LONDON, March 13, 2014 (LifeSiteNews.com) – The London-based European Medicines Agency is recommending that the abortifacient morning-after pill, brand named “EllaOne,” should be made available over-the-counter in the last three EU countries – Germany, Poland, and Italy – where a doctor's prescription is still needed to get the dangerous drug.
According to a Deutsche Welle report the European Medicines Agency (EMA) claims that it has the authority to decide for the whole of Europe whether a prescription is required for a particular brand of drug.
While the EMA and German “family planning” organizations downplay the hazards of the drugs used in morning after pills, and of their abortion-causing effects, German doctors' organizations are opposed to freely dispensing the medicines without proper consultation.
Daphne Hahn, head of Pro Familia, Germany's main sexual and reproductive health organization and part of International Planned Parenthood, said over-the-counter availability of the drug would benefit women since “most emergencies happen over the weekend or on public holidays.” She told Deutsche Welle that modern birth control is 100 percent safe.
However, Christian Albring, president of Germany's gynecologists' association, warned that a consultation with a doctor is vitally important because the morning-after pill is not suitable for every woman, citing concern for women also taking anti-depressants or medication for epilepsy, and noting that recent research has found that the pills are not even effective for overweight women.
“A consultation should not be carried out by anyone other than a gynecologist or a doctor on call,” Albring told Deutsche Welle.
Moreover, the president of the German Medical Association, Frank Ulrich Montgomery, warned that making the morning-after pill available over the counter ignores the potential of harm to women from seriously adverse side effects.
In a newspaper interview he stressed the importance of only prescribing the pill after a doctor's consultation and stated that it is “imperative” for the pills to only be available at pharmacies.
“The morning-after pill remains emergency medication with side effects,” Montgomery said.
Pro-life advocates have raised the alarm over the safety and testing of the drug used in “EllaOne,” saying it is little more than a chemical abortion drug similar to RU-486, remarketed to the public as contraception.
The chemical name for the drug in Ella is ulipristal acetate, which functions as a progestin-blocker, or “selective progesterone receptor modulator (SPRM).”
Other types of emergency contraception drugs work by releasing massive amounts of progesterone into a woman's body, thereby suppressing ovulation, inhibiting sperm migration and reducing sperm capacity for fertilization. This can also have an abortifacient effect if the influx of progesterone changes the lining of the womb, preventing an already conceived embryo from implanting.
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Ulipristal acetate works differently, with far more effective abortifacient results. As a SPRM, it turns off the progesterone receptors in the body crucial not only for the beginning of pregnancy, but for its continuance.
When the US FDA approved Ella in 2010 it allowed the drug to be marketed as an “occasional” emergency contraception, to be taken by a woman up to five days after sexual intercourse.
The FDA warned, however, that it was unsafe for women to use Ella more than occasionally, as they had no data on its safety over the long term.
They also warned that women should be ruled out as pregnant before being prescribed Ella, and women experiencing lower abdominal pain or who become pregnant after taking the drug should be checked by their health care providers for ectopic pregnancy.
Mifeprostone, the drug taken in the two-step RU-486 chemical abortion regimen, is also a SPRM.
Mifeprostone has been found to have had thousands of “adverse event reports” related to its use. Since the FDA approved it for sale in 2000, Mifepristone has been tied to 13 confirmed deaths, 9 of which were reported in the U.S. As of May 2006, when the FDA began reporting cases of women suffering from adverse effects of RU-486, 1,070 events were recorded, including six deaths, 9 life-threatening incidents, 232 hospitalizations, 116 blood transfusions, and 88 cases of infection.
“Make no mistake about it, Ella is a dangerous abortion drug,” said Kristan Hawkins, executive director of Students for Life of America, in a 2010 statement calling upon the FDA to review and reverse its decision. “The FDA’s approval of Ella for sale within the U.S. shows that the FDA has not done its job protecting women, particularly young women whom SFLA serves on a daily basis.”
Wendy Wright, former president of Concerned Women for America, slammed the FDA's approval of the drug as an example of holding reproductive drugs to a lower standard than other drugs, and “treating serious complications and even death as preferable to pregnancy.”
“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,” Wright said.
Contact:
Executive Director
European Medicines Agency
7 Westferry Circus
Canary Wharf
LONDON E14 4HB UK
Phone: +44 (0)20 7418 8400
Fax: +44 (0)20 7418 8416
Email: via website