| Analysis of severe adverse events related to the use of mifepristone as an abortifacient. | |
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MedLine Citation:
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PMID: 16380436 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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Margaret M Gary; Donna J Harrison |
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Publication Detail:
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Type: Journal Article Date: 2005-12-27 |
Journal Detail:
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Title: The Annals of pharmacotherapy Volume: 40 ISSN: 1060-0280 ISO Abbreviation: Ann Pharmacother Publication Date: 2006 Feb |
Date Detail:
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Created Date: 2006-02-07 Completed Date: 2006-03-31 Revised Date: 2006-10-13 |
Medline Journal Info:
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Nlm Unique ID: 9203131 Medline TA: Ann Pharmacother Country: United States |
Other Details:
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Languages: eng Pagination: 191-7 Citation Subset: IM |
Affiliation:
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American Association of Profile Obstetricians and Gynecologists, Eau Claire, MI 49111-0414, USA. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Abortifacient Agents, Steroidal
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administration & dosage,
adverse effects* Abortion, Induced Adolescent Adult Adverse Drug Reaction Reporting Systems* Female Humans Middle Aged Mifepristone / administration & dosage, adverse effects* Severity of Illness Index |
| Chemical | |
Reg. No./Substance:
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0/Abortifacient Agents, Steroidal; 84371-65-3/Mifepristone |
| Comments/Corrections | |
Comment In:
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Ann Pharmacother. 2006 Jun;40(6):1215-6; author reply 1216-7
[PMID:
16735658
]
Ann Pharmacother. 2006 Apr;40(4):785-6; author reply 786 [PMID: 16569806 ] Ann Pharmacother. 2006 Apr;40(4):784; author reply 784-5 [PMID: 16595574 ] |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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