FDA Approves Lybrel, a Pill Designed to Stop Menstruation
Corrected 5/25/07. A previous version of this article incorrectly stated the percentage of Lybrel users who experienced intermittent spotting after using the drug for a full year.
With the Food and Drug Administration's approval today of the first birth control pill to stop menstruation, women may soon come to view their period as just another lifestyle choice. Drug manufacturers have already tinkered with the monthly flow; Berlex's Yaz and Warner Chilcott's Loestrin shorten periods to three days or less, and Duramed's Seasonique, and the older Seasonale, reduce them to three or four times a year. But Lybrel, made by Wyeth, would stop them altogether.
Gynecologists, by and large, are in favor of the new option; many of them for years have been telling women to skip the seven placebo pills in the regular 28-day pack—which allow a period—and just go on to the next pack. Skipping periods this way helps to alleviate premenstrual syndrome, painful periods, or excessive bleeding. What's more, the light bleeding that occurs on the monthly weekoff from traditional pills isn't the same as the heavy bleed that occurs when the body sheds a thickened lining during natural menstruation. "The fact that birth control pills were prescribed as monthly cycles for all these years is the reflection of what someone thought women would want as opposed to what was physiologically necessary," says Paul Blumenthal, a contraception researcher and professor of obstetrics and gynecology at Stanford University School of Medicine. "Women don't need menstrual periods. In fact, historically they've had few of them because they spent most of their time either pregnant or nursing."
But taking contraceptives continuously does have a downside: Instead of predictable bleeding every month, women often get spotting at random times. Of the 2,402 patients initially enrolled in the Wyeth-sponsored clinical trial of Lybrel published last year in the journal Contraception, only 921 were still taking the contraceptive a year later. Many had side effects like nausea and headaches, typical of oral contraceptives, but others dropped out of the study because of unpredictable bleeding or spotting. Of those who took Lybrel for a full year, about 20 percent still had intermittent spotting and another 20 percent had bleeding heavy enough to require the use of a sanitary napkin or tampon. "Women may be under the impression that this pill will take care of the nuisance of having periods and that isn't the case," says Jerilynn Prior, a professor of endocrinology at the University of British Columbia who directs the Center for Menstrual Cycle and Ovulation Research. Unpredictable bleeding is also a problem with Seasonique and Seasonale and the progesterone-only shot Depo-Provera, which also stops periods.
The solution for women may lie in trying different brands of oral contraceptives to see which dose of estrogen and progestin, the two active hormones in oral contraceptives, causes the fewest bleeding problems. Women metabolize these hormones differently, so some may experience more bleeding with a higher dose of hormones and others with a lower dose, explains Leslie Miller, a clinical associate professor of obstetrics and gynecology at the University of Washington in Seattle who has conducted studies on menstruation cessation using generic birth control pills.
With 90 micrograms of levonorgestrel (a progestin) and 20 micrograms of ethinyl estradiol (an estrogen), Lybrel contains a low dose of hormones. Other pill formulations have up to twice as much estrogen and use different doses and types of progestins. "I don't think women need another brand-name contraceptive like Lybrel," Miller adds. She frequently prescribes generic birth control pills to stop periods in women who don't wish to have any.
The long-term effects of taking oral contraceptives for years or decades remain unknown. Studies indicate that birth control pills protect against endometrial and ovarian cancer, while they might slightly increase the risk of breast cancer, particularly in women who use them for years before getting pregnant. No one knows how breast tissue will respond to continuous exposure to hormones, Prior points out. And she says using the pill without a break could have a detrimental effect on bone density, especially in women under 25 who are still building bone. It could be that the cumulative dose of continuous hormones amplifies these risks and benefits.
What is clear, though, is that many women and doctors are eager to embrace the idea of no more periods, which could have a big impact on the 12 million oral contraceptive users once Lybrel hits pharmacy shelves in July. "Our market surveys show that 60 percent of women are interested in putting their periods on hold with oral contraceptives, and 97 percent of gynecologists say that it's safe when used appropriately," says Amy Marren, director of clinical affairs at Wyeth. "We know it's not for every woman, but we think many will want it."