RU486: FDA's monitoring of postmarketing safety grossly deficient to extremely poor quality Print E-mail

  Online publication December 27 2005;

February 2006 Vol. 40, No. 2, pp. 191-197

RESEARCH REPORTS: WOMEN'S HEALTH

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

Margaret M Gary, MD Obstetrician/Gynecologist, Virginia Beach, VA
Donna J Harrison, MD Chairperson, Subcommittee on Mifeprex, American Association of Prolife Obstetricians and Gynecologists, Eau Claire, MI

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.

Key Words: adverse event reporting system (AERS), medical abortion, Mifeprex, mifepristone, mifepristone adverse events, mifepristone-induced septic shock (MISS), RU486

Reprints: Dr. Harrison, American Association of Prolife Obstetricians and Gynecologists, PO Box 414, Eau Claire, MI 49111-0414,