The cause of increasing rare but deadly bacterial infections, including a handful of cases in women who have taken the controversial RU-486 abortion pill, is still unclear and needs further study, U.S. health experts said on Thursday.
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Two sometimes fatal bugs — Clostridium sordellii and Clostridium difficile — are a particular worry as antibiotic resistance grows and infections occur in people usually not at risk, doctors and researchers said.
While infections have been reported in drug users, surgical patients and accident victims, including men, cases in women who took RU-486 drew the most scrutiny at the Centers for Disease Control and Prevention’s Atlanta headquarters.
Officials from the CDC, Food and Drug Administration and National Institutes of Health sought input from outside experts on what research and tracking systems are needed.
Paul Seligman, FDA associate director for safety policy, said it was not clear what is causing the spike.
“What we do know is that in this country we are seeing the simultaneous emergence of two virulent, often fatal illnesses affecting otherwise healthy people,” he said.
More than 200,000 Clostridium difficile cases occur each year in the United States, experts said. The diarrhea-causing disease is usually manageable but has recently become more difficult to treat.
Clostridium sordellii is far more rare and previously was not known to be toxic. “Over the past few years the picture has changed,” Seligman told the panelists.
Drawing the most scrutiny were cases involving RU-486.
The drug, made by Danco Laboratories LLC, is taken with another called misoprostol early in pregnancy to trigger an abortion. It is not related to emergency contraception.
Six women who took RU-486, also known as Mifeprex or mifepristone, have died since 2000. Four died from Clostridium infection, one was ruled unrelated, and the other is still being investigated. Officials have not directly linked the deaths to the drug.
The CDC on Thursday said it was investigating another fatal case involving a woman who took misoprostol as part of an abortion procedure. Another fatal infection following medical abortion has yet to be confirmed.
Ten other deadly infections have been reported in women who had given birth or who had miscarriages.
Several women’s groups and others RU-486 supporters said the infections needed more study, while abortion opponents said the data showed the pill was too risky to stay on the market.
Monty Patterson, whose daughter Holly died from an infection after taking the drug and is the namesake of a U.S. bill to ban it, called for research to “explore the possible causal relationship.”
Two experts also questioned the pill. University of Colorado Health Sciences Center gynecologist James McGregor urged officials to “reduce or eliminate” Mifeprex use.
Overall, panelists encouraged further study, especially on women. “We clearly need controlled trials,” said Dale Gerding of Hines Veterans Affairs Hospital in Illinois.
Most also said limited government data made tracking infections tough and urged better reporting systems.
It was not immediately clear what action the FDA might take regarding RU-486 or if officials would suggest use of antibiotics to prevent infection.
FDA’s Deputy Director of the Office of New Drugs Sandra Kweder said the meeting showed “the picture is much more complicated” than the cases involving the abortion pill.
“This is a far more complex medical and epidemiological situation than originally might have appeared to be the case, and we’ll be trying to factor that into any actions that we take,” she said afterward.
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