PHILADELPHIA – Federal scientists investigating the sudden deaths of four young, healthy California women who used the abortion pill have found that a rare bacterial infection killed all four.
Scientists do not know how – or how often – this dire complication is linked to the abortion pill Mifeprex, also called mifepristone or RU-486. It has been used by 508,000 women in the United States since its approval five years ago. The Food and Drug Administration plans to meet with experts early next year to consider what to do next.
In July, the FDA revised the Mifeprex label – for the second time in eight months – to warn of symptoms of infection with the bacteria, called “Clostridium sordellii.” By then, the microbe had been confirmed in two of the California deaths and a similar fatality in Canada.
“The first, most important thing is to get a handle on how often” the infection occurs, said government epidemiologist Marc Fischer, lead author of an article on the cases published in today’s New England Journal of Medicine. “What we’re really asking is for physicians to report any similar cases.”
But the political and economic fallout may come before answers to the medical mysteries.
Abortion foes, who have pushed for withdrawal of the product ever since its September 2000 approval, have seized on the latest safety concerns. In March, U.S. Sen. Jim DeMint, R.-S.C., introduced the RU-486 Suspension and Review Act, commonly known as “Holly’s Law” for 18-year-old Holly Patterson of Livermore, Calif., who died of a “sordellii” infection a week after using the pill in 2003.
Demand for Mifeprex, which accounts for only about 5 percent of abortions in the United States, may be dampened as doctors warn patients about the newly recognized infection risk. The FDA, Mifeprex manufacturer Danco Laboratories, and now the New England Journal have worked to publicize the risk while calling for more study.
Even if the risk of death from “sordellii” turns out to be only 1 in 100,000, judging the safety of the abortion pill will be complicated, Harvard University obstetrician-gynecologist Michael F. Greene wrote in an editorial in the journal. In comparison, a woman’s chance of dying from a pregnancy-related cause is about 10 times greater. But the chance of dying of a surgical abortion in early pregnancy – when the abortion pill may be used – is 10 times less, he wrote.
Although the microbe is rarely found in the female genital tract, 10 cases of fatal “sordellii” infection – nine after pregnancy or abortion – have been reported in medical journals.
It is not clear whether the infection could be treated with antibiotics if detected in time. Patients have no fever, and the bacteria quickly unleash untreatable toxins that cause a toxic-shock-like syndrome – lethally low blood pressure, leaky blood vessels, and an explosion in white blood cells that mimics leukemia.
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