U.S. health regulatory staff said in documents released on Tuesday that a new, longer-lasting “morning-after” pill to prevent unwanted pregnancy appears to work with no unexpected side effects.
The FDA said in its documents that 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.
The FDA’s panel of outside experts will decide whether to recommend the agency to approve the drug for the U.S. market. Watson Pharmaceuticals would sell the drug in the U.S. if approved.
The HRA Pharma drug has re-ignited debate over “morning-after” pills in the U.S., where reproductive issues are a constant political issue.
Women’s health advocates have welcomed the potential for another emergency contraceptive option, but some critics are concerned the drug is more akin to the abortion pill, known as RU-486 or mifepristone.
HRA Pharma said its drug works by preventing ovulation of a woman’s egg.
FDA staff scientists said in their review that the company’s studies showed no unexpected side effects in women, although reports of nausea, headache and abdominal pain were common. They added that it was not clear what effect the drug had, if any, when a woman still became pregnant despite taking it.
“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.
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