FDA Approves First 4-Phasic Oral Contraceptive

The US Food and Drug Administration (FDA) has approved a combination hormonal contraceptive tablet containing estradiol valerate and dienogest (Natazia; Bayer HealthCare Pharmaceuticals).

The product offers 4 progestin/estrogen dosing combinations during each 28-day cycle and is the first “4-phasic” oral contraceptive to be marketed in the United States. It also is the first contraceptive to contain the “bioidentical” synthetic estrogen estradiol valerate, rather than ethinyl estradiol.

“Nearly 12 million women in the United States and more than 100 million women worldwide currently use oral contraceptives,” said Scott Monroe, MD, director of the FDA’s Division of Reproductive and Urologic Products, in an agency news release. “The approval of Natazia provides another option for women who choose to use an oral contraceptive as their method of contraception.”

This is not the initial offering of the 4-Phasic Pill, Estradiol valerate/dienogest contraceptive tablets (marketed as Qlaira) previously were approved for use in the European Union. The proposed benefit of this combination is decreased menstrual bleeding. One study there was a 16% absence of menstruation in patients taking the 4-Phaic Pill.

Contraindications and warnings are the same as all other oral contraceptives, and the safety labeling for estradiol valerate/dienogest strongly advises that women not smoke because of an increased risk for serious cardiovascular events that increases with age and number of cigarettes, particularly for those older than 35 years.

J. Kyle Mathews, MD

Plano Ob Gyn Associates

Plano Urogynecology Associates

Tags: 4-Phaic, Bioidentical, estradiol, estradiol valerate, estrogen, European Union, kyle mathews, Natazia, oral contraceptive, Plano Ob Gyn Associates, synthetic estrogen, United States, women | Category: Gynecology, News & Education |