Bayer HealthCare Pharmaceutical's Natazia (estradiol valerate and estradiol valerate/dienogest) tablets have been approved by the Food and Drug Administration (FDA) as an oral contraceptive (OC) for the treatment of heavy menstrual bleeding (HMB) that is not caused by any diagnosed condition of the uterus.
This approval makes Natazia the first and only oral contraceptive indicated for the treatment of HMB.
As the first oral contraceptive treatment approved for heavy menstrual bleeding in women without organic pathology who choose an OC for contraception, Natazia represents a new treatment approach for appropriate women with this medical condition, said Pamela A. Cyrus, M.D., vice president and head of U.S. Medical Affairs, Bayer HealthCare Pharmaceuticals.
In May 2010, Natazia received approval for the prevention of pregnancy. The contraceptive efficiency of Natazia has not been evaluated in women with a body mass index (BMI) greater than 30 kg/m2.
Some clinical trials conducted with Natazia and placebo treatments paved the way for Natazia's approval. Patients, who were treated with Natazia, had achieved a significant reduction in menstrual blood loss compared with placebo patients.
Some common side effects of the Natazia tablet's clinical trials were headache/migraine, breast pain/discomfort/tenderness, menstrual disorders, nausea/vomiting, acne, mood changes, and weight gain.
The company emphasizes some safety measures to be taken before adopting a Natazia treatment. Pregnant ladies and patients with a history of blood clots, certain cancers, and heart attack are advised to avoid using the tablet.