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

Methods

The FDA released 637 mifepristone AERs documenting 607 unique events pursuant to a Freedom of Information Act request. All identifiers for patient, practitioner, or facility were removed from the AERs. Mifepristone's distributor submitted 592 of the 637 AERs; the rest were filed from various sources including foreign health authorities, Pharmacia, and others.

The vast majority of mifepristone AERs submitted to the FDA by the drug sponsor lacked critical information needed for complete case assessment.[3,4,5,6,7,8,9,10] Analysis and coding were based only on the contents of the AER. Even if the facts presented in the AER strongly suggested a standard course of treatment (eg, transfusion), that treatment was deemed not to have taken place unless there was explicit documentation. Consequently, poor AER documentation almost certainly resulted in the underestimation of the severity of some adverse events.

An absolute rate of mifepristone abortion complications in the US cannot be determined from the FDA's AERs because these voluntary and sporadically submitted reports provide neither an accurate numerator (number of adverse US events) nor an accurate denominator (number of US mifepristone abortions). However, the data allow some estimation of the types, severity, and percent frequency of reported events. Sentinel events requiring further investigation were also recognizable.

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