Adverse events reporting is voluntary for pill

Marissa Ogle, M.D, wrote the following about the abortion pill, RU-486 and the adverse events connected to it:

“… There is a voluntary reporting of severe adverse events to the manufacturer. This leaves it up to the provider to decide which events are significant enough to report to the drug company, who in turn determines if it is reportable to the FDA.…

Considering the potential adverse events can be life-threatening or even fatal, the voluntary status of reporting is medically irresponsible. A 2006 analysis of adverse event reports (AER) released by the FDA described 5 deaths, 42 life-threatening hemorrhages, 46 serious or life-threatening infections and 17 undetected ectopic pregnancies… This same group of 607 cases required 513 surgical procedures for follow-up, 235 being emergent in nature with 93% of those performed to control hemorrhage. The AER’s discussed in this study relate to the use of mifepristone in otherwise healthy young women and document a significant risk of severe, life-threatening, or even lethal adverse effects.”

Marissa Ogle, M.D. Still Healing:(2016)  20

Study: MM Gary “Analysis of severe adverse events related to the use of mifepristone as an abortifacient” Annals of Pharmacotherapy 40. 2 (2006): 191 – 97

adverse events happen with this pill

6 week old preborn baby, who could be the victim of an abortion by pill

Read more about the health risks of the abortion pill here

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About Sarah

Sarah Terzo is a freelance writer and journalist who works for Live Action. She is a member of the board of The Pro-life Alliance of Gays and Lesbians and Consistent Life.
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