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 help prevent this type
of defect among mothers who conceive shortly after discontinuing
the drug, the FDA said in a news release.
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,
the FDA said.
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.
More information
The FDA has more about
this approval.