5 RU-486

A new report from the U.S. Food and Drug Administration reveals a listing of “adverse events” regarding use of mifepristone (RU-486). According to the data, 14 women have died using the abortion drug and 2,207 American women have sustained injuries. Approx 1.5 million women have taken the drug so far.

The following information is from United States post-marketing reports (i.e., not from a clinical trial)
received by FDA of adverse events that occurred among patients who had taken mifepristone for medical
termination of pregnancy.  Because FDA has eliminated duplicate reports, and in some cases, reclassified
the adverse event terms for individual cases after reviewing the narrative details, the numbers provided
here may differ from the numbers of the reports that may be obtained through Freedom of Information
Act requests.  These events cannot with certainty be causally attributed to mifepristone because of
information gaps about patient health status, clinical management of the patient, concurrent drug use and
other possible medical or surgical treatments.  The estimated number of women who have used
mifepristone in the US through the end of April 2011 is approximately 1.52 million women.

The following information is from United States post-marketing reports (i.e., not from a clinical trial) received by FDA of adverse events that occurred among patients who had taken mifepristone for medical termination of pregnancy.  Because FDA has eliminated duplicate reports, and in some cases, reclassified the adverse event terms for individual cases after reviewing the narrative details, the numbers provided here may differ from the numbers of the reports that may be obtained through Freedom of Information Act requests.

These events cannot with certainty be causally attributed to mifepristone because of information gaps about patient health status, clinical management of the patient, concurrent drug use and other possible medical or surgical treatments.  The estimated number of women who have used mifepristone in the US through the end of April 2011 is approximately 1.52 million women.

Of those who experienced problems following use of the drug:

  • 612 required hospitalization
  • 339 required a transfusion from blood loss
  • 256 experienced infections
  • 48 experienced severe infections.

More details here.

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