FDA Approves Period-Stopping Pill

May 22, 2007 — -- A drug approved by the Food and Drug Administration promises to be the first of its kind to make "that time of the month" a thing of the past.

This afternoon, the FDA approved Wyeth Pharmaceuticals' Lybrel as the first continuous-use drug for the prevention of pregnancy. Its intended use is as a birth control measure, but it also has the side effect of halting women's periods indefinitely.

While Lybrel is the first drug approved to halt menstrual bleeding for good, "we have used birth control pills in the off-label fashion for a long time," said Alison Edelman, a researcher at Oregon Health and Sciences University, who has studied birth control. "I think a lot of women are already doing this on their own."

New Pill, Old Practice

Even though Lybrel is approved for everyday use, it is simply an adjustment of the same formulations of estrogen and progestin used in birth control pills for decades, according to several leading doctors.

Edelman said that Lybrel's approval would likely lead to wider legitimacy for a practice already going on — a step some women regard as essential.

Shannon Eley, 30, of Harrison, Ohio, has taken oral contraceptives since she was 13 because she suffers from endometriosis, a condition in which uterine tissue grows elsewhere in the abdominal cavity, resulting in excessive bleeding and pain during the menstrual cycle.

Eley sees Lybrel as a great alternative, as even birth control regimens that limited her cycle to four times a year were painful and still resulted in a great deal of bleeding.

"I would love to try it so that I don't have to have a period," she said. The only cure for endometriosis is a complete hysterectomy. I'm too young for that."

Her physician, Eley said, did not prescribe taking oral contraceptive drugs every day — a practice not FDA-approved before today.

Near Unanimous Support Among Doctors

But while some question the safety of avoiding periods, doctors in the field appear nearly unanimous in supporting the safety of Lybrel.

"You've already thwarted nature," said Dr. Leslie Miller, an associate professor of women's health at the University of Washington School of Medicine. "The menstrual cycle's purpose is ovulation" — a process halted by use of any birth control pills.

The bleeding, said Miller, is simply a side effect of the menstrual cycle.

When birth control pills were first designed in the 1950s, physicians felt they might gain wider acceptance if they mimicked a woman's natural cycle. For 21 days, the pills would block ovulation; then, when the oral contraceptives were stopped for seven days and replaced with sugar pills, the uterine lining would be shed, causing menstrual bleeding.

Lybrel takes the dosage and the process a step further.

"With this type of pill ... the lining of the uterus stops growing and, in fact, goes into hibernation," said Dr. Bob Barbieri, head of obstetrics and gynecology at Brigham and Women's Hospital in Boston. "For those women who don't want to have their period, and for those who have a specific symptom ... this is a good option."

Barbieri said that, early on, most women would probably still prefer to have periods, although that number would decline as not having periods gained more widespread acceptance.

Questions Remain

Some fear that acceptance could turn to pressure.

"If you're taking this product because you're looking for convenience, that's actually going in the wrong direction," said Amy Allina, program director of the National Women's Health Network, in an interview with ABC's "World News."

She said that while this pill might lead women to think there is something wrong with having a period, women on Lybrel would often experience bleeding when they're not expecting it.

Miller feels Lybrel is safe but has raised several questions about Lybrel's approval.

While nearly 80 percent of women were no longer "bleeding," Miller pointed out that less than 60 percent of the women involved had their menstrual blood flow stop completely. The difference was that some of the women experienced "spotting" — slight bleeding, which occurred irregularly, although it was slight enough that the women did not require a pad or tampon.

"If the goal is 'not blood,' they still need to improve it," she said. "The problem is that it doesn't necessarily deliver no periods for all women who take it."

Miller also pointed to the fact that 19 women became pregnant while on Lybrel, with only four of those failures attributed to mistakes by the users, and the rest attributed to "method." She speculated that this might have delayed Lybrel's approval.

Lybrel's failures, Miller said, might be due to the fact that it is a reduced dose of treatments than were used in the past. That, coupled with the increased average weight of the American woman, could lead to the drug's occasional ineffectiveness.

To combat that issue, Miller said, birth control pills should focus less on branding and more on adjusting doses to allow adjustments for weight.

"Not every dose is going to fit every woman," Miller said.

Simply making adjustments to the levels of progestin and estrogen in doses would be ideal for women, said Miller, who questions why Wyeth can't market a drug that simply adjusted those levels.

"I'm really surprised they got a patent," she said.

Miller also questioned the dropout rate in the study. Of the 2,134 subjects who began the study, more than half did not complete it — a rate Miller said is unusually high.

Wyeth did not respond to calls seeking comment.

Miller said that one potential problem may arise from women who carry excess iron in their blood, a condition known as hemochromatosis. Without menstrual bleeding, she said, females might develop it at a higher rate.

But despite her reservations, Miller still believes that women stand to benefit from Lybrel's introduction, since studies have shown that not having a period isn't inherently unsafe.

"It's nice that the conversation is happening," she said. "It's nice for the world to recognize you don't need a fake period."

ABC News medical correspondent Brian Hartman and Dr. Supinda Bunyavanich contributed to this report.