Pro-Life Doctors tell FDA Not to Approve New Abortion Drug EllaOne for Sale

National   |   Steven Ertelt   |   Jun 3, 2010   |   9:00AM   |   WASHINGTON, DC

Pro-Life Doctors tell FDA Not to Approve New Abortion Drug EllaOne for Sale

by Steven Ertelt
LifeNews.com Editor
June 3
, 2010

Washington, DC (LifeNews.com) — A national organization for pro-life physicians has sent a letter to the Food and Drug Administration urging officials to not approve the abortion drug ellaOne. Abortion advocates bill the drug as a new form of the morning after pill, but it works as an abortion agent by destroying the life of a unique human being.

The abortion drug, also known as ulipristal (but different from the more commonly known RU 486 or mifepristone) is said to be a more powerful version of the Plan B drug.

Backers claim it is able to prevent pregnancy days after conception, the drug only works as an abortion agent because conception will have already taken place.

The letter is the second to the FDA opposing approval of the drug — following one from Americans United for Life.

In the FDA letter provided to LifeNews.com by American Association of Pro Life Obstetricians & Gynecologists (AAPLOG), the doctors tell the agency that it represents more than 2,000 physicians across the country who oppose ellaOne.

"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."

Although the abortion drug has been approved in Europe for a one-time use per menstrual cycle, "the safety of predictable multiple uses per cycle has not been established."

"Thus the current NDA for Ulipristal approval in the U.S. must be considered deficient until such basic safety studies under situations of multiple use are submitted," it said.

"AAPLOG does not believe ulipristal should be approved for use in the United
States because it will act as an abortifacient in many of the women for whom it will be prescribed," the group concluded. "Since FDA appears to be determined to approve this abortifacient as a contraceptive, FDA must place restrictions on its distribution and marketing."

Related web sites:
American Association of Pro-Life Obstetricians and Gynecologists – https://www.aaplog.org

 

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