‘No More Period’ Pill Given OK by FDA: Reactions Mixed

Drug-maker Wyeth gets approval from the FDA for Lybrel, the first-ever birth control pill meant to be taken continuously to eliminate the monthly menstrual cycle.
‘No More Period’ Pill Given OK by FDA: Reactions Mixed
By Anastacia Mott Austin

Tuesday the FDA approved the use of Lybrel, Wyeth’s new birth control pill designed to eliminate a woman’s monthly period. The pill comes packaged in a 28-day dosage similar to other birth control pills on the market, but has a full month’s supply of progestin, ethinyl estradiol, and levonorgestral, without the seven-day course of placebo pills meant to mimic a period.

Though some women have been using their birth control pills off-label in this manner for years by skipping the placebo pills and continuously taking the hormones, this is the first such pill okayed for continuous use by the FDA.

The idea of women going without their monthly cycles, potentially indefinitely, was met with mixed reactions in the women’s health community.

"Women who have been presented with the option of extended hormonal use opt for [it] and like it – it’s turning out to be fairly popular," Vanessa Cullins, vice president for medical affairs at Planned Parenthood, told reporters.

Jean Elson, a medical and gender sociologist at the University of New Hampshire, disagrees. "Menstrual manipulation appears to be another in a long line of attempts to medicalize women’s natural biological life events…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?" Elson asked.

"If you think you don’t want to go down this road, this is not for you," said Dr. Daniel Shames, a deputy director for the FDA, to The Associated Press. Dr. Shames explained that of the study group of 2,400 women aged 18 to 49, almost half dropped out of the study before it could be completed, mostly because of irregular bleeding. "Women who use Lybrel would not have a scheduled menstrual period, but will most likely have unplanned, breakthrough, unscheduled bleeding or spotting," added Shames. This side effect could be expected to last through the first year of use, and is comparable to other low-dose birth control pills.

The risks of Lybrel are also similar to other pills on the market, such as blood clots, heart attacks, and strokes.

"I would totally take it. I see my period as more of a hassle than anything else," Lizzy Holmgren, 21, told ABC News. "Women are the primary caretakers because society has made it okay for us. That’s sociological, not biological. There are lots of women who don’t get periods…It’s not a deciding factor in how I view myself." Holmgren added that she feels women get judged by men in the workplace for having mood swings and taking more sick days due to their periods. "Maybe men would respect women more if they didn’t have periods."

Others took exception to this view. "I think it sends the wrong message about menstruation in women’s lives, especially for young women," said Ingrid Johnston-Robledo, an assistant professor of psychology and women's studies at the State University of New York at Fredonia, to the press. "It perpetuates a lot of negative attitudes and taboos about menstruation -- that it's something that's bothersome and dirty and debilitating and shameful."

One additional factor to consider in taking Lybrel, say medical experts, is that without any monthly bleeding it can be difficult for women to determine if they may be pregnant. Low-dose birth control pills have higher contraceptive failure rates than regular-dose pills.

While the majority of women taking the pill are doing so to prevent pregnancy, some women take birth control pills to relieve debilitating symptoms of monthly periods. For these women, experts agree, taking Lybrel could be beneficial.

Lybrel is due to hit the market in July of this year.

By Buzzle Staff and Agencies
Published: 5/23/2007
 
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