US Food and Drug Administration has approved a new combined contraceptive Beyaz, containing estrogen /progestin possessing contraceptive action and folate (levomefolat calcium).
Folate is a derivative of folic acid and is recommended for application by women of childbearing age. Lack of folate can affect a child's health, causing various congenital malformations, including damage to the brain and spinal cord. The new drug contains folate, so it prevents the risk of such disorders in women who become pregnant shortly after the cessation of contraceptive use.
Beyaz has been tested in clinical studies in the U.S. with the participation of nearly 400 women aged 18 to 40 years. Major Beyaz side effects included: nausea, breast tenderness, headache.
Beyaz is not recommended for women older than 35 years because of high risk of cardiovascular complications, especially thrombosis.
Beyaz is based on previously approved contraceptive called YAZ, which contains the same combination of estrogen and progestin.