WASHINGTON, D.C. – (8/13/10) – “The FDA’s irresponsible approval of ella (Ulipristal), without adequate safety studies, places women’s health and lives at risk,” said Dr. Charmaine Yoest, President and CEO of Americans United for Life. “Furthermore, billing this abortion-causing drug as an ’emergency contraceptive’ is misleading to the public.”
The drug ella is being marketed as an “emergency contraceptive,” but it is the “next generation” of the abortion drug, RU-486. Like RU-486, ella is a selective progesterone receptor modulator (SPRM).
As a progesterone blocker, an SPRM works to interfere with the developing human embryo, causing it to die by either interfering with the uterine lining and preventing implantation, or by starving an implanted embryo. Women deserve to be fully informed that ella may interfere with and kill a developing embryo and does not only prevent conception.
In June, several members of the FDA advisory panel that reviewed ella’s application raised the concern that there was insufficient data to show the effect ella would have on a pregnancy and a developing embryo or fetus.
However, at the end of the meeting, the panel inexplicably voted unanimously in favor of approving the drug as a contraceptive, and specifically recommended that the FDA not require a pregnancy test before dispensing ella.
Serious concerns also exist about ella’s risk to women’s health.
The chemical make-up and mechanism of action of ella are very similar to RU-486, which is known to cause serious adverse health risks such as severe bleeding, ruptured tubal pregnancies, serious infections, and even death.
Further study is necessary to ensure ella is safe for women, particularly if it is used off-label.
The FDA summary also indicates that the clinical study on ella was too limited to draw any meaningful conclusions about risks associated with tubal pregnancy. Little data is available about ella’s effect on minors or complications from ella’s interaction with other drugs, such as hormonal birth control.
Americans United for Life is part of a coalition, ella Causes Abortions, and joined in signing a letter to the Commissioner of the FDA, urging the agency not to approve ella.