Original research articleSafety of mifepristone abortions in clinical use
Introduction
In September 2000, the U.S. Food and Drug Administration (FDA) approved mifepristone for use in the United States. In approving mifepristone, the FDA considered data from clinical trials showing mifepristone to be safe and effective for early pregnancy termination [1], [2], [3]. Subsequent studies have helped refine regimens used for medication abortion [4], [5], [6], [7], [8], [9], [10], [11], [12].
While extensive data from clinical trials attest to mifepristone's safety and efficacy, less information is available about its safety in routine clinical use. In addition to case series data [13], [14], national information has been provided by Danco Laboratories, the drug's manufacturer in the United States. Among the 80,000 women estimated by the manufacturer to have used the drug in the first year after its approval, 139 were reported to have encountered adverse events and the percentage of complications was estimated to be 0.17% [15]. However, interpretation of the information was limited by the fact that the total number of mifepristone abortions performed is an estimate based on sales data. The number of tablets sold does not translate directly into the number of procedures performed, since clinicians could prescribe either three tablets (600 mg, in the original FDA regimen) or one tablet (200 mg, in an updated regimen) per patient. Danco Laboratories used national surveys, such as one finding that 83% of providers are using 200 mg of mifepristone [16], to formulate its estimate of the total number of procedures performed.
We report data from the experience of the Planned Parenthood Federation of America (PPFA) with mifepristone abortion from 2001 through the first quarter of 2004. These national data provide up-to-date information about the safety of mifepristone abortion in routine clinical use based on 95,163 mifepristone abortions over 3 years. The study was approved by an independent institutional review board (Independent Review Consulting) and given an exempt approval by the Committee on Human Research of the University of California, San Francisco.
Section snippets
Methods
The availability of mifepristone abortion at PPFA affiliates has risen steadily since 2001. At the end of the first quarter of 2004, the PPFA had 202 sites in 39 states offering mifepristone abortion. Prior to February 2002, the PPFA permitted mifepristone termination only up to 49 days from one's last menstrual period (LMP). From that time forward, the method was offered for up to 63 days from the LMP based on an updated protocol. PPFA affiliates administer 200 mg of mifepristone in clinics
Results
A majority of affiliates offer mifepristone abortion up to 63 days from the LMP (81.1%), with some affiliates reporting limits of 49 or 56 days from the LMP (Table 1). Over the study period (2001–2004), 95,163 women obtained mifepristone abortions from PPFA affiliates in the United States.
Of the 95,163 women, 206 women experienced a complication for which hospital treatment was sought (Table 2). Evidence of failed attempted abortion was reported for 3.5 in 1000 mifepristone abortions (95% CI
Discussion
The data reported here provide evidence, based on routine clinical use from 2001 to 2004, supporting mifepristone as a safe and effective method of early pregnancy termination. Abortions counted for this study are from a centralized reporting system that collects affiliates' reports of the number of medication abortions provided each quarter based on billing records and procedure logs. The ability to calculate safety estimates from an actual count of the number of mifepristone abortions
Acknowledgments
This work was funded in part by a grant from the Wallace Alexander Gerbode Foundation.
The authors thank the PPFA for access to these data and the national affiliates for their reporting diligence and cooperation. They are also grateful to Tracy Weitz and an anonymous referee for valuable input.
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