Federal drug regulators are reviewing safety data on the abortion pill, Mifeprex or RU-486, after learning that all four women in the U.S. who died after taking it had suffered from a deadly bacterial infection.
After finding that the pills were not contaminated, the New York Times reports, the FDA and the CDC are planning to meet early next year to discuss whether the pills might make patients vulnerable to infection with Clostridium sordellii.
The review was ordered after persistant lobbying by family members of the dead women.
Monty Patterson, whose daughter Holly died on Sept. 17, 2003, less than a month after her 18th birthday, said he believed that Mifeprex inhibits the immune system, making women more vulnerable to bacteria.
Mr. Patterson's campaign against Mifeprex helped persuade the family of at least one other woman who died to have tissue samples tested for the presence of the rare bacteria, he said.
"I believe this drug should be taken off the market," Mr. Patterson said.
For now, there is no indication that the FDA is considering restricting access to the drug. It advises doctors against giving antibiotics as a precaution to prevent the rare infections since antibiotic therapy carries its own risks.
Mifeprex has been used in more than 500,000 medical abortions in the United States since its approval in September 2000. The risks of death from infection after using the pill are similar to the risks after surgical abortion or childbirth. said Dr. Steven Galson, director of the FDA's center for drugs.
Warnings about the drug's possible link with Clostridium sordellii were placed on Mifeprex's label in July, and the FDA updated the information on its Web site on Nov. 4 after it discovered that all of the deaths involved the lethal bacteria.
"I think everyone would like to know what exactly is going on regarding these rare and really serious Clostridium sordellii infections that we have seen happen in California," said Dr. Cynthia Summers, a spokeswoman for Danco Laboratories, maker of Mifeprex, told the Times.
"I don't have an answer for you, and because of that I don't have any running theories."
Clostridium sordellii infected the women's uteruses, and then entered their bloodstreams. The bacterium can cause nausea, vomiting, diarrhea and weakness but may not induce fever, so victims often fail to realize how sick they are until it is too late and succumb to toxic shock. Antibiotics are often ineffective once an infection has flourished because even in death, the bacteria release toxins.
No similar deaths have been reported in Europe, where Mifeprex is widely used. But in the United States, most physicians give Mifeprex and an accompanying drug, misoprostol, in a regimen that involves inserting misoprostol vaginally.
Federal drug regulators have not approved this regimen, but it is not unusual for doctors to use drugs differently from how they are officially approved. Studies indicate that this regimen is effective, requires a lower dose of misoprostol, and allows women to undergo the most emotional and painful part of the procedure at home. What is unknown is whether it may somehow contribute to bacterial infections.
Any hint that Mifeprex may cause problems usually leads to a firestorm of criticism directed at the F.D.A., and the meeting scheduled for next year is bound to incite controversy. A 1996 federal advisory committee that recommended the drug's approval met under intense security in a windowless building surrounded by federal marshals.
Wendy Wright, executive vice president of Concerned Women for America, a conservative group, said that the latest news about deaths involving Mifeprex proved that the drug was unsafe. Ms. Wright also speculated that more women were dying after using the drug but that their deaths were going unreported.
"I'm pleased that the FDA is taking a serious look at this," she told the Times, "and hope that they will no longer allow this drug to be available to cause the deaths of more women."
Dr. Scott J. Spear, chairman of the national medical committee of the Planned Parenthood Federation of America, the nation's largest provider of abortions, said there was no evidence that the vaginal administration of misoprostol increased the risks of bacterial infections.
"They're all in California, so is this a local issue?" Dr. Spear said. "I think it's dangerous to speculate in the absence of good data."
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