Concerns with emergency contraceptive ella

On August 13, 2010, the Food and Drug Administration approved a new drug called “ella” (also known as ulipristal acetate) for use as a emergency contraceptive. Women will need to get a prescription before obtaining ella. This drug has been used in Europe since 2009.

The FDA’s web site (1) describes ella as a “progesterone agonist/antagonist emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure.”

Various prolife groups (2) are concerned ella doesn’t act solely by preventing ovulation but also acts by preventing a human embryo from implanting in a woman’s womb. Prolife groups have serious reason for concern because the chemical make-up of ella is similar to chemical composition of the abortion drug RU-486, which is also an anti-progesterone drug and can be used for abortions. RU-486 acts by cutting off the nutrients to the growing unborn child.

Progesterone is needed for a woman to produce and release an egg but it is also needed to prepare the womb’s endometrium lining to receive a developing child. The FDA web site notes that “the likely primary mechanism of action of (ella) for emergency contraception is therefore inhibition or delay of ovulation; however, alterations to the endometrium that may affect implantation may also contribute to efficacy.” The FDA reports that taking ella after the woman has already ovulated does reduce the thickness of the endometrium. There is not adequate data to show whether this prevents a developing child from implanting in the womb.

Some studies have shown that ella can reduce the chance of becoming pregnant by 2/3 if taken within 120 hours (5 days) of sexual intercourse. A previously approved emergency contraceptive known as Plan B is less effective and shown to be ineffective if taken more than 3 days after sex. Plan B is currently available without a prescription for women 17 and older. The effectiveness of Plan B has been called into question after numerous studies have shown that increased access and use of Plan B hasn’t reduced pregnancy or abortion rates.

In a clinical trial conducted at 40 family planning clinics across the U.S., 1,242 women (aged 18-35) who requested an emergency contraceptive 48-120 hours after intercourse were given ella. After taking ella, 27 women became pregnant. This is a pregnancy rate of 2.2% and the study estimated the pregnancy rate should be 5.5%.

Another clinical trial with women from the U.S., the United Kingdom and Ireland showed that of 844 women taking ella 0 to 120 hours after sex, 1.9% became pregnant compared to an estimated pregnancy rate of 5.6%. Ten percent of the women in this study took ella more than 72 hours after sex and none of them became pregnant.

Prolife groups are also concerned that ella could also be used to abort pregnancies. The FDA admits the data on ella is “too limited to draw any definitive conclusions regarding the effect of (ella) on an established pregnancy and fetal development.” Planned Parenthood frequently distributes both Plan B and RU-486 past the FDA-approved time guidelines, (3,4) and prolife organizations fear that without a required pregnancy test, ella could be prescribed by Planned Parenthood and used beyond the 120 hours post-sex guidelines to abort pregnancies.

(1) FDA's labeling information on ella.  Online at http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022474s000lbl.pdf

(2) Prolife groups who have raised concerns about ella include (but are not limited to): American Association of Pro-Life Obstetricians and Gynecologists, Americans United for Life, Concerned Women for America, Democrats for Life of America, Family Research Council Action, Life Issues Institute, National Right to Life Committee, Students for Life of America, Susan B. Anthony List and 40 Days for Life

(3) Via Planned Parenthood’s web site. Accessed online at 8/16/10 http://www.plannedparenthood.org/health-topics/emergency-contraception-morning-after-pill-4363.htm

(4) Via Planned Parenthood’s web site. Accessed online at 8/16/10 http://www.plannedparenthood.org/health-topics/abortion/abortion-pill-medication-abortion-4354.htm

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