- The Washington Times - Wednesday, May 23, 2007

The first birth-control pill that allows women to suppress their monthly menstrual cycle, and skip periods, was approved by the Food and Drug Administration yesterday.

The pill, called Lybrel, a name its maker, Wyeth Pharmaceuticals, intends to symbolize “liberty,” is unlike other prescription birth-control pills that include placebos and have been standard since the sales began in the 1960s.

Lybrel is taken 365 days a year, rather than the typical 21-day regimen followed by a seven-day series of placebo pills, the combination that causes a mild, artificial period.

The drug contains the lowest dose of two hormones widely used in birth-control pills, ethinyl estradiol and levonorgestrel.

After specifically looking for cancer and other side effects as a result of suppressing the menstruation cycle, the FDA determined the drug is as safe as other oral contraceptives. The most significant risk is cardiovascular problems in women who smoke, which is why the pills are packaged with a warning not to smoke.

“We don’t expect any surprises down the road,” said Daniel Shames, deputy director of the FDA’s Office of Drug Evaluation, adding that to ensure safety the FDA requested that Wyeth conduct further studies once the drug has been put on the market.

Avoiding monthly periods is not a new practice for women taking birth-control pills; however, because Lybrel is designed to be taken continuously all year, periodic bleeding will all but be eliminated, according to Wyeth. FDA officials say some surprise bleeding or spotting is likely to occur.

“This pill is not for all women,” said Natalie de Vane, spokeswoman for Wyeth Pharmaceuticals. “It is intended for women who want a choice of whether to have their period or not. There are women who want that lifestyle option; for women who do not, it is probably not for them.”

Clinical tests of Lybrel showed that 59 percent of women ended up with no bleeding after six months, but 18 percent of women dropped out of studies because of spotting and breakthrough bleeding, according to Wyeth.

The demand for Lybrel, which will begin being sold in a 28-day pill pack in July to doctors, is presumed to be high as industry analysts estimate sales could reach $40 million this year and $235 million by 2010. Wyeth has not disclosed how much Lybrel will cost.

A similar birth-control drug, Seasonique, made by Barr Pharmaceuticals, which entered the market in August, reached $6.1 million in sales in the first quarter of 2007, while its predecessor Seasonale, which allowed for a woman to have a period once every three months, peaked at about $120 million.

Women’s health specialists are welcoming the advent of Lybrel as a new option for women who prefer to bypass their menstrual cycle.

“It will be accepted by women, but the age and stage of life at which women will take it will be interesting to watch,” said Elizabeth Cahill, executive vice president of the National Women’s Health Resource Center. “This pill will probably be used more by women in their 20s who are very busy traveling and working. Older women who have already had children may want their period to know they’re not pregnant.”

Eleanor Smeal, president of the Feminist Majority Foundation, said this type of birth-control pill is long overdue and will be widely used by women with health problems such as endometriosis and severe cramps.

“We think this option was available a long time ago and should have been offered from the 1960s when the pill was first introduced,” she said. “It is about time.”

Lybrel is 98 percent effective at preventing pregnancy, but because a woman taking the drug will likely not experience a period, determining a pregnancy presents a dilemma.

“That is a concern,” Ms. de Vane said. “We encourage women taking Lybrel who think they might be pregnant to take a pregnancy test.”

In an effort to raise awareness about menstrual suppression, the Society for Menstrual Cycle Research held a panel in 2003 to discuss the issue. One group of researchers on the panel concluded that there was not enough evidence to suggest that menstrual suppression is entirely safe and reversible.

“While we recognize that menstrual suppression may be a useful option for women with severe menstrual-cycle problems such as endometriosis, we do not believe that continuous oral contraceptive use should be prescribed to all menstruating women out of a rejection of a normal, healthy menstrual cycle.”

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