Objectives: Extensive data from clinical trials document mifepristone's safety and efficacy for induced abortion, but less information is available about its safety in routine clinical use.
Methods: Data on mifepristone abortion use from the Planned Parenthood Federation of America, the largest provider of mifepristone abortion in the United States, from 2001 through the first quarter of 2004 were collected using a centralized reporting system. Over the study period, 95,163 mifepristone abortions were provided. Reportable events are complications requiring inpatient or outpatient hospital treatment.
Results: Overall, 2.2 per 1000 women (95% CI 1.9-2.5) experienced a complication, most commonly, heavy bleeding. Mifepristone abortion mortality is estimated to be 1.1 per 100,000 based on one death (95% CI 0.3-5.9).
Conclusions: The safety of mifepristone is high; few serious medical complications occur in routine clinical use.