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Abortion Drug Adverse Events Reported

Reports Include Infection and Severe Bleeding

Calls for More Research

Another problem, she says, is that even when women seek treatment their medical problem may not be recognized as being related to use of the drug. Early symptoms of drug-related bacterial infection often include abdominal cramping, nausea and vomiting. These symptoms are common among women who take the abortion drug.

Gary and Harrison are calling for increased research into allergic and fatal infection complications associated with the use of the abortion drug, and they are urging the FDA to do a better job of recording adverse events associated with its use.

"If our survey of (this drug's) adverse event reports is representative of adverse event reporting for all drugs, the American public should be greatly alarmed," they wrote. "The deficiencies were so egregious in some instances as to preclude analysis."

Harvard Medical School obstetrics and gynecology professor Michael F. Greene, MD, tells WebMD that underreporting of adverse events may be less of a problem with RU-486 than with many other drugs because there is so much scrutiny of its use.

He does agree, however, that questions remain about the safety of the abortion drug. He says it is not clear if the drug is safer or less safe than spontaneous abortion (miscarriage) or surgical abortion, or whether the deaths and other reported adverse events were caused by the drug.

Last July, the FDA announced that it would require Danco Laboratories to include a warning about possible bacterial infection on the drug's packaging.

Greene says the research done to date on RU-486 cannot adequately "address the issue in a scientifically rigorous way."

"I don't have a dog in this fight," he says. "But I do believe very strongly that women should have access to safe pregnancy termination rather than being forced to undergo unsafe pregnancy termination. If the safest way of terminating a pregnancy turns out to be surgical, then so be it. But until we have more compelling data, no one should leap to conclusions."

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