Tuesday, June 15, 2010

New 'Morning After' Pill Works Five Days Later, Too

Categories: Women's Health, Policy, Your Health, Public Health & Prevention

03:00 pm

June 11, 2010

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June 11, 2010

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Paul Fine would like to stop seeing emergency contraceptives referred to as "morning-after pills."

white pill iStockphoto.com

A new emergency contraceptive is already creating a stir.

Particularly because the new pill Fine is hoping the Food and Drug Administration will soon approve, called ulipristal, works up to five days after unprotected sex.

"Emergency contraception is a woman's last chance to prevent an unintended pregnancy," says Fine, who is medical director of Planned Parenthood of Houston and Southeast Texas. "And half of all pregnancies in the U.S. are unintended."

And unlike the leading drug now used to prevent pregnancy after the fact, called Plan B, whose effectiveness declines the longer a woman waits to take it, "ulipristal is just as effective between four and five days as it is in the first couple of days."

Which raises the question — what woman needs to wait five days before she realizes she doesn't want to get pregnant?

The answers might surprise you — and they are actually contained in the demographic data for the clinical trial for the drug that Fine and his colleagues will present to an FDA advisory committee next week.

It turns out in the study — published in the Journal of the American College of Obstetricians and Gynecologists — that most of the women who took the drug between two days and five days after unprotected sex were young, mostly  between the ages of 18 and 25. And 60 percent were white. More than two-thirds had some college or were college graduates.

Fine says he wasn't surprised by that. He says the need for emergency contraception has less to do with education and social status and more do with denial.

"Women sometimes say, 'Oh, I couldn't become pregnant from that.' ... They deny the possibility and don't really accept the reality of it. And it's not rare there's a delay of a day or two before it really sinks in [that] 'Hey, I better do something.' And with Plan B it may be too late."

Which is why the new drug is needed, he says.

But a fight is already shaping up over whether ulipristal — which will be marketed in the U.S. under the brand name "Ella" — should be approved. Abortion opponents say it not only prevents ovulation but can also destroy a fertilized egg, which they say is equivalent to abortion.

"It prevents the fertilized egg, the embryo, from implanting in the uterus. And if the embryo has already implanted, it will destroy the embryo," says Donna Harrison, president of the American Association of Pro-Life Obstetricians and Gynecologists.

Mailee Smith of Americans United for Life simply calls the drug "the next generation of RU486," the abortion pill. "So we definitely are pushing the FDA not to approve this."

Fine says that's a fundamental misunderstanding of how the drug works. "It is not an abortion drug as is being alleged. In fact in the dosage it's being used as a single pill, there's no data whatsoever that this causes abortion," he said.

In fact, he pointed, out, during the clinical trials on ulipristal, some women actually did get pregnant, because they had already ovulated by the time they took the drug. And since the drug works by preventing ovulation, it was therefore too late for the drug to work as intended.  But that does demonstrate, he says, that it does not cause abortion.

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