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Friday, September 3, 2010

FDA Approves a New “Morning After Pill”

Emergency Contraception Part One

woman with pill and glass


It has been estimated that up to half of unintended pregnancies could be prevented by the use of emergency contraception. Starting August 13, 2010, women in the U.S.  have another option for an emergency contraceptive pill (ECP). The FDA has approved a new ECP, with a trade name of “Ella” (also referred to as “EllaOne”). It has received FDA approval for emergency prevention of pregnancy for up to five days after unprotected sex.

Thus, it seems like a good time to revisit our most frequent questions about ECP while giving you an update on the newest option in this blog series.

What have been my choices before?

While a copper IUD can be used as an emergency contraceptive (with the additional benefit of giving long-term birth control), the most commonly used methods have been some type of hormone containing pill. In the 1960′s, very high doses of estrogen were used as an ECP. But there were health risks of this regimen, so the search began for a lower dose product.

In 1972, Dr. Albert Yuzpe and colleagues began studying formulas similar to regular birth control pills. They discovered that using two of the older, high-dose birth control pills, followed by a second dose 12 hours later, could provide emergency contraception. Clinicians, and women, realized that the same dose could be given by using as many as four tablets of lower dose pills (e.g., Nordette or the yellow pills of Triphasil) given 12 hours apart.

This so-called “Yuzpe method” was most effective if started within three days of unprotected sex. Best results occurred if the medication was taken within 12-24 hours. Yet, about 50 percent of women had marked nausea and 20 percent vomited (Ellertson & Webb, 2003). This led to questions about whether the medication had sufficient chance to be absorbed. Some doctors suggested the addition of anti-nausea drugs!

In other countries, another option was being studied. Many large studies, some conducted by WHO, discerned that the unwanted side effects of ECP could be minimized by eliminating the synthetic estrogen found in regular birth control pills and increasing the dose of synthetic progesterone. A common synthetic progesterone (levonorgestrel) used in birth control products could be given in a 0.75 mg dose followed by the same dose within 12 hours. It was equally effective if used within 48-72 hours of the unprotected sex. This was the template for the ECP we now know as “Plan B” or “Next Choice.”

In my next post, I’ll discuss what’s different with the “Ella” ECP and which of the ECPs you can get without a prescription.

Read more from the series:

Ask your questions about ECPs on the Gynecology Community.

Posted by: Jane Harrison-Hohner, RN, RNP at 12:25 pm


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