Even before mifepristone was approved by the Food and Drug Administration in 2000, anti-abortion groups had lobbied to keep what they called a “chemical coat hanger” off the market. When the FDA approved it anyway, opponents warned it was unsafe. But so far, of the more than 200,000 American women who have taken the drug, less than 0.2 percent reported “adverse events” of any kind to the FDA. Last year, after the drug’s maker, Danco, sent a warning letter to doctors detailing a handful of serious complications–including hemorrhaging and bacterial infections–three conservative groups filed a citizens’ petition with the FDA to pull the drug off the market.
Patterson wasn’t the only woman to suffer complications after taking mifepristone. In the fall of 2001, a Tennessee woman, Brenda Vise, took the pill and died after it turned out she had an ectopic, or tubal, pregnancy that ruptured. Danco warns that the pill should not be used to end ectopic pregnancies, which can be fatal if not properly treated. Vise’s family is suing her clinic and doctors, but not Danco. Californian Danlin Tang took RU-486 in May 2002 and later landed in the intensive-care unit with a massive infection and bleeding so intense she needed blood transfusions. “I almost died from this pill,” she said in Chinese through an interpreter. Tang and her husband have also filed suit against her doctors and clinic, but not Danco.
Though cases like these are disturbing, mifepristone has a lower complication rate overall than surgical abortion or even childbirth. “It’s a very safe and effective method,” says National Abortion Federation president Vicki Saporta. Because the drug requires thorough medical follow-up, it’s difficult to blame the pill–and not human error–for complications. The FDA says the citizens’ petition to recall RU-486 is “still under review.” But it’s unlikely the FDA would suddenly pull the drug off the market–the agency typically adds restrictions first. Even so, RU-486 opponents hope the Patterson case may provide one more reason to shelve the pill for good.