Analysis of Severe Adverse Events Related to the Use of Mifepristone as an Abortifacient

Margaret M. Gary, MD; Donna J. Harrison, MD

Disclosures

The Annals of Pharmacotherapy. 2006;40(2):191-197. 

In This Article

Abstract and Introduction

Abstract

Background: The systematic analysis of morbidity and mortality for the Food and Drug Administration (FDA)-approved medical abortion regimen using mifepristone is possible using data from the FDA's Adverse Event Reporting System.
Objective: To assess mifepristone's mortality, morbidity, sentinel events, and quality of postmarketing surveillance using mifepristone adverse event reports (AERs).
Methods: Six hundred seven unique mifepristone AERs submitted to the FDA over a 4 year span were coded using the National Cancer Institute's Common Terminology Criteria for Adverse Events. Coding was based only on data in AERs and may underestimate severity and treatment rendered. Two board-certified obstetrician/gynecologists, the authors, made individual evaluations, compared them, and agreed upon final coding.
Results: The most frequent AERs were hemorrhage (n = 237) and infection (66). Hemorrhages included 1 fatal, 42 life threatening, and 168 serious cases; 68 required transfusions. Infections included 7 cases of septic shock (3 fatal, 4 life threatening) and 43 cases requiring parenteral antibiotics. Surgical interventions were required in 513 cases (235 emergent, 278 nonemergent). Emergent cases included 17 ectopic pregnancies (11 ruptured). Second trimester viability was documented in 22 cases (9 lost to follow-up, 13 documented fetal outcome). Of the 13 documented cases, 9 were terminated without comment on fetal morphology, 1 was enrolled in fetal registry, and 3 fetuses were diagnosed with serious malformations, suggesting a malformation rate of 23%.
Conclusions: Hemorrhage and infection are the leading causes of mifepristone-related morbidity and mortality. AERs relied upon by the FDA to monitor mifepristone's postmarketing safety are grossly deficient due to extremely poor quality.

Introduction

Since the Food and Drug Administration (FDA) approved mifepristone in September 2000, safety concerns have mounted; the FDA's July 2005 press release[1] announcing 2 additional deaths underscored these worries. To date, the FDA has not publicly described mifepristone's non-fatal sequelae as discovered through adverse event reports (AERs). This study systematically analyzes mifepristone AERs submitted between September 2000 and September 2004, using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAEv3; Table 1 ).[2] CTCAE coding allows for data analysis by providing uniform numerical grading of event severity across different diagnoses.

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