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

Conclusions

The AERs discussed above relate to the use of mifepristone in otherwise healthy young women and document a significant risk of severe, life-threatening, or even lethal adverse events. The most common of these adverse events are hemorrhage, infection, and missed diagnosis of ectopic pregnancies. The most commonly fatal adverse event is sepsis, which may present without fever and progress rapidly to death.

Although neither the manufacturer nor the FDA recognizes a causal link between the use of mifepristone and the adverse events reported, it is undeniable that these women were healthy before the use of mifepristone and became very sick or died shortly after its use. Before any medication is used, a prudent practitioner weighs carefully the risks of the medication with the potential benefits. Medications, such as chemotherapy agents, with life-threatening or potentially lethal adverse effects are acceptable in treating conditions that are themselves debilitating or lethal such as cancer, HIV, sepsis, and others. In these cases, alternative treatments are limited and, without treatment, the disease is rapidly lethal. The use of mifepristone as an abortifacient, however, is radically different. Pregnancy in most instances is a benign, self-limited condition, with duration of approximately 8 months from diagnosis for most women. It generally occurs in otherwise healthy young women. The choice of mifepristone termination over surgical termination is based mainly on patient perceptions of safety, convenience, and privacy, but these perceptions do not accurately reflect the realities of the regimen.

Furthermore, complete, accurate data concerning the public health risk posed by the mifepristone/misoprostol regimen currently in use are not being gathered through the FDA's Adverse Event Reporting System. After reviewing over 600 AERs, we believe that the FDA must promptly conduct a thorough review of this aspect of its postmarketing surveillance system to determine whether the failures described above are peculiar to mifepristone reports or are systemic to all drug reports.


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