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Chairperson, Obstetrician/Gynecologist, Virginia Beach, Virginia
Subcommittee on Mifeprex, American Association of Prolife Obstetricians and Gynecologists, PO Box 414, Eau Claire, Michigan 49111-0414. djharrison{at}juno.com
Published Online, March 7, 2006. www.theannals.com, DOI 10.1345/aph.1G481b
Although mifepristone's manufacturer denies a causal link between the drug and the deaths and other adverse events reported in our article, the Food and Drug Administration recently released a Guidance Document on Adverse Event Reports that provides additional credence to the theory that mifepristone played a causal role in the adverse events reported. The document states that "Typical reasons to suspect causality for an event include (1) timing of onset or termination with respect to drug use, (2) plausibility in light of a drug's known pharmacology, (3) occurrence at a frequency above that expected in the treated population, and (4) occurrence of an event typical of drug-induced adverse reactions."2 In the case of mifepristone, the first 3 criteria were clearly met in the deaths as well as in the severe and life-threatening adverse events reported in our article.
Svedas et al. mention one especially interesting point that we did not develop in our article—the etiology of the profuse hemorrhages seen with mifepristone abortions. Hemorrhagic sequelae were also reported by investigators using data from one of the sites of the US clinical trial of mifepristone.3 They reported increased quantity and duration of bleeding in mifepristone abortions compared with a nonconcurrent control group of surgical abortions. Another investigator reported profuse bleeding as a frequent complication of mifepristone abortions.4 Further investigation into the pathologic and histologic basis for the hemorrhagic sequelae of mifepristone abortions is certainly warranted.
Svedas et al. also mentioned the dearth of studies investigating long-term consequences from mifepristone abortions. Considering an article linking abortion to increases in subsequent mental health disorders,5 it may be prudent to specifically examine the long-term psychological effects of mifepristone abortions.
The dearth of rigorous scientific scrutiny of adverse events associated with mifepristone abortion is not limited to long-term complications. Concerns about underreporting of abortion-related morbidity and mortality have been published.6,7 The lack of adequate real-world data on the morbidity and mortality attributable to abortions impedes an accurate scientific assessment of the risks and benefits associated with these procedures.
Footnotes
Drs. Gary and Harrison are members of the Subcommittee on Mifeprex of the American Association of Prolife Obstetricians and Gynecologists (AAPLOG), the largest interest group of the American College of Obstetricians and Gynecologists. AAPLOG has filed a Citizen Petition with the Food and Drug Administration requesting withdrawal of approval for mifepristone based on safety considerations.
References
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