A new study published in The New England Journal of Medicine has revealed that ulipristal acetate, the active ingredient in the emergency contraceptive ella, can effectively induce abortions up to nine weeks of pregnancy when combined with misoprostol.
Study Findings and Methodology
The research, conducted by Gynuity Health Projects and the National Autonomous University of Mexico, involved 133 pregnant women from Mexico City. Each participant received a 60-milligram dose of ulipristal acetate followed by misoprostol. The combination achieved a remarkable 97% success rate in completing abortions, matching the effectiveness of the FDA-approved mifepristone-misoprostol regimen.
Beverly Winikoff, President of Gynuity Health Projects and lead researcher, noted, "This is the first study that shows the possibility of using [ulipristal acetate] for abortion." She highlighted the drug's structural similarity to mifepristone, which is currently approved for abortions up to 10 weeks of pregnancy.
Clinical Implications and Controversy
The study's findings have sparked significant debate about the true mechanism of action for emergency contraceptives containing ulipristal acetate. The tested dosage was double the amount currently recommended for emergency contraception, raising questions about potential effects at lower doses.
Aaron Kheriaty, a fellow at the Ethics and Public Policy Center, explained that ulipristal acetate "makes the environment in the womb inhospitable to continue life." He argues that the drug's mechanism remains consistent whether taken shortly after intercourse or weeks later.
Marketing Claims vs. Scientific Evidence
Current marketing for ella and ellaOne maintains these products are non-abortive and only prevent pregnancy. HRA Pharma America, a Perrigo Company subsidiary, states on ellarx.com that ella "won't end an existing pregnancy" and works solely by "delaying or preventing ovulation."
In response to the study, Perrigo issued a statement defending their position, emphasizing that the research used higher doses than their product contains. However, Dr. Winikoff countered, stating, "The study we published could make it possible for people to use [ulipristal acetate] for abortions."
Regulatory and Ethical Considerations
The findings raise important questions about FDA oversight and product labeling. Kheriaty suggests the results "place the medication in the same category as other drugs used for chemical abortions" and calls for FDA investigation into current marketing practices.
The study's implications extend beyond clinical practice into ethical and regulatory territories, potentially affecting how emergency contraceptives are classified, regulated, and marketed in the future.
