Ella Wins FDA Approval

Much controversy has swirled around the birth control pill ella™ (ulipristal acetate) which prevents pregnancy when taken orally within five days after a contraceptive failure or unprotected intercourse.

The Food and Drug Administration approved the drug yesterday as a prescription-only, emergency contraceptive. The ruling clears the way for U.S. sales of the drug, which is already approved in Europe.  Since May 2009, the prescription product has been available in Europe under the brand name ellaOne.

Upon approval of the drug, the FDA said, "ella™ is a progesterone agonist/antagonist whose likely main effect is to inhibit or delay ovulation."  The timid language used to describe the objective of the drug, phrasing such as "whose likely main effect", enhance the mystery of how ella™ works and fuels the debate between advocates and opposers of the drug. 

It blocks the effects of progesterone, a female hormone that spurs ovulation and is a chemical relative to RU-486, the abortion pill.  There is some evidence that ella makes the womb less hospitable to a fertilized egg by reducing the lining of the uterus.

Scientists on the advisory committee considered whether the pill works by preventing ovulation or preventing implantation of a fertilized egg as immaterial when deciding the safety and effectiveness of the pill. 

The distinction is crucial in the minds of those who do not support abortion, as they consider preventing implantation of a fertilized egg equal to abortion.

The FDA reports the safety and efficacy of ella™ were demonstrated in two Phase III clinical trials. One study was a prospective, multi-center, open-label, single-arm trial conducted in the United States; the other was a randomized, multi-center, single-blind comparator-controlled trial conducted in the United States, United Kingdom and Ireland. 

Plan B, also known as 'the-morning-after" pill, which was approved in 2009 by the FDA to women aged 17 and older without a prescription. Plan B  is comprised of a synthetic hormone that has been used in birth control pills for more than 35 years. The levels of progestin in Plan B are higher than those in birth control pills.

WebMD states, "Plan B does not stop development of a fetus once the fertilized egg implants in your uterus.  It will not work if you are already pregnant when you take it.   It does not cause a miscarriage or abortion."

In a head-to-head trial between the two drugs, women who took ella™ had a 1.8 percent chance of becoming pregnant, while women who took Plan B had a 2.6 percent chance. Experts tracked nearly 1,700 women who randomly received one of the two pills within three to five days of having unprotected sex.

Women who have unprotected intercourse have about 1 chance in 20 of becoming pregnant. Those who take Plan B within three days cut that risk to about 1 in 40, while those who take ella™ would cut that risk to about 1 in 50, regulators say. Studies show that ella™ is less effective in obese women.

“Emergency contraception has no effect on pregnancy rates or abortion rates,” said Dr. James Trussell, director of the Office of Population Research at Princeton, who has consulted without charge for ella’s maker. “Women just don’t use them enough to make an impact.”

FDA approval was based on the theory that ella™ is to be used only for contraceptive failure or unprotected intercourse. It is not intended for routine use as a contraceptive.

Ella™ package warnings and precautions:

    *ella is not indicated for termination of an existing pregnancy. Exclude pregnancy before administering.
    *Ectopic pregnancy: Women who become pregnant or complain of lower abdominal pain after taking ella     should be evaluated for ectopic pregnancy.
    *Effect on menstrual cycle: ella may alter the next expected menses. If menses is delayed beyond 1 week,     pregnancy should be ruled out.
    *ella does not protect against HIV infection (AIDS) or other sexually transmitted infections (STIs).

Ella™ package side effects:
    *headache
    *abdominal pain
    *nausea
    *dysmenorrhea
    *fatigue
    *dizziness

Another long-simmering controversy that may re-ignite with the approval of ella™ is whether pharmacists and doctors can refuse to prescribe or fill prescriptions for birth control measures they find personally objectionable.

Laura Lamp King