FDA OKs New Birth Control Pill

May 26, 2006 -- The FDA has approved Seasonique, an extended-cycle birth control pill that gives women four periods per year instead of 12 (one per month).

Seasonique is "the next generation" of Seasonale, an extended-cycle birth control pill launched in 2003, states a news release from Barr Pharmaceuticals, the parent company of Duramed Pharmaceuticals, which makes Seasonique and Seasonale.

Seasonique will be available by prescription in July, states a Barr Pharmaceuticals news release announcing the drug's approval. Seasonique is more than 99% effective at preventing pregnancy when taken as directed, states Barr Pharmaceuticals' news release.

Seasonique was tested in a study of about 2,500 U.S. women aged 18-40 who took the drug for 12 months (four cycles, each lasting 91 days), the news release states. Side effects were similar to those seen in trials of other oral contraceptives, according to Barr Pharmaceuticals.

Seasonique vs. Seasonale

What's the difference between Seasonique and Seasonale? Both drugs are designed to give women four periods per year instead of 12. With Seasonale, women take inactive pills during their four yearly periods. With Seasonique, they get a low dose of estrogen during their period, which may provide benefits including less breakthrough bleeding, Barr Pharmaceuticals spokeswoman Carol Cox tells WebMD.

Users of extended-cycle birth control pills may be more likely to experience bleeding or spotting between periods; such bleeding and spotting tends to decrease during later cycles as women keep taking the drug.

"Oral contraceptives are not for every woman," states Barr Pharmaceuticals' news release.

"Serious as well as minor side effects have been reported with the use of hormonal contraceptives," the release continues. "Serious risks include blood clots, stroke, and heart attack. Cigarette smoking increases the risk of serious cardiovascular side effects, especially in women over 35 years."

Oral contraceptives don't protect against HIV -- the virus that causes AIDS -- or other sexually transmitted diseases, the news release also notes.