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FDA Approves Bayer Oral Contraceptive

From UPI Health News (Business) (May 7, 2010)

The U.S. Food and Drug Administration approved Natazia tablets that contain estrogen and progestin, Bayer HealthCare Pharmaceuticals said.

Current oral contraceptives contain ethinylestradiol -- an estrogen -- but Natazia contains estradiol valerate and estradiol valerate/dienogest, a progestin, to prevent pregnancy.

"Every woman’s body reacts differently to hormones, so it is important that they have a choice in birth control options," Dr. Anita Nelson, a professor of obstetrics and gynecology at the Harbor-University of California, Los Angeles, Medical Center, in Torrance, Calif., said in a statement.

"Natazia may be a good option for women to consider when making a decision with their healthcare provider about which birth control option is right for them."

Natazia, expected to be available in the summer, has not been evaluated in women with a body mass index of more than 30.

Women using combination oral contraceptives, including Natazia, should be advised not to smoke because it could increase their risk of serious cardiovascular side effects, Nelson said.

Natazia is associated with increased risk including: venous and arterial thrombotic and thromboembolic events such as heart attack or stroke, gallbladder disease, hypertension, ruptured ovarian cyst and uterine leiomyoma, Bayer said.


Posted: May 2010