Aligning mifepristone regulation with evidence: driving policy change using 15 years of excellent safety data

Abstract

Mifepristone was approved for use in the United States 15 years ago this month. The importance of this medication is undeniable, as currently about one-third of abortions in the US are medical abortions using evidence-based mifepristone and misoprostol regimens (using 200 mg mifepristone and 800 mcg misoprostol, up to 63 days of gestation). Years of experience and research with the many hundreds of thousands of women who have used mifepristone for medical abortion demonstrates that this method is exceptionally safe. Rates of hospital admission, bleeding requiring transfusion and serious infection are lower than 0.5% across large studies that, in total, include over 430,000 women. Reported rates of ongoing pregnancy range from 0.13% to 1.1%. Undiagnosed ectopic pregnancies, as well as deaths attributable to medical abortion are exceedingly rare. In addition to the well-established body of research supporting the safety of current evidence-based regimens, there is a strong and growing literature demonstrating the low risk of expanded protocols including use of mifepristone up to at least 70 days of gestation, home use of the medications, and alternative follow-up methods including semi-quantitative pregnancy tests. The current FDA-approved label for mifepristone does not yet reflect the widely used best-practice protocols that have been adopted both in the US and abroad; but scientific literature provides substantial reassurance that aligning the mifepristone label with the evidence would continue to maintain the safety and efficacy of this method while greatly improving access for women.

Comment: This is another paper arguing the safety of a mifepristone/misoprostol combination for medical abortion up to 10 weeks amenorrhea. The literature supports the fact that women can use the medical regimen, instead of going for surgical abortion, at least up to 70 days of gestation. (HMV)