At EmpowHer, we get so many questions from women who had unprotected sex and are worried about whether it might have caused a pregnancy. Some have dealt with condoms that broke; others say they didn’t intend to have sex but that things “got a little out of hand.” Some are completely freaked out – including young women as young as 15 and 16.
Up until now, “morning-after” birth control pills need to be taken within 72 hours of the unprotected sex to be effective. That means within three days.
But on Tuesday, documents released by the Food and Drug Administration say a new morning-after birth control (sold under the name ella in Europe) is effective when taken as many as five days after unprotected sex.
A public meeting is scheduled about the drug on Thursday, at which experts will decide whether to recommend making the drug available in the United States.
From Reuters:
“Women's health advocates have welcomed the potential for another emergency contraceptive option, but some critics contend the drug is more akin to the abortion pill, sold by Danco Laboratories as Mifeprex and also known as RU-486 or mifepristone.
“HRA Pharma has said its drug, whose scientific name is ulipristal, works by preventing ovulation of a woman's egg.
“In their review, FDA staff scientists said the company's studies showed no unexpected side effects in women, although reports of nausea, headache and abdominal pain were common. It was not clear what effect the drug had, if any, when a woman still became pregnant despite taking it, they added.”
From the Washington Post:
“The last time the Food and Drug Administration vetted an emergency contraceptive -- Plan B, the so-called morning-after pill -- the decision was mired in debate over such fundamental questions as when life begins and the distinction between preventing and terminating a pregnancy. Ella is raising many of those same politically charged questions -- but more sharply, testing the Obama administration's pledge to keep ideology from influencing scientific decisions.
“Plan B, which works for up to 72 hours after sex, was eventually approved for sale without a prescription, although a doctor's order is required for girls younger than 17. The new drug promises to extend that period to at least 120 hours. Approved in Europe last year, ella is available as an emergency contraceptive in at least 22 countries.
“Plan B prevents a pregnancy by administering high doses of a hormone that mimics progesterone. It works primarily by inhibiting the ovaries from producing eggs. Critics argue it can also prevent a fertilized egg from implanting in the womb, which some consider equivalent to an abortion.
“Ella works as a contraceptive by blocking progesterone's activity, which delays the ovaries from producing an egg. RU-486, too, blocks the action of progesterone, which is also needed to prepare the womb to accept a fertilized egg and to nurture a developing embryo. That's how RU-486 can prevent a fertilized egg from implanting and dislodge growing embryos. Ella's chemical similarity raises the possibility that it might do the same thing, perhaps if taken at elevated doses. But no one knows for sure because the drug has never been tested that way.
"There is an great unmet need out there for emergency contraception that is effective as this for so long," said Erin Gainer, chief executive of HRA Pharma of Paris. Studies involving more than 4,500 women in the United States and Europe show that ella is safe, producing minor side effects including headaches, nausea and fatigue, she said.
The Reuters story:
http://www.reuters.com/article/idUSTRE65E2DD20100615
The Washington Post story:
http://www.washingtonpost.com/wp-dyn/content/article/2010/06/11/AR2010061103522.html