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FDA Approves Ella Drug, Pro-Life Groups Say It's Untested, Causes Abortions
- 8-16-2010
FDA Approves Ella Drug, Pro-Life Groups Say It's Untested, Causes Abortions Washington, DC (LifeNews.com) -- Billed as a better morning after pill, because it can be used longer after sexual intercourse than the traditional Plan B drug, the drug would almost always cause an abortion because it would begin working days after conception, which confers into existence a new, unique human being. Supporters of the drug have gotten around that fact by redefining the beginning of pregnancy as implantation rather than conception, or fertilization. "The prescription-only product prevents pregnancy when taken orally within 120 hours (five days) after a contraceptive failure or unprotected intercourse. It is not intended for routine use as a contraceptive," the agency said. In June, the FDA Advisory Committee for Reproductive Health Drugs Watson Pharmaceuticals Inc. will sell the abortion drug under the name ella starting in the last three months of the year. Wendy Wright, the president of Concerned Women for America led off a conference call today with reporters in advance of the decision, saying that the FDA is misleading American women. "The FDA underscored the point that this decision was driven by politics by releasing it late on a Friday when people are not paying attention," she said. The FDA advisory panel made its decision based on data from two phase III clinical trails the French drug maker HRA Pharma sponsored. 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. That's because all of the women using ulipristal during that time period had abortions. Wright pointed out how the FDA is following its decision during the latter part of the Clinton administration to approve the dangerous RU 486 abortion drug -- which has killed at least 13 women, and potentially dozens more, and injured more than 1,100 in the United States alone according to FDA reports. "Though called an 'emergency contraceptive,' the drug operates the same way as the abortion drug RU-486, which has caused numerous deaths and over 1,000 reported adverse events," she said. Wright said women could become victims again, especially because the ella abortion drug has not undergone rigorous testing and medical trials. "Adequate trials have not been done with this new drug," she said, noting that women have not been tested with the drug after use five days from intercourse even though the plan is to get women to use the drug after that time period. She noted abortion businesses are already violating the three-day time limit the FDA suggests with the morning after pill and various limits associated with the RU 486 abortion drug and she is concerned more abuses are forthcoming. "What kind of an effect does ella have on babies who survive the drug?" Wright asked. She said she is concerned about a high rate of potential birth defects for unborn children who are born after failure of the ella pill, known as EllaOne in Europe. Wright pointed out that clinics trials concerning potential birth defects were not conducted before the FDA advisory committee issued its recommendation and have not been done since then. "Incredibly, despite evidence that ella may cause birth defects in babies that survive, members of an FDA Advisory Committee recommended against long-term studies to determine if it does, preferring that women be kept in the dark," Wright said. Although the manufacturer of the drug claims it is safe for women, "The drug sponsor should prove it," she said. "Women deserve better than this. If the FDA deliberately misleads women by mislabeling the drug as a contraceptive, and does not send the drug back for adequate trials to determine the possible serious complications to women and their babies, it will be putting abortion politics above women's health," Wright concluded. "The FDA should not have lower standards for reproductive drugs for women than it would for any other drug," she said. Kristan Hawkins, the director of Students for Life of America; Jeanne Monahan, Director of the Center for Human Dignity at the Family Research Council; and David Bereit, the director of 40 Days for Life, also participated in the call. Related web sites: Comments or questions? Email us at
The FDA approved the drug with prescription-only status and Erin Gainer, the CEO of drug-maker HRA Pharma, said previously "We currently have no plans to request over-the-counter status for this drug."
"The meager trials done on ella indicate it may cause miscarriages and birth defects. Yet the FDA allowed the HRA Pharma to avoid fully testing the drug so women will be kept in the dark on what kind of serious complications it may cause to her and her baby," she added.
Ella is the first selective progesterone receptor modulator (SPRM) available in the United States for the indication of "emergency contraception (EC)." According to the European Medicines Agency, SPRMs block progesterone which is necessary to maintain a pregnancy. This effectively deprives the unborn child in the womb of the nutrients he or she needs to live.
The studies showed 1.51 percent of women using ella (or ellaOne in Europe) became pregnant when using the drug 72 hours after intercourse while 2.81 percent became pregnant when using the Plan B drug.
During the advisory committee meeting, Americans United for Life and the
Congressman: FDA-OKd Abortion Drug Ella May Be Funded in ObamaCare -
Ella Causes Abortions - http://www.ellacausesabortions.com
Copyright 2003-2010 LifeNews.com. All rights reserved. The Food and Drug Administration today approved the controversial ella drug that supporters label a morning after pill but pro-life groups point out will cause very early abortions. They say the drug is untested and women will be misinformed about how it works as an abortion agent.
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