TUESDAY, May 22, 2007 (HealthDay News) -- Lybrel, a birth-control pill that does away with a woman's monthly period, was approved Tuesday by the U.S. Food and Drug Administration.
The estrogen-progestin hormonal pill differs from traditional birth-control pills in that it does not include the "week off" of placebo pills that leads to a cessation of artificial hormones and bleeding.
Lybrel is described as "continual contraception" but it "works the same way as the 21-days on, seven-days off [pill] cycle -- it stops the body's monthly preparation for pregnancy by lowering the production of hormones that make pregnancy possible," Dr. Daniel Shames, deputy director of the FDA's Office of Drug Evaluation III, at the Center for Drug Evaluation and Research, explained at a press conference late Tuesday.
A majority of women who decide to take Lybrel will encounter unscheduled bleeding, or spotting, that in most cases tapers off over the first year of use, Shames said. In the primary clinical trial leading up to approval, 59 percent of women who took Lybrel for one year reported no bleeding or spotting during the last month of the trial.
In terms of safety, two one-year clinical trials involving more than 2,400 18-to-49-year-old women showed no increased risk of endometrial cancer among those taking Lybrel. The risks of other side effects linked to the birth-control pill -- primarily blood clots -- were similar to those seen in other contraception regimens, Shames said.
"We don't expect any surprises in terms of long-term use of this product," he added, although he noted that the FDA has requested that the drug's maker, Wyeth Pharmaceuticals, conduct post-marketing studies to keep tabs on Lybrel's long-term safety.
Despite some women's reticence to do away completely with their monthly period, gynecologic experts agreed that there was no physiological "downside" to a period-free life. In fact, one expert noted that, for decades, many American women have been pharmaceutically ending their periods with more traditional birth-control pills with no resulting problems.
"There were other products, such as the long-acting progestin, Depo-Provera, that was given by injection," said Dr. Michael Petriella, vice chairman of obstetrics and gynecology at Hackensack University Medical Center, in Hackensack, N.J. "Women who were using that for contraception wouldn't get their period at all while on that product."
And for years, "some physicians have been allowing some women to take the Pill off-label -- allowing them to take two packages continuously, for example," Petriella said.
Another expert noted that the "period" women get while on conventional birth-control pills isn't connected to a natural cycle of egg production, anyway.
"It's not a natural period. It's an artificially induced period that happens because she stops taking the hormones for seven days. So, she gets some vaginal bleeding," explained Dr. Camelia Davtyan, an internist specializing in women's health and an associate professor of medicine at the University of California, Los Angeles.
In fact, a no-period pill like Lybrel could have been a contraceptive norm for women from the get-go, Davtyan said. However, the doctors and pharmaceutical companies who developed the birth-control pill back in the 1960s assumed that women would want a regimen that mimicked the monthly cycle.
"I guess they were trying to make it seem as 'real' as possible and cause as little change as possible in a woman's life," Davtyan said.
But times have changed, and newer contraceptive products such as Seasonale -- a contraceptive pill that cuts the number of periods to just four a year -- have already been readily embraced by some American women over the past decade.
Davtyan said she has recently noticed a big shift in her patients' attitudes toward their period.
"They want convenience, and they tell me that they'd just rather not have the bleeding altogether so that they don't have any limitations with sports, with having to use pads, tampons," she said. "And the younger the woman, the more likely that she will want her periods stopped. It's very possible that this will be the wave of the future."
But Petriella said many women still feel a strong psychological attachment to their period and do not want to give it up, however inconvenient it may be.
"Sometimes [ending periods] is just emotionally uncomfortable for women," he said. "They don't feel right about not having their period. For those women, obviously Lybrel and other such products are not good products for them."
Petriella believes that, at least in the short-term, Lybrel will appeal to only a minority of women. They include those with menstruation-linked conditions such as endometriosis and menstrual migraine, or those who have already tried -- and liked -- period-limiting products such as Seasonale, he said.
As with any pharmaceutical contraceptives, women who decide to go on Lybrel may experience random breakthrough bleeding, Davtyan said.
So, for the 59 percent of women who have no bleeding or spotting after one year, "I think Lybrel is a great deal," Davtyan said. "For the remainder, if they have the patience to hang in there for a few months, the spotting might abate. There will be an occasional patient that will continue to spot, and then, clearly, it's a better deal to have a scheduled period than to start spotting at an unknown time and maybe in an uncomfortable circumstance."
Women who decide to resume their monthly cycle -- for example, those who wish to become pregnant -- can typically expect to resume their normal cycle within days of stopping Lybrel, Shames said. He said that short timespan to resumption of ovulation could leave women who skip or miss pills open to unplanned pregnancy, so the FDA is advising that women consider a second form of birth control while on Lybrel, as a safeguard.
Both Davtyan and Petriella stressed that young women who are considering a pharmaceutical end to their period should not be concerned that doing so will harm their health.
"Remember, there's no real physiological value to hold on to the period that a woman has while she is taking the Pill, unless it is a psychological value, which I respect," Davtyan said.
There's more on various forms of birth control at the U.S. Food and Drug Administration.