Ella the Week After Pill an Emergency Contraceptive Made by Watson Pharmaceuticals Is Approved

(WSJ) The Food and Drug Administration approved ella, a new drug that is supposed to block pregnancy up to five days after sex, two days longer than the currently available emergency contraceptive Plan B.

The new medication, a tablet to be available by prescription, will be sold in the U.S. by Watson Pharmaceuticals Inc., starting in the fourth quarter of this year. A Watson spokesman declined to comment on pricing or marketing plans. quarter.

The drug was developed by HRA Pharma, a closely held company in Paris, which started selling it in Europe last year under the name ellaOne.

The FDA’s review of the product reignited a long-running debate over the effects of such emergency contraceptives. Some antiabortion groups argue products such as ella can act to end pregnancies, rather than simply prevent them.

“The bottom-line concern is that it’s a drug that causes an abortion,” said Jeanne Monahan, director of the Family Research Council’s Center for Human Dignity.

The FDA-approved labeling for ella, generically known as ulipristal, says the drug is an emergency contraceptive to be used for prevention of pregnancy. The label says ulipristal likely works by inhibiting or delaying ovulation, but its efficacy also may be partly due to an effect of altering the lining of the uterus in a way that affects implantation. The ella label also says that women who are pregnant shouldn’t take it.

“It’s used to prevent ovulation,” the Watson spokesman said. “It’s not an abortion drug.” An HRA spokeswoman said she wasn’t authorized to comment.

Plan B, which is supposed to be taken up to three days after intercourse, sparked years of controversy while the FDA mulled whether to allow its sale without a prescription. Currently, it can be sold over-the-counter to those 17 and older, while younger teens require a prescription. Plan B is marketed by Teva Pharmaceutical Industries Ltd., while Watson sells a generic version under the name Next Choice.

Side effects of ella can include headache and nausea, according to the label. The drug was approved based primarily on two studies. In one, involving 1,242 women, the pregnancy rate was 2.2 per 100 women when the drug was taken between 48 and 120 hours after sex. That was less than half the expected rate of 5.5 if they hadn’t taken the drug. In the other study, involving 844 women, the rate was 1.9, compared to an expected 5.6, when ella was taken within 72 hours after intercourse.