Wyeth's Lybrel Contraceptive Approved By FDA

By Dan Keane
19:39, May 23rd 2007
162 votes
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Wyeth's Lybrel Contraceptive Approved By FDA

US Food and Drug Administration approved the first oral contraceptive designed to stop women’s monthly periods, called Lybrel, which is manufactured by Wyeth.

Taken daily it can stop a woman's menstrual period indefinitely, as well as prevent pregnancies.

"The risks of using Lybrel are similar to the risks of other conventional oral contraceptives and include an increased risk of blood clots, heart attacks and strokes," the FDA said Tuesday afternoon.

The pill contains a low dose of two hormones already widely used in birth control pills, ethinyl estradiol and levonorgestrel. Compared with traditional oral contraceptives, which are taken for three weeks in a row, followed by a week break to allow for menstruation, the continuous delivery of the hormones prevents the stimulation of a menstrual cycle.

An FDA official warned women that Lybrel is not suitable for everybody, half of the women Lyberl was tested on in trials experienced irregular and unscheduled bleeding.

The newly FDA approved Lybrel sparked a vivid for and against debate. Dr Vanessa Cullins, of the Planned Parenthood Federation of America, said that Lybrel would help those women who suffered from severe headaches, tender breasts, cramps and nausea during their period.

However, Jean Elson, a sociologist at the University of New Hampshire, said: "For women in that situation, I certainly can understand the benefits of taking these kinds of medications, but for most women menstruation is a normal life event - not a medical condition. Why medicate away a normal life event if we're not sure of the long-term effects?"

Toni Belfield, of the Family Planning Association in the UK, said: "For women who don't want to have a period often this is a very good option. It is important that contraception provides women with a choice, not just between different methods, but between how those methods are used.”

 



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