Late last week, the Food and Drug Administration announced the approval of a controversial new prescription pill that can prevent unplanned pregnancy for up to five days after unprotected sex. Marketed under the name "ella," the drug is a significant development in the world of so-called "morning after" pills that aim to thwart ovulation in case sexual assault, broken condoms, or simply bad judgment coincides with the time a woman's body is scheduled to send an egg down the fallopian tubes to be fertilized. Studies have found it to last longer and be twice as effective as Plan B, the version currently on the market, which is only effective for up to 72 hours after intercourse
Proponents are heralding the approval of ella, which is already available in Europe, as a welcome expansion of women's reproductive options. Known as ulipristal acetate, it's chemically similar to the abortion drug RU-486 but will be dispensed in much smaller doses and labeled as an emergency contraceptive. Critics, however, warn that it's a potentially dangerous drug that was inadequately studied. It also reignites the debate about what defines contraception and abortion.
When taken during the five-day window following intercourse, ella is estimated to reduce the risk of becoming pregnant by about two-thirds. In several studies, only 2 percent of women taking ella up to 120 hours after intercourse became pregnant, whereas researchers estimated that at least 5 percent of women not taking the pill would have become pregnant. Ella works through a progesterone blocker that delays the surge of hormones that signal the body it's time to release a mature egg. The main advantage is that a woman can take it while she's ovulating, whereas Plan B has to be taken before the surge begins—approximately 36 hours prior to ovulation—and becomes less effective the longer a woman waits to take it. Since women tend to have higher sex drives right before they ovulate and are more likely to engage in sexual intercourse, being able to take ella closer to an "oops" moment is an important benefit, explains David Archer, professor of obstetrics and gynecology as Eastern Virginia Medical School, who serves as an expert for ella's manufacturer, HRA Pharma of Paris.
But what happens if a woman has already ovulated and her egg has been fertilized before she takes ella? In a normal pregnancy, an embryo takes up to one week from conception to burrow its way into a woman's uterine lining. After the embryo is successfully implanted, a woman is considered to be pregnant, according to the medical definition. Pro-life supporters, who regard the moment when the sperm meets the egg as the beginning of life, are worried about the effect of ella on an embryo before it implants and raised similar concerns following the approval of Plan B in 1999.
At least one study of ella has noted that the drug given at high or repeated doses could alter the lining of a woman's uterus and theoretically impair an embryo's implantation. Archer says there's no evidence that ella can interrupt an existing pregnancy or prevent implantation, and other experts point to the drug's 2 percent failure rate as proof. "At that point, it's just a microscopic ball of about 256 to 550 or 600 cells that will differentiate in the future," explains Archer. "You won't see a head or fingers or any fetal organs."
Critics are also concerned about the lack of research about how ella might affect the development of an embryo of a woman who didn't know she was already pregnant when she took the drug. "RU-486 acts in the body in the same way [that ella does] and can abort a pregnancy," says Donna Harrison, president of the American Association of Pro-Life Obstetricians and Gynecologists. "This drug has not been tested in pregnant women. We know that two out of 100 women who take ella will become pregnant. That's two babies who will be exposed to this toxic drug. It's completely unethical." Dr. James Trussell, director of the Office of Population Research at Princeton, who also was a consultant for ella's manufacturer, pointed out that the handful of women who were discovered to be pregnant after taking ella didn't appear to suffer from ill effects. He adds that a woman would have to take "many, many, many times" the amount of the drug to induce an abortion. "And where is someone going to get it?"
Watson Pharmaceuticals will market ella domestically and plans to make it available in late fall. So far, it appears to be safe, and the 4,500 women involved in the studies have only reported minor side effects, including headaches, nausea, and abdominal pain. In the meantime, it needs to be studied further. The drug is an important advance that will undoubtedly be embraced by women who are grateful it can reverse the consequences of regrettable acts and unfortunate contraceptive malfunctions. They will also appreciate the extra days to contact their doctors to secure a prescription.