RU-486 Update: Hardly safe, effective

On August 20, 2002, a coalition of prolife groups filed a petition for the U.S. Food and Drug Administration to revoke its approval of the dangerous abortion drug regimen, most commonly known as RU-486. Concerned Women for America, the Christian Medical Association and the American Association of Pro Life Obstetricians and Gynecologists worked together to produce a 92 page document that outlines the FDA’s gross violations of its own policies during their “fast track” approval of the abortion drug on September 28, 2000, during the Clinton presidency. The groups, in their Citizen Petition, called the FDA’s approval of the RU-486, “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with the law.”

The petition was the result of an extensive 22-month investigation, which included the examination of more than 8,000 documents released by the FDA. The petition rightfully accuses the FDA of endangering the health of women by violating federal law and their own standards for approval of New Drug Applications. Some of the FDA’s violations include “the approval of Mifeprex (RU-486) without the submission of data from adequate and well-controlled clinical studies, the inappropriate use of an approval route, Subpart H, and the unprecedented endorsement by the FDA of an off-label use of misoprostol (designed to treat ulcers), the second drug in the Mifeprex Regimen.”

A chemical abortion involves two drugs, Mifeprex (RU-486) and misoprostol (also known as Cytotec). Mifeprex kills the unborn child while in the womb by blocking a hormone that is needed to continue the pregnancy. Cytotec, which is taken two days after Mifeprex, causes uterine contractions which are designed to expel the child. When taken together these drugs cause an abortion in 92 percent of women who are seven weeks pregnant or less.

During its clinical trials the Mifeprex regimen was never proved to be “safe and effective,” a standard that is required by law. The U.S. trials were controlled by the Population Council, the pro-abortion outfit that has the rights to Mifeprex. The petition shows that these trials did not use a full set of design features including randomization, blinding, and a control group to make sure that the results weren’t biased. Even though these trials were run in an unscientific fashion by the organization that desperately wanted the FDA’s approval, they still showed how dangerous this drug regimen can be. Women who took the drugs had numerous complications including abdominal pain, nausea, uterine hemorrhage, excessive bleeding, and viral infections. Death is also a side effect of taking these drugs.

A Canadian woman died on September 1, 2001, from septic shock due to a bacterial infection after taking the drugs. In April of 2002, Danco Laboratories, the maker of the abortion pill, sent a letter to doctors who supplied the drug, informing them that six women developed serious illnesses and two died after taking the dangerous drug cocktail. Three of the women suffered bleeding caused by the rupture of undiagnosed ectopic (tubal) pregnancies and one of these women died. Two women developed serious bacterial infections after taking the drugs and one of the infections was fatal. In another case, a 21 year-old woman had a non-fatal heart attack three days after taking the controversial drugs.

The approval of the abortion drug is a prime example of how pro-abortion organizations set aside concerns for women and their health and safety. Providing as many abortions in a variety of different ways is their main goal.

Right to Life of Michigan will continue to help women and families by offering life-affirming options during unplanned pregnancies.

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