Summary
Regarding the editorial "Holding FDA Hostage," Sen. Jim DeMint from South Carolina is making a principled stand for women's health by holding Dr. von Eschenbach accountable for the FDA's inadequate scrutiny of the abortion pill, mifepristone or RU-486 (Sept. 24). A review of mifepristone adverse events in the Annals of Pharmacotherapy in February 2006 concluded, "Mifepristone presents a significant risk of severe, life-threatening, or even lethal events." The FDA is aware of mifepristone use associated with 12 women's deaths and 116 bleeding episodes serious enough to require blood transfusions.
The FDA has failed to require the drug sponsor, Danco Laboratories, to collect the data in the Phase IV "prescriber monitoring study," to which Danco agreed when the drug was approved. It is reasonable to hold acting Commissioner Andrew von Eschenbach accountable 1) for this failure and 2) for the inadequacies of the Adverse Events Reporting System. It is fair to insist that the FDA protect the American public and get the needed answers about the serious women's health issues surrounding elective abortions with the drug, mifepristone.See the full content of this document
Extract
Fda Fumbles On Abortion Pill
As a citizen, as a hus...
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