New Morning After Pill

FDA panel says new morning-after pill is safe, effective.
ABC World News (6/17, story 7, 0:25, Sawyer) reported, "A new type of morning-after pill is a big step closer to going on sale in the US. Today, an FDA advisory panel voted unanimously that the pill called ellaOne [ulipristal acetate] is safe and effective."
The CBS Evening News (6/17, story 8, 0:25, Couric) reported, "Studies show it can prevent pregnancy up to five days after intercourse. That's two days more than the over-the-counter Plan-B [levonorgestrel] pill."
NBC Nightly News (6/17, story 5, 1:35, Holt) chief medical editor Nancy Snyderman, MD, explained that the new pill "is a close chemical cousin to the morning-after pill RU-486 [mifepristone]."
The New York Times (6/18, A14, Harris) reports, "Ella blocks the effects of progesterone, a female hormone that spurs ovulation," but "some mystery remains over exactly how it works. That mystery spurred a fierce debate outside the committee over whether it should be considered an abortion drug." The dispute focuses on "whether the drug works by delaying ovulation (as the pill's manufacturer claims) or by preventing a fertilized egg from implanting itself in the uterus (as anti-abortion advocates say)."
"The positive recommendation moves the pill, which is already approved in Europe, one step closer to the US market," the AP (6/18, Perrone) reports. In studies conducted "by the drug's manufacturer, HRA Pharma...ellaOne prevented pregnancies longer and more consistently than Plan B." In a head-to-head comparison of the two drugs in nearly 1,700 women, researchers found that women "who took ellaOne had a 1.8 percent chance of becoming pregnant, while women who took Plan B had a 2.6 percent chance."
WebMD (6/17, DeNoon) pointed out that the drug, if approved, would be known in the US as Ella, even though it is sold in Europe under the name EllaOne. WebMD also noted that "one possibly serious drawback to Ella is that it may be less effective in obese women." However, "in a 6-5 vote, the panel said no specific labeling should be required to address this issue."
MedPage Today (6/17, Walker) reported that side effects reported in trials "were headache, nausea, dysmenorrhea, abdominal pain, fatigue, and dizziness, which were reported by at least 5% of all women in the studies. The safety profile is similar to that of levonorgestrel."