MONDAY, Sept. 27 (HealthDay News) -- Beyaz, a combination estrogen/progestin contraceptive that also contains a folate, has been approved by the U.S. Food and Drug Administration.
The folate, levomefolate calcium, is a B-vitamin that's among a class of vitamins recommended for women of childbearing age. Lack of dietary folate has been associated with neural tube birth defects, which involve deformities of the fetal brain or spinal cord. The newly approved drug is designed to boost folate levels and help prevent this type of defect among mothers who conceive shortly after discontinuing the drug.
Beyaz was studied in a multi-center U.S. trial involving 379 women aged 18 to 40. The most frequently reported side effects included uterine bleeding, nausea, breast tenderness and headache. Other serious side effects included blood clots and liver disease.
Women 35 or older should not use Beyaz, which could increase their risk of "serious cardiovascular events," the agency said.
Beyaz is based on the already approved contraceptive YAZ, which includes the same amounts of estrogen and progestin, the FDA said.
The newly approved drug is produced by Bayer HealthCare Pharmaceuticals.
The FDA has more about this approval.