.

Those approvals also apply to Beyaz, along with the new indication of raising folate levels in oral contraceptive users for preventing neural tube defects in offspring conceived while using the product or shortly after discontinuing it, according to the FDA press release.

The product's manufacturer, Bayer HealthCare Pharmaceuticals, pointed out that both products are 99% effective in preventing pregnancy when used as directed.

As with other oral contraceptives based on hormone combinations, Beyaz should be avoided by women older than 35 who smoke because of increased risk of cardiovascular events.

The FDA said clinical trials with Beyaz indicated the same overall safety profile seen with Yaz.

Bayer HealthCare Pharmaceuticals is the U.S.-based business arm of Bayer HealthCare LLC -- a subsidiary of Bayer AG, headquartered in Germany.