Counteroffensive on RU-486

Critics allege safety concerns overlooked in FDA approval process
Mark Louviere, a physician in Waterloo, Iowa, is not likely to forget the events of November 29, 1994. He was on call when the emergency room staff of Allen Memorial Hospital paged him. When Louviere arrived at the ER, he immediately examined a woman who had a racing pulse. Her body was in shock with dangerously low blood pressure. But it was her massive loss of blood that received the ER team's urgent attention. The woman was severely hemorrhaging from what appeared to be either a botched surgical abortion or a miscarriage.

It was neither. The patient's husband quickly informed Louviere that she was part of a clinical trial of RU-486, the French abortion pill, through Planned Parenthood in Des Moines. The woman had lost over half of her blood, and Louviere immediately took her into surgery for treatment. After two days of recovery and the transfusion of four units of blood, the woman went home, shaken, but with no long-term complications.

Such rare but harrowing cases may decide the final fate of RU-486, which the U.S. Food and Drug Administration (FDA) approved last fall as "safe and effective." While the sole American distributor, Danco Laboratories, reports heavy initial demand, abortion-pill critics seek to impose distribution restrictions that the FDA examined but declined to adopt. Ultimately, they hope that the new administration of President Bush, which is sympathetic to prolife concerns, will halt the drug's use over safety concerns.

"Regardless of whether you're prochoice or prolife, there are some significant public-health concerns related to the approval and use of this," says W. David Hager, M.D., director of the Women's Care Center of Lexington, Kentucky, and a professor in the Department of Obstetrics and Gynecology ...

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