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FDA Calls New Abortion Drug Ella, Billed as Morning After Pill, Safe for Women

by Steven Ertelt | WASHINGTON, DC | LIFENEWS.COM | 6/15/10 9:00 AM

National

FDA Calls New Abortion Drug Ella, Billed as Morning After Pill, Safe for Women

by Steven Ertelt
LifeNews.com Editor
June 15
, 2010

Washington, DC (LifeNews.com) – The Food and Drug Administration today declared a new abortion drug called ella (also known as ellaOne and ulipristal) safe and effective for women. The ella pill is billed as a new morning after pill that can work longer after intercourse than the traditional morning after pill but it mostly acts as an abortion drug.

The FDA released documents today saying ella, made by French drugmaker HRA Pharma, appears to work with no unexpected side effects.

The documents come ahead of a public meeting slated for Thursday, where Obama administration officials will decide whether to market the drug, currently used in Europe, in the United States. Watson Pharmaceutical would sell the drug in the United States should the FDA approve its use.

The FDA review papers say the makers of the drug have shown it has no unexpected side effects, though normal side effects such as nausea, headache and abdominal pain were common.

"Data on pregnancy outcomes after EC (emergency contraceptive) failure with ulipristal were too limited to draw any definitive conclusions regarding the effect of ulipristal on an established pregnancy or fetal development," the FDA wrote.

Abortion advocates, aided by media reports from sources such as USA Today, have falsely portrayed the drug as a "morning after pill" and "a new emergency contraceptive" that can prevent pregnancy "five days after sex."

Yet the drug, marketed as ellaOne in Europe, is one that will almost always cause an abortion because it is designed to prevent implantation — when a unique human being days after conception attaches to the lining of the uterine wall and begins the next stage of the pregnancy process.

In other words, the drug acts as an abortion agent by destroying the life of the new person conferred at conception, or fertilization.

That’s the view of a national organization of pro-life obstetricians and gynecologists as well as a pro-life legal group — both of which have filed papers with the FDA asking the agency not to approve the drug for over the counter sales.

Americans United for Life and the American Association of Pro Life Obstetricians & Gynecologists told the FDA a study in England confirms the pro-life perspective that ulipristal acts as an abortion drug.

Anna Glasier, of NHS Lothian in Edinburgh, led a study of more than 5,500 women in the UK published online in The Lancet medical journal. It found fewer pregnancies among those women given the ellaOne drug within five days of intercourse.

And for women who took the drug between 3-5 days after having sex, only women taking the traditional morning after pill became pregnant. They’s because all of the women using ulipristal during that time period had abortions.

"AAPLOG has concluded from publicly available information that ulipristal acetate is an abortifacient of the same type as mifepristone (RU 486) and that its approval as an emergency contraceptive raises serious health and ethical issues," the letter says. "Furthermore, ulipristal’s potential effects on women who used the drug off-label and upon ongoing pregnancies are essentially unexamined and untested."

The medical literature, AAPLOG says, has established that ellaOne has the "ability to destroy established pregnancies, as well as prevent implantation."

If the Obama administration were to approve the drug "without making clear to the public that ulipristal has a substantial abortifacient capability – that action would violate the public trust granted FDA by Congress."

AAPLOG calls for the FDA to give the drug its highest black box warning if it approves it for sale because there is no way it can prevent women are who pregnant from taking the ellaOne drug.

"There is no way this can be avoided if ulipristal is approved as an emergency contraceptive; it will be par for the course. Such exposure could lead to the death of the embryo and the abortion of the woman’s pregnancy. Since ulipristal is not being approved as an abortifacient it will be necessary for FDA to include a boxed warning notifying health care providers of the drug’s abortion-producing properties," it said.

They noted the drug presents a host of safety concerns for women and that clinical trials haven’t begun to fully evaluate potential medical problems.

"The adverse events reported during the clinical trials include a profile of increased infections and bleeding disturbances not surprisingly similar to the adverse events reported for mifepristone," the doctors wrote. "The increase in infections is predictable … Yet even more disturbing are the reports of ovarian pain (common) and ovarian cyst formation in clinical trial participants. In three patients the cyst formation did not resolve; which resulted in two cases of surgery: one exploratory surgery for ruptured cysts and one surgical removal of an ovary."

In England, the ellaOne drug is sold via prescription and costs almost three times as much as the morning after pill.

Glasier told the Daily Mail she doesn’t think the Ellaone drug will become as popular because women like the convenience of getting the morning after pill at a pharmacy without the prescription Ellaone requires.

But if that changes in England or becomes available without a prescription in the United States or other countries, those pro-life fears will be confirmed.

Related web sites:
Americans United for Life – http://www.aul.org
American Association of Pro-Life Obstetricians and Gynecologists – http://www.aaplog.org

 

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