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The first birth-control pill meant to put a stop to women’s monthly periods indefinitely won federal approval Tuesday.
Called Lybrel, it’s the first such pill to receive Food and Drug Administration approval for continuous use. When taken daily, the pill can halt women’s menstrual periods indefinitely and prevent pregnancies.
The pill isn’t for everyone, an FDA official said. About half the women enrolled in studies of Lybrel dropped out, said Dr. Daniel Shames, a deputy director in the FDA’s drugs office. Many did so because of the irregular and unscheduled bleeding and spotting that can replace scheduled menstruation.
In recent years, as the hormone content of birth-control pills has dipped, failure rates have climbed. The FDA is considering whether to establish an acceptable failure rate for the pills. In January, a panel of agency advisers said less-effective birth-control pills should still merit federal approval if they promise other benefits, including improved safety.
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