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August 17, 2010

FDA Approves of New Emergency Contraceptive Pill

The U.S Food and Drug Administration have approved of ella, a new one-dose emergency contraceptive that works longer than the current leading drug on the market.  In June this year, the FDA unanimously voted that the use of ella provided convincing data and sufficient information on its safety.  ella was approved last year in Europe under the name ellaOne and is currently used in 22 countries.

The FDA approved ella as a prescription-only birth control option.  This ruling allows for U.S sales of the drug.  Ella from HRA Pharma is to be marketed as an emergency contraceptive that can be taken within 5 days of unprotected sex or contraceptive failure.  The current emergency contraceptive drug ‘Plan B’ is approved for use up to 3 days after unprotected intercourse.

In a trial between Plan B and ella, women randomly received one of the two pills within three to five days of having unprotected sex.   Women who took ella had a 1.8 percent chance of becoming pregnant.  Women who took plan B had a 2.6 percent chance.

Consequently, Plan B is currently available without a prescription for those 17 and older where as ella will require a doctor’s prescription.  HRA Pharma did not request an over-the-counter position for ella.

There is some concern about women becoming confused by the use of ella. Although ella prevents ovulation for as long as 5 days after sex, some women may believe that once taking ella, it can protect them against pregnancy from any additional acts of unprotected sex for 5 days.  This is not true as sperm from additional sex can outlive the initial sperm past the 5 day window.  In addition, the FDA is concerned about the obesity rates in the US and ella’s effect on overweight and obese women.   Ella seems to be less effective in obese women.

Ella works differently than Plan B.  Though both emergency contraceptives contain hormones that prevent ovulation, ella also contains ulipristal, a non-hormonal drug that blocks the effects of hormones necessary for conception.  Ella belongs to the same class as a drug called mifepristone – a drug that is used as a part of a treatment that induces abortion. This calls for criticism from pro-life groups who believe that ella is closer to an abortion pill than an emergency contraceptive pill.   However, ella is used at lower doses that prevent conception and should not cause abortion.  It is still unknown whether or not ella will affect an existing pregnancy, or if ella might increase the rate of spontaneous miscarriage in the few women who become pregnant despite using ella.

The FDA reviewers reported no life-threatening medical side effects with ella. The most common side effects were mild and included headache, nausea, and abdominal pain.

Birth Control Buzz is a service company that provides birth control prices, types of birth control(prescription required), health administrative services, and birth control statistics predominantly to US patients seeking to purchase pharmaceuticals on-line. For more information, call 1-866-868-8850 or visit http://www.birthcontrolbuzz.com/.

1 Comment »

  1. The 5 day window needs to be taken seriously. My friend Daniella was an early tester, and got pregnant in transition. Ella may be slightly revolutionary in the ortho birth control arena, but awareness and education still rule. Great article.

    Comment by Chantara — August 22, 2010 @ 5:49 pm

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