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FDA Approves Seasonale --- Oral Contraceptive

BETHESDA, MD -- September 8, 2003 -- The FDA has approved Seasonale, a new choice in oral contraceptives for women for prevention of pregnancy. Seasonale is a 91-day oral contraceptive regimen. Tablets containing the active hormones are taken for 12 weeks (84 days), followed by one week (7 days) of placebo (inactive) tablets. Conventional oral contraceptive use is based on a 28-day regimen (21 days of active tablets followed by 7 days of placebo tablets). Seasonale contains a progestin (levonorgestrel) and an estrogen (ethinyl estradiol), which are active ingredients in already approved oral contraceptives.

Under Seasonale's dosing regimen the number of expected menstrual periods that a woman usually experiences are reduced from once a month to about once every three months. As with the conventional 28-day regimen, women will have their period while taking the placebo tablets.

Although Seasonale users have fewer scheduled menstrual cycles, the data from clinical trials show that many women, especially in the first few cycles of use, had more unplanned bleeding and spotting between the expected menstrual periods than women taking a conventional 28-day cycle oral contraceptive.

Like other available oral contraceptives, Seasonale is effective for prevention of pregnancy when used as directed. The risks of using Seasonale are similar to the risks of other conventional oral contraceptives and include an increased risk of blood clots, heart attack, and stroke. The labeling also carries the warning that cigarette smoking increases the risk of serious cardiovascular side effects from use of combination estrogen and progestin containing contraceptives. Birth control pills do not protect against HIV infection (AIDS) or other sexually transmitted diseases.

Since Seasonale users can expect to have fewer periods, the label also advises women to consider the possibility that they may be pregnant if they miss any scheduled periods. Women should discuss contraceptive use and the precautions and warnings for use of the drug with their doctors.

Seasonale is manufactured by Barr Laboratories of Pomona, New York.

Source: The Food and Drug Administration

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