New “morning-after” pill safe, effective: FDA staff

A new, longer-lasting “morning-after” pill to prevent unwanted pregnancy appears to work with no unexpected side effects, U.S. health regulatory staff said in documents released on Tuesday.

Data shows the one-pill treatment, called “ella” and made by French drugmaker HRA Pharma, is effective when taken as many as five days after unprotected sex, Food and Drug Administration staff reviewers said in documents released ahead of a public meeting on the drug scheduled for Thursday.

At the meeting, FDA’s panel of outside experts will decide whether to recommend the agency approve the drug for the U.S. market. If approved, Watson Pharmaceutical would sell the drug in the United States.

The HRA Pharma drug, already approved for use in Europe under the name ellaOne, has re-ignited debate over “morning-after” pills in the United States, where reproductive issues are a constant political issue.

Women’s health advocates have welcomed the potential for another emergency contraceptive option, but some critics contend the drug is more akin to the abortion pill, sold by Danco Laboratories as Mifeprex and also known as RU-486 or mifepristone.

HRA Pharma has said its drug, whose scientific name is ulipristal, works by preventing ovulation of a woman’s egg.

In their review, FDA staff scientists said the company’s studies showed no unexpected side effects in women, although reports of nausea, headache and abdominal pain were common. It was not clear what effect the drug had, if any, when a woman still became pregnant despite taking it, they added.

“Data on pregnancy outcomes after EC (emergency contraceptive) failure with ulipristal were too limited to draw any definitive conclusions regarding the effect of ulipristal on an established pregnancy or fetal development,” they wrote.


Provided by ArmMed Media