FDA considers 5-day 'morning-after pill'
A French drug company hopes to offer American women something their European counterparts have: a pill that works long after "the morning after."
By Rob Stein
The Washington Post
WASHINGTON — A French drug company hopes to offer American women something their European counterparts have: a pill that works long after "the morning after."
The drug, dubbed ella, would be sold as a contraceptive that could prevent pregnancy for up to five days after unprotected sex.
But it is a close chemical relative of the abortion pill RU-486, raising the possibility it could theoretically be used to induce abortion by making the womb inhospitable for an embryo.
The controversy sparked by that ambiguity will force a federal advisory panel that will consider endorsing the drug next week to deal with difficult issues.
The last time the Food and Drug Administration (FDA) 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 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 unprotected sex, was eventually approved for sale without a prescription, though 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.
It is being welcomed by many U.S. advocates for family planning and reproductive rights. Opponents of the drug said the French company and the FDA would be misleading the public by labeling ella as an emergency contraceptive.
Its chemical similarity to RU-486 makes it more like the abortion pill, which can terminate a pregnancy at up to nine weeks, they say.
RU-486 has soared in popularity since approval 10 years ago in the United States, raising the possibility that ella — or ulipristal acetate — might become ubiquitous in U.S. women's medicine cabinets.
"With ulipristal, women will be enticed to buy a poorly tested abortion drug, unaware of its medical risks, under the guise that it's a morning-after pill," said Wendy Wright, of Concerned Women for America, which led the battle against Plan B.
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, making it a continuing focus of controversy.
RU-486 works by blocking progesterone's activity. Because progesterone is needed to prepare the womb to accept a fertilized egg and to nurture a developing embryo, RU-486 can prevent a fertilized egg from implanting and can dislodge growing embryos.
Its chemical similarity raises the possibility that ella — perhaps if taken at elevated doses — may do the same thing, though no one knows because the drug has never been tested that way. Opponents of the drug are convinced it will.
"It kills embryos, just like the abortion pill," said Donna Harrison, president of the American Association of Pro-Life Obstetricians and Gynecologists. "It's embryotoxic."
Critics fear that women who do not realize they are already pregnant will use the drug, unwittingly giving themselves an abortion.
They also fear some women will purposefully try to use ella to abort a fetus, putting themselves at risk for potentially life-threatening complications that have been reported among a small number of women using RU-486, and possibly damage their developing child if it doesn't work.
Proponents dismiss those concerns, saying ella has been tested only within five days of unprotected sex and there is no evidence it works as anything other than a contraceptive.
Ella appears to be about twice as effective as Plan B at preventing pregnancy, and its effectiveness remains constant for at least 120 hours. Plan B begins to lose its effectiveness almost immediately and becomes ineffective after 72 hours.
"There is a 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 ella is highly safe, producing only headaches, nausea, fatigue and other minor side effects, she said.
5-day 'morning-after pill' - Google News
H.2010.06.17 - new "5-day morning after" pill
(PhysOrg.com) -- Currently, women who seek emergency contraception within 72 hours of intercourse can receive copper intrauterine devices. Though the devices are very effective at preventing pregnancy, they must be administered by a highly trained clinician and are not universally accepted by patients, as they have a higher risk of complications than oral applications. These factors stand as deterrents to some women obtaining emergency contraception after a 3-day period.
But a novel morning-after pill that was approved last March for use in Europe has undergone new testing for safety and efficacy in the U.S. The emergency contraception, ulipristal acetate (ellaOne), for women who have had unprotected sex, claims to have enough potency to protect them from pregnancy for up to 120 hours after intercourse. The one similar pill, levonorgestrel, is already approved in the U.S., but it is effective only up to 72 hours.
Both levonorgestrel and the new medication, ulipristal acetate, are manufactured by HRA Pharma of Paris, which supported the U.S. study.
Researchers studied 1,241 women requesting emergency contraception. The women enrolled in one of 45 Planned Parenthood clinics and received one 30 mg. dose of ulipristal acetate. Follow-up was performed by urine tests (chorionic gonadotropin) and the women’s return of menses.
Results indicate that ulipristal met the statistical requirements for efficacy with a pregnancy rate of 2.1 percent (26) of the women in the study. Additionally, it was found that ulipristal did not lose its potency over the time period administered (i.e., from 48 hours to 120 hours after intercourse), unlike levonorgestrel.
Side effects of ulipristal acetate were mostly headache, nausea, and abdominal pain, but the effects were mild to moderate and resolved spontaneously, according to the researchers.
The findings are published online by the Obstetrics & Gynecology journal.