WASHINGTON, Nov. 16 /PRNewswire/ -- Yesterday the Food and Drug Administration (FDA) announced revised labeling for the drug Mifeprex, most commonly known as RU-486, which was approved in 2000 under the Clinton administration.
The FDA and Danco Laboratories, the drug’s manufacturer, have received reports of serious bacterial infection, sepsis, bleeding, ectopic pregnancies that have ruptured, and death. RU-486 is an abortifacient requiring three doctor visits and two drugs, which kill and expel the unborn child up to 49 days after conception.
“The FDA must place women’s health first. For the last four years, American women have been denied the truth about this drug: that it could seriously harm and even kill them. Instead, their lives were placed in jeopardy, because the approval process for RU-486 was short-circuited due to political motivations,” says Dr. Pia de Solenni, Director of Life and Women’s Issues with Family Research Council.
Even though pregnancy is not a disease, under the Clinton Administration RU-486 was put on an accelerated approval process intended for experimental drugs in the treatment of life-threatening illnesses. RU-486 was known to have serious side effects such as hemorrhaging and uterine rupture. Both were known at the time the drug was approved.
“This is the result of the Clinton legacy,” says de Solenni, “women are dying from a drug that has evaded rigorous testing.”
FRC does not condone the approval or use of RU-486. “The protection of innocent human life as well as the safety and health of American women must be first and foremost in the FDA’s approval process,” continues de Solenni.
Family Research Council
CONTACT: Amber Hildebrand of the Family Research Council,+1-202-393-2100, or adh@frc.org
Web site: http://www.frc.org/