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Description
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
How Seasonale Birth Control Works
To achieve maximum effectiveness, Seasonale must be taken exactly as directed and at intervals not exceeding 24 hours. Ideally, the tablets should be taken at the same time of the day on each day of active treatment. The dosing regimen for Seasonale is:
- Take 1 pink tablet daily for 84 consecutive days
- Follow with 7 days of white inactive tablets
- Begin taking Seasonale on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, the first pink tablet is taken that day
- Withdrawal bleeding should occur during the 7 days following discontinuation of pink active tablets.
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More Information
SEASONALE® tablets will be available in the SEASONALE® Extended-Cycle Tablet Dispenser containing 84 active pink tablets and 7 white inactive tablets.
To achieve maximum effectiveness, SEASONALE® must be taken exactly as directed and at intervals not exceeding 24 hours. Ideally, the tablets should be taken at the same time of the day on each day of active treatment. The dosing regimen for SEASONALE® is:
Take 1 pink tablet daily for 84 consecutive days.
Follow with 7 days of white inactive tablets.
Begin taking SEASONALE® on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, the first pink tablet is taken that day.
Withdrawal bleeding should occur during the 7 days following discontinuation of pink active tablets.
Serious as well as minor side effects have been reported with the use of hormonal contraceptives. 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 do not protect against HIV infection (AIDS) and other sexually transmitted diseases.
Use of SEASONALE® provides women with more hormonal exposure on a yearly basis than conventional monthly oral contraceptives containing similar strength synthetic estrogens and progestins (an additional 9 weeks per year). While this added exposure may pose an additional risk of thrombotic and thromboembolic disease, studies to date with SEASONALE® have not suggested an increased risk of these disorders. The convenience of fewer menses (4 vs 13 per year) should be weighed against the inconvenience of increased intermenstrual bleeding/spotting.
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