By Rob Stein
Washington Post Staff Writer
Wednesday, May 23, 2007
The Food and Drug Administration yesterday approved the first birth control pill that eliminates a woman's monthly period.
Taken daily, the contraceptive, called Lybrel, continuously administers slightly lower doses of the same hormones in many standard birth control pills to suppress menstruation. It is designed for women who find their periods too painful, unpleasant or inconvenient and want to be free of them.
"This will be the first and only oral contraceptive designed to be taken 365 days a year, allowing women to put their periods on hold," said Amy Marren of Wyeth Pharmaceuticals, which expects Lybrel to be available with a prescription by July. "There are a lot of women who think that's a great option to have."
Company studies involving more than 2,400 women showed that Lybrel is as effective at preventing pregnancy as standard birth control pills and that it completely suppresses menstruation for many women within the first year, although some experience sporadic bleeding, the FDA said.
Advocates of birth control welcomed Lybrel, saying it provides women with another option.
"Every woman's birth control needs are different, and the best methods are those that fit a woman's lifestyle and meet her needs," said Vanessa Cullins, vice president for medical affairs at the Planned Parenthood Federation of America.
But others questioned whether enough research had been done to be sure that Lybrel is safe to suppress menstruation in the long term.
"There may be important health consequences that we don't know about," said Christine L. Hitchcock, an endocrinology researcher at the University of British Columbia. "I don't think we understand everything that the menstrual cycle does well enough to say with confidence that you can abolish it and not have any consequences."
Some criticized Lybrel for fueling biases and misconceptions about menstruation.
"I think it sends the wrong message about menstruation in women's lives, especially for young women," said Ingrid Johnston-Robledo, an associate professor of psychology and women's studies at the State University of New York at Fredonia. "It perpetuates a lot of negative attitudes and taboos about menstruation -- that it's something that's bothersome and dirty and debilitating and shameful."
Wyeth and the FDA said that there is no evidence of any long-term risks and that suppressing the menstrual cycle can have many benefits, especially for women who experience cramps, bloating and mood swings. There is no reason to think it would pose any additional health hazards, they said.
"The risks of using Lybrel are similar to other conventional oral contraceptives," said Daniel Shames, deputy director of the FDA's Center for Drug Evaluation and Research. "We don't suspect there are going to be any surprises in terms of long-term use of this product."
Rosa Nolasco, 38, of New York said Lybrel liberated her from the monthly torment of her period when she took it as part of a clinical trial.
"I get really severe cramps, bloating, chocolate cravings, mood swings. I would literally be in bed for a few days each month," said Nolasco, a single mother of four. "It was really nice not to have to worry about any of that."
Others said menstrual suppression could have some health benefits. For eons, women had few periods because they were either pregnant or breast-feeding for most of their reproductive years.
"We weren't supposed to have 13 natural periods year after year after year," said Linda Miller, an obstetrician-gynecologist at the University of Washington in Seattle. "We as a society have already changed what nature intended for us."
But she said that women can accomplish the same goal more inexpensively by using generic versions of some birth control pills that have long been available.
"You don't need a brand," said Miller, who counsels women about suppressing their periods through her Web site, NoPeriod.com.
Standard oral contraceptives consist of 21 pills containing the hormones estrogen and progestin, which prevent ovulation, followed by seven dummy pills that allow menstruation. The birth control pill was originally developed to mimic a normal cycle in the belief that women would find it more acceptable, not because it would be safer or more effective at preventing pregnancy.
The FDA approved a birth control pill formulation known as Seasonale in 2003, and a similar regimen called Seasonique in 2006, both of which reduce the number of periods to four times a year.
Amy Alina of the National Women's Health Network, a Washington advocacy group, said Lybrel could offer an attractive alternative for some women. But she said she is concerned that the company is playing down the number of women who still experience bleeding while taking Lybrel.
"You still have bleeding, but you just don't know when it's going to happen," she said.
In the company's research, Lybrel eliminated bleeding in the 59 percent of women who took it for a full year. But many women stopped early, in part because they continued to experience bleeding and spotting.
Because women taking Lybrel may not know whether they are pregnant, the FDA said that they should undergo pregnancy tests if they suspect they could be. Ovulation can begin within days of discontinuing the pills.
Wyeth has not yet set a price for Lybrel.