The Food and Drug Administration on Sept. 24 approved Beyaz, an oral contraceptive that contains a folate.
Levomefolate calcium is a folic acid metabolite, and a B-vitamin “that helps produce and maintain new cells in the body,” according to an FDA announcement. Low folate levels in women of child-bearing age have been associated with neural tube defects, such as spina bifida; current recommendations suggest that women of child-bearing age take supplemental folate.
Beyaz, manufactured by Bayer HealthCare Pharmaceuticals Inc., is based on the previously approved oral contraceptive YAZ and contains the same doses of estrogen and progestin (ethinyl estradiol, 20 mcg; drospirenone, 3 mg). Beyaz also contains 0.451 mg of levomefolate calcium.
Beyaz shares YAZ’s approved indications: pregnancy prevention, treatment of premenstrual dysphoric disorder (PMDD) symptoms in women who use OCs for contraception, and treatment of moderate acne in patients aged 14 years and older who have chosen to use an OC for birth control. Beyaz is approved for the secondary indication of raising folate levels to reduce risk of neural tube defects in women who conceive while using the product or shortly after discontinuing it.
A multicenter, double-blind, randomized controlled trial of 379 women aged 18-40 years in the United States who received YAZ or Beyaz for 24 weeks showed that Beyaz increased folate levels. A German study showed that folate levels remained elevated for several weeks following discontinuation of the drug. Previous YAZ clinical trials provided safety and efficacy data for contraception, PMDD, and acne indications for Beyaz.
Side effects most often reported by users of OCs are irregular bleeding, nausea, breast tenderness, and headache. Serious side effects include blood clots and liver disease. All OC users, especially those older than age 35, should not smoke. Side effects of Beyaz are expected be similar to those of YAZ.