On June 17th, an advisory panel of the Food and Drug Administration (FDA) made a recommendation that the FDA should approve EllaOne (Ulipristal), a new drug closely related to Mifiprex (Mifepristone, the RU-486 abortion pill). Like Mifiprex, EllaOne has the potential to cause the death and abortion of an established pregnancy growing in the womb. Care Net, a national network of more than 1,100 pregnancy resource centers, strongly recommends that EllaOne not be granted FDA approval. Its ability to destroy established pregnancies, as well as prevent implantation, makes it an embryocidal drug. FDA approval without making this clear to the public would violate the public trust.
HRA Pharma, the company that manufactures EllaOne, claims that it is not an abortion pill. Care Net joins other life-affirming organizations, such as American Association of Pro-Life Obstetricians and Gynecologists (AAPLOG), who have clearly stated that EllaOne is an abortifacient of the same type as Mifepristone and its approval as an emergency contraceptive raises serious health and ethical issues.
Care Net issued the following concerns regarding approval of EllaOne as an emergency contraceptive:
1. EllaOne can cause the death of an embryo growing in the uterus. Women seeking pregnancy "prevention" need to be adequately informed of this potential - the FDA should include a "Black Box" warning.
2. There is an unknown impact on existing pregnancies exposed to the drug. Women who do not know they are pregnant will take EllaOne, and there are inadequate studies on toxicity to the developing embryo.
3. Off-label use includes the potential to induce an abortion. As with Mifiprex and Plan B, this drug will no doubt be used in a manner that is outside FDA approval. The potential exists for it to be used to abort pregnancies.
4. Taking EllaOne multiple times during a menstrual cycle carries unknown safety risks.
5. EllaOne is unstudied among:
· Women over age 35
· Women who are on concomitant hormonal contraceptives
· Lactating women
· Adolescent females
6. Potential for criminal abuse of drug. EllaOne could be used on an unsuspecting, pregnant woman. FDA needs to put in place proper restrictions to prevent this abuse.