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FDA approves Seasonale extended-cycle oral contraceptive

ROCKVILLE, MD., September 5, 2003 -- The FDA has approved Seasonale (levonorgestrel and ethinyl estradiol) 0.15 mg/0.03 mg tablets, a new choice in oral contraceptives for women, for prevention of pregnancy.

Seasonale, a 91-day oral contraceptive regimen manufactured by Barr Laboratories, will be available by prescription to women at the end of October.

Under the Seasonale 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.

Clinical data

The clinical data supporting FDA approval of the Seasonale product resulted from a randomized, open-label, multi-center trial that ended in March 2002 and an extension to that trial. In the trials, Seasonale was found to prevent pregnancy and had a comparable safety profile to a more traditional oral contraceptive.

In the trial, the most reported adverse events were nasopharyngitis, headache and intermenstrual bleeding or spotting.

Barr says Seasonale has been formulated using well-established components, long recognized as safe and effective when used in a 28-day regimen. Seasonale offers four periods per year, compared to 13 per year with traditional oral contraceptives.

In prescribing Seasonale, the convenience of fewer planned menses (4 per year instead of 13 per year) should be weighed against the inconvenience of increased intermenstrual bleeding and/or spotting. A recently published Roper study found that, when given the choice, nearly two-thirds of women would be interested in reducing their number of periods to 4 times per year.

Oral contraceptives: contraindications, interactions, side effects

Oral contraceptives are not for every woman. Serious risks associated with birth control pills that can be life threatening include blood clots, stroke and heart attack. These risks are increased in women who smoke cigarettes, especially women over 35. Women who use oral contraceptives should not smoke. Some women should not use birth control pills, including women who have had a heart attack, stroke, blood clots, certain cancers or liver diseases, unexplained vaginal bleeding, and those who are or may be pregnant. Birth control pills do not protect against HIV infection (AIDS) or 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.

Sources: FDA Talk Paper, Barr Laboratories

Posted: September 2003