Four Phase Contraceptive Dosing

FDA approves first contraceptive pill to use four-phase dosing.
The AP (5/7) reports, The Food and Drug Administration has given its approval to Natazia, "a novel birth control pill from Bayer Healthcare that combines" the "hormones estrogen and progestin in doses that adjust four times throughout a woman's period cycle. The pill is the first birth control product to use four-phase dosing, according to the FDA."
Bloomberg News (5/7, Peterson) reports, "Natazia is the first oral contraceptive to use a synthetic estrogen called estradiol valerate in combination with a progestin called dienogest, Bayer said...in an emailed statement. Other birth control pills sold in the US contain ethinyl estradiol, the company said." The drug also may "offer a new treatment option for women who suffer from heavy or prolonged menstrual periods, Bayer said in October after presenting clinical trial data" in which the drug, compared to placebo, "reduced menstrual bleeding in a study of 231 women" over the course of 90 days.
"The drug was evaluated by more than 1,800 women during clinical testing in North America and Europe," HealthDay (5/6) reported. "The most common adverse effects were irregular bleeding, breast tenderness, headache, nausea and vomiting, weight gain, and acne." The FDA warned that women "older than 35 who smoke should not use the product," because it could put them at risk for potentially serious cardiovascular problems. MedPage Today (5/6, Gever) and Reuters (5/7) also covered the story.
Birth control pill should be available OTC, advocates say. NBC Nightly News (5/6, story 7, 2:40, Williams) reported, "Hard for a lot of people to believe the birth control pill has been around now for half a century. It became a game changer for millions of American women and for American society." NBC (Snyderman) added, "Today, an estimated 12 million American women use the pill and about 80% will use it at some point in their reproductive lives." Yet, Snyderman noted, "Just because it's readily available doesn't mean it's always easy to get."
USA Today (5/7, Rubin) adds, "On the eve of the birth-control pill's 50th anniversary...it's time to clear up some misconceptions, if you'll pardon the expression." The FDA "approved the first pill in the first year of the Swinging Sixties, but the pill did not spark the sexual revolution. Nor did it cause a sudden drop in the US fertility rate, which didn't bottom out until the early 1970s." Nevertheless, "the pill's influence has been lasting and pervasive. It became a symbol of women's rights and generational change -- and, for a time, the focus of a debate over whether it led to declining morals." Yet, "women became dependent on doctors for contraception, because the pill was, and still is, available only with a prescription." Some women's advocates argue that pills today are much safer; therefore, they should be available without a prescription.