Your Health

FDA Approves An Oral Contraceptive

Posted 11/12/2010

FDA Approves An Oral Contraceptive

(NAPSI) - The U.S. Food and Drug Administration (FDA) approved Natazia™ (estradiol valerate and estradiol valerate/dienogest) tablets, a combination oral contraceptive, on May 6, 2010 for the prevention of pregnancy. Natazia is available by prescription. Natazia has not been studied in women who are obese (BMI > 30).

Natazia, which is manufactured by Bayer HealthCare Pharmaceuticals, Inc., is the only Pill to combine the progestin DNG (dienogest) with EV (estradiol valerate)--a synthetic estrogen that converts to estradiol in your body. Like other pills, Natazia is highly effective at preventing pregnancy when taken as directed, and may give you shorter, lighter periods.

“Every woman’s body reacts differently to hormones, so it is important that they have a choice in birth control options,” said Anita Nelson, M.D., professor of obstetrics and gynecology at the Harbor-UCLA Medical Center, Torrance, California. “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 delivers different doses of EV and the progestin dienogest (DNG) at different times during the cycle at the lowest effective doses of these hormones.

Combination pills, such as Natazia, contain two types of hormones, an estrogen and a progestin. They work in two ways:

− They “trick” the body into thinking it is pregnant by preventing the release of an egg (ovulation). Without an egg to be fertilized, you can’t become pregnant;

− The cervical mucus is thickened, which may make it hard for the sperm to travel toward the egg and fertilize it, in case an egg is released.

Important Considerations

Who should not take Natazia?

Do not use Natazia if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects (heart and blood vessel problems) from birth control pills, including death from heart attack, blood clots or stroke. This risk increases with age and the number of cigarettes you smoke.

Do not use Natazia if you have or have had blood clots, certain cancers, history of heart attack or stroke, or if you are or may be pregnant.

What are the most serious risks of taking birth control pills?

The Pill increases the risk of serious conditions including blood clots, stroke and heart attack. The risk of these conditions is highest during the first year of use.

The Pill does not protect against HIV infection, AIDS, or other STDs.

What are the most common side effects?

In clinical trials, the most common side effects were headache/migraine, irregular periods, breast pain or tenderness, nausea/vomiting, acne, and weight gain.

Tell your healthcare provider about all medicines and herbal products you take including daily long-term treatment for chronic conditions such as seizures or cardiovascular disease.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see www.Natazia.com or call 1-888-84-Bayer for full prescribing information.

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