FDA Will Review New Morning-After Pill

This week, the U.S. Food and Drug Administration (FDA) will review a new emergency contraception (morning after) pill that is effective up to five days after unprotected sex- two days longer than levonorgestrel (Plan B). The new morning after pill, ulipristal acetate (brand name ellaOne) is as effective taken five days after sex as taken two days after sex. In contrast, Plan B, the current brand name for emergency contraception in the United States, can be taken up to three days after unprotected sex but becomes less effective the longer after sex one takes it.  The increased effectiveness of ellaOne was shown in a study that involved 1,700 women who took a morning-after pill within three days of having unprotected sex. Half were given Plan B and half were given ellaOne. Twenty-two women who took Plan B became pregnant, as opposed to only fifteen women who became pregnant after taking ellaOne.

It is not yet known if ellaOne increases the likelihood of future health problems. It is possible [PDF] that it increases the risk of future ectopic pregnancy, elevated blood pressure, and liver disease. For this reason, if approved by the FDA, ellaOne would only be available by prescription until more safety data is available on the drug.  Plan B and its generic equivalent are currently available over-the-counter for women seventeen and older. Women under the age of seventeen are still not able to purchase emergency contraception without a prescription.

The European Medicines Agency’s Committee for Medicinal Products for Human Use found ellaOne to be effective and its common side effects (stomach pain and menstrual disorder) to not be abnormally severe (PDF). The Committee declared that the “benefits are greater than its risks” of taking ellaOne and approved it for sale. EllaOne is already sold in twenty-one European countries.


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