Need to know about ella®?




What is ella?
Is ella Effective?
How is ella Administered?
Should I take ella?
Can ella really cause an abortion?
Does ella have side effects and risks?
What is unknown about ella?



What is ella?
ella is a form of emergency contraception. This means it is a type of birth control used after unprotected intercourse or suspected contraceptive failure (e.g. a broken condom) to prevent pregnancy.

It cannot be purchased over-the-counter and is only available by prescription in the United States.

ella is not intended for routine use as a contraceptive.[1] It is only to be used for a single episode of unprotected intercourse.[2]


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Is ella Effective?
If ella is taken as directed, it will reduce the chance of pregnancy, but it is not effective in every case.

In the two studies mentioned in the package insert, ella reduced the number of expected pregnancies from about 5.5% to an observed number of about 2%.[3] It is important to realize that this number is an estimate based on the number of pregnancies per 100 women at risk for pregnancy as calculated based upon the timing of intercourse with regard to each woman’s menstrual cycle.[4]

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How is ella Administered?
ella is taken orally as one tablet as soon as possible within 120 hours (5 days) after unprotected intercourse or a known or suspected contraceptive failure.[5] The ella tablet is a white to off-white, round, curved tablet containing 30 mg of ulipristal acetate and is marked “ella” on both sides.[6]

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Should I take ella?
Many times women panic after having unprotected sex and rush to take emergency contraception, such as ella. However, you can only become pregnant on certain days of the month — around the time that you ovulate. Taking ella during a time when you cannot become pregnant needlessly exposes you to a new drug that has not been fully tested (see “What is unknown about ella” below). It is possible that you are already pregnant from an earlier episode of sex.

ella should not be used if you are or may be pregnant, if you are breast-feeding, for regular contraceptive use, or more than once during one menstrual cycle.[7] According to the manufacturers, pregnancy should be excluded before prescribing ella.[8] If pregnancy cannot be excluded on the basis of history and/or physical examination, pregnancy testing should be performed.[9] To find out if you are pregnant, contact us, and we’ll connect you with a caring, qualified pregnancy center near you.

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Can ella really cause an abortion?
ella may act to reduce a woman’s chances of becoming pregnant by preventing or postponing ovulation. It may also change the lining of the uterus so that the embryo cannot implant in the uterus.[10]

The manufacturers of ella claim that the drug will not cause an abortion when it is taken correctly. This is based upon the assumption that life begins when the fertilized egg implants into the uterine wall. However, the scientific reality is that life begins at conception when the egg is fertilized. When the sperm penetrates the egg (fertilization), the sex, hair, eye color, height, etc. have all been determined and a new life has begun.

It is important to know that ella is a chemical cousin to the abortion pill Mifeprex, which is also called RU-486. ella and Mifeprex both work by blocking progesterone, which is a hormone needed for the establishment and maintenance of a pregnancy. When progesterone is blocked, the embryo is prevented from attaching to the uterus. If the embryo is already attached to the uterus, then the connection to the womb is dissolved and the embryo detaches and dies. This is clearly an abortion. Only limited studies were done with women who were early in pregnancy.

However, based upon how this drug worked in animals that were tested, it is reasonable to expect that ella would also have an abortive effect on early pregnancies in humans.

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Does ella have side effects and risks?
The most common adverse reactions of ella include headache, nausea, stomach (abdominal) pain, menstrual cramps, fatigue, and dizziness.[11] Women who experience abdominal pain three to five weeks after using ella should be evaluated right away for an ectopic pregnancy by a physician.[12] An ectopic pregnancy can be life-threatening.

After a woman takes ella, her period may occur earlier or later than expected by a few days.[13]


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What is unknown about ella?
Much is unknown about the drug, including the following:

  • its effects on women under 18 years of age [14]
  • its effects on women over age 35 [15]
  • its effects on women taking other forms of hormonal contraception [16]
  • its effects on pregnant women [17]
  • its effects on women who are breast-feeding [18]
  • its effects after repeated use within the same menstrual cycle [19]
  • its effects on women who have not started their period [20]

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Remember, your body and health are important, so take time to make the best decision. Please contact us to get more information.


