A drug touted as the "next generation" in emergency contraception actually causes abortion, pro-life groups say.
In August, the Food and Drug Administration approved the drug called ella for emergency contraception, but during experimental stages, this drug caused abortions in all of the rats it was tested on and half of the rabbits, according to the FDA and the drug's labeling.
Further, of the six women who took the drug in clinical trials and had live births, one of the babies had optic nerve hypoplasia and developmental delay, according to the FDA.
The prescription drug – meant to prevent pregnancy if taken five days or 120 hours after unprotected sex or "contraceptive failure," is "not intended for routine use as a contraceptive," according to an FDA news release after the Aug. 13 approval.
Ella will be available on the market in the last quarter of 2010, beginning in October, according to manufacturer Watson Pharmaceuticals. It has been available in Europe since May 2009 under the brand name ellaOne, according to the FDA.
A coalition of 20 pro-life groups first sought to block FDA approval of the drug. Now these groups are working to inform pharmacists and the public of the possible dangers both to women and babies they are carrying. They started a website called ellacausesabortions.com.
"The goal is to continue educating the public," Jeanne Monahan, director of the Center for Human Dignity at the Family Research Council. "We believe women have the right to informed consent. Women deserve the right to know the difference between preventing life and destroying life."
The drug's manufacturer respects the concerns, a company executive said Monday, but he added there is a need to help women prevent unintended pregnancies.
"Watson believes that there remains an unmet need for a 'next generation' emergency contraceptive product and we are committed to working with women, healthcare providers, physicians and pharmacists to educate them about the availability of the ella emergency contraceptive option," Watson Senior Vice President of Corporate Affairs Charlie Mayr told CNSNews.com in a written response to questions.
Though not responding directly to questions about clinical trials and experiments on animals, the Watson statement from Mayr addressed the need for patients to consult doctors.
"As with any prescription drug, Watson encourages consumers to review patient information material, and to ask their physician or pharmacist any questions about the product and its use," Mayr told CNSNews.com.
"However, we believe the product labeling as approved clearly defines the indication for ella, provides information on the mechanism of action of ulipristal acetate, and provides complete details of the responsible use of ella as an emergency contraceptive," Mayr added.
The drug marketed as ella, known as Ulipristal Acetate, is a selective progesterone receptor modulator (SPRM) similar to the abortion drug RU-486. An SPRM starves the unborn baby of nutrients it needs to survive.
"No ectopic pregnancies were observed, although the number of pregnancies was too limited to draw any meaningful conclusions about the risk of ectopic pregnancy if ulipristal is not effective," according to a June 17 FDA document.
That same FDA report said in the clinical trials, "6 subjects (6.5%) had live births: one infant had optic nerve hypoplasia and developmental delay; the remaining 5 infants were reported as normal."
Meanwhile, the labeling of the drug will include information about experiments on animals, according to the FDA.
"Ulipristal acetate was administered repeatedly to pregnant rats and rabbits during the period of organogenesis Embryofetal loss was noted in all pregnant rats and in half of the pregnant rabbits following 12 and 13 days of dosing, at daily drug exposures 1/3 and ½ the human exposure, respectively, based on body surface area (mg/m2). There were no malformations of the surviving fetuses in these studies," the ella labeling says.
The labeling also states that women who are pregnant or who are breastfeeding should not use ella.
Further study should explore whether ella is safe for women, Monahan said, referring to numerous adverse health problems caused by RU-486, which has a similar chemical makeup with ella. RU-486 problems have included severe bleeding, ruptured tubal pregnancies, serious infections and even death.
"We would expect similar health effects," Monahan said.
The FDA news release says that clinical trials only showed side effects including headache, nausea, abdominal pain/discomfort during menstruation, fatigue and dizziness. Watson had 2,600 women in the clinical trials, according to a news release on Aug. 13 after the FDA announced the approval.
Leading pro-abortion group Planned Parenthood applauded the approval of ella.
"Given the fact that half of all pregnancies in the U.S. are unintended, it is vital that women have an array of choices available to prevent unplanned pregnancy," Planned Parenthood President Sarah Stoesz said in a statement. "Ella will become an important option for women."
Contact: Fred Lucas
Date Published: September 21, 2010
