- The Washington Times - Saturday, September 6, 2003

ASSOCIATED PRESS

The government yesterday approved the first birth-control pill specially designed to reduce the frequency of women’s periods — from once a month to four times a year. Hence the name: Seasonale.

The pills aren’t a new chemical. They contain the same combination of low-dose estrogen and progestin found in many oral contraceptives.

Nor is the idea of menstrual suppression new. For decades, many doctors have told women how they can skip a period by continually taking the active birth-control pills in each month’s supply and ignoring the week of dummy pills in each packet.

But Seasonale promises to make the option a little more convenient, with packaging that gives women 12 straight weeks of active pills and then a week of dummy pills for their period. And the Food and Drug Administration’s approval means menstrual suppression could become more common, as Seasonale’s advertising alerts women to the option.

Seasonale isn’t perfect, however, the FDA cautioned.

While women have fewer scheduled periods, studies show Seasonale users have about twice the risk of unexpected “breakthrough” bleeding between periods as woman taking conventional monthly cycle pills, especially in the first few cycles of use.

Also, 7.7 percent of Seasonale users dropped out of studies of the drug citing unacceptable bleeding, compared with 1.8 percent of women taking conventional monthly pills. Some Seasonale users had so much breakthrough bleeding that their total days of bleeding over a year were no less with the new drug than with regular pills, the FDA said.

“Each woman will respond to this product somewhat differently,” said FDA’s Dr. Scott Monroe. “Some will find they respond entirely as the product was designed to function, and others will have increased intermenstrual bleeding to the extent that they choose not to continue with the product.”

Maker Barr Laboratories plans to have prescription-only Seasonale in pharmacies by November.

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