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Government Issues New RU-486 Warnings

Doctors and Patients Alerted to Bleeding, Infection, Death
WebMD Health News

Nov. 16, 2004 -- The FDA has strengthened warning labels for the controversial abortion pill Mifeprex, better known as RU-486, following an August report of a 22-year-old woman who died after taking the drug.

The agency released new alerts warning doctors and patients of a risk of severe bacterial infections and heavy bleeding associated with RU-486. The drug's distributor is also changing its label to remind doctors that the drug should not be prescribed to women who have ectopic pregnancies, which are pregnancies that develop in the fallopian tubes instead of the uterus.

Danco Laboratories, which markets and distributes RU-486 under the brand name Mifeprex, reported to FDA officials in August that they received a report of a California woman who died of a widespread bacterial infection while trying to medically terminate a seven-week pregnancy in January.

The report was the third reported in the U.S. since the drug went on the market in 2000. An 18-year-old San Francisco woman died of a similar infection after taking RU-486 in September 2003. A 38-year-year old woman died in 2001 after taking the drug during an ectopic pregnancy.

FDA officials say complications with RU-486 remain rare and that they have no evidence directly connecting it to any of the deaths, but they want doctors and patients to be aware of the risk of infection or heavy bleeding.

"We have not been able to link any of them in terms of the drug causing the event," says Steven Gallson, MD, acting director of the agency's Center for Drug Evaluation and Research.

RU-486 was approved under the brand name Mifeprex in 2000, more than four years after an FDA advisory panel recommended its clearance. The drug has remained at the center of the U.S. abortion debate.

Gallson says the FDA's decision to strengthen safety warnings connected to RU-486 was based on scientific concerns and that Bush administration officials did not try to influence the decision. "There was absolutely no political pressure on this. This was a science-based decision," he says.

RU-486 is approved for the termination of normal pregnancies seven weeks or less in duration, but the drug is commonly used to terminate longer-term pregnancies.

More than 360,000 women have taken RU-486 since 2000, according to Danco. Regulators have received more than 600 reports of adverse events in women taking RU-486 but stress that those reports do not prove that RU-486 caused the events.

Still, officials say they grew concerned that doctors and patients needed more information warning that infection or severe bleeding can occur.

Some women taking RU-486 don't seek medical attention for severe bleeding or cramping since those symptoms almost always occur, says Phillip G. Stubblefield, a professor of obstetrics and gynecology at Boston University School of Medicine who has researched medical abortion and its potential complications.

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