Resources:
1. ella package insert. “Indications and Uses.” Package insert available at: http://pi.watson.com/data_stream.asp?product_group=1699&p=pi&language=E (Accessed December 20, 2010)
2. ella package insert. “How effective is ella?” Package insert available at: http://pi.watson.com/data_stream.asp?product_group=1699&p=pi&language=E (Accessed December 20, 2010)
3. ella package insert. “Clinical Studies.” Package insert available at: http://pi.watson.com/data_stream.asp?product_group=1699&p=pi&language=E (Accessed December 22, 2010)
4. ella package insert. “Clinical Studies.” Package insert available at: http://pi.watson.com/data_stream.asp?product_group=1699&p=pi&language=E (Accessed December 22, 2010)
5. ella package insert. “Dosage and Administration.” Package insert available at http://pi.watson.com/data_stream.asp?product_group=1699&p=pi&language=E (Accessed December 20, 2010)
6. ella package insert. “Dosage Forms and Strengths.” Package insert available at: http://pi.watson.com/data_stream.asp?product_group=1699&p=pi&language=E (Accessed December 30, 2010)
7. ella package insert. “Patient Counseling Information.” Package insert available at http://pi.watson.com/data_stream.asp?product_group=1699&p=pi&language=E (Accessed December 20, 2010)
8. ella package insert. “Warnings and Precautions.” Package insert available at http://pi.watson.com/data_stream.asp?product_group=1699&p=pi&language=E (Accessed December 20, 2010)
9. ella package insert. “Existing Pregnancy.” Package insert available at http://pi.watson.com/data_stream.asp?product_group=1699&p=pi&language=E (Accessed December 20, 2010)
10. ella package insert.” Mechanism of Action.” Package insert available at http://pi.watson.com/data_stream.asp?product_group=1699&p=pi&language=E (Accessed December 20, 2010)
11. ella package insert. “Adverse Reactions.” Package insert available at http://pi.watson.com/data_stream.asp?product_group=1699&p=pi&language=E (Accessed December 20, 2010)
12. ella package insert. “Patient Counseling Information.” Package insert available at: http://pi.watson.com/data_stream.asp?product_group=1699&p=pi&language=E (Accessed December 30, 2010)
13. ella package insert. “Effect on Menstrual Cycle.” Package insert available at http://pi.watson.com/data_stream.asp?product_group=1699&p=pi&language=E (Accessed December 20, 2010)
14. ella package insert. “Pediatric Use.” Package insert available at http://pi.watson.com/data_stream.asp?product_group=1699&p=pi&language=E (Accessed December 20, 2010)
15. ella package insert. “Clinical Studies.” Package insert available at: http://pi.watson.com/data_stream.asp?product_group=1699&p=pi&language=E (Accessed December 30, 2010)
16. ella package insert. “Patient Counseling Information.” Package insert available at http://pi.watson.com/data_stream.asp?product_group=1699&p=pi&language=E (Accessed December 30, 2010)
17. ella package insert. “Pregnancy.” Package insert available at http://pi.watson.com/data_stream.asp?product_group=1699&p=pi&language=E (Accessed December 20, 2010)
18. ella package insert. “Nursing Mothers.” Package insert available at http://pi.watson.com/data_stream.asp?product_group=1699&p=pi&language=E (Accessed December 30, 2010)
19. ella package insert. “Repeated Use.” Package insert available at http://pi.watson.com/data_stream.asp?product_group=1699&p=pi&language=E (Accessed December 20, 2010)
20. ella package insert. “Pediatric Use.” Package insert available at http://pi.watson.com/data_stream.asp?product_group=1699&p=pi&language=E (Accessed December 30, 2010)

Source: http://www.optionline.org/morningafterpill#ella

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