RU-486 was approved under a special "restricted distribution" process reserved only for
drugs that treat "severe or life-threatening illnesses."
The clinical trials to test the safety and efficacy of RU-486 violated FDA's standards and
under-reported the severity of the complications.
Even these biased trials in the U.S. resulted in 99 percent of the test subjects suffering
Nearly all the safety precautions the FDA knew were necessary to protect women from being
injured or killed by RU-486--and are required in other countries--were dropped under political
The FDA ordered a second drug, misoprostol, be used with RU-486--but the owner of
misoprostol warned doctors it should not be used for abortion.
Abortionists are not following even the weak restrictions set by the FDA.
Complications reported to the FDA since it approved RU-486 include two fatalities and 20
near-fatal complications, including a heart attack, two cases of systemic bacterial infection in
15 year olds, and several hospitalizations for hemorrhaging.
Concerned Women for America's project to revoke the FDA approval of RU-486. Call for a free copy of Family Voice magazine.