Abortion Drug Adverse Events Reported
Reports Include Infection and Severe Bleeding
Deaths Under Investigation continued...
The findings were reported online Wednesday, and will be published in the February 2006 issue of The Annals of Pharmacotherapy.
Researcher Margaret M. Gary, MD, tells WebMD that she believes the adverse reactions reported to the FDA make up only a fraction of the true medical events that actually occur among women who take the drug to induce abortions.
Gary and co-author Donna J. Harrison, MD, are with the American Association of Pro Life Obstetricians and Gynecologists, a group that has long called for the removal of RU-486 from the market.
"The FDA reports that only about 1% to 10% of adverse events for any given drug are ever reported," she says. "And in this case women may be even less likely to report problems because they may be ashamed."
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.