- The Washington Times - Wednesday, November 23, 2005

Federal health officials are investigating the safety of a widely used abortion pill, after five women — four Americans and one Canadian — died of the same rare bacterial infection within days of taking the drug.

The deaths of the five women after undergoing early chemical abortions using mifepristone — marketed as Mifeprex and formerly known as RU-486 — in combination with a second drug called misoprostol, are not new. They began in 2001, continued through May of this year and have been publicized.

But the fact that all five women suffered from a rare and highly lethal bacterial infection known as Clostridium sordellii, which infiltrated the uterus and then spread to the bloodstream, was only recently determined, said to a spokeswoman for Danco Laboratories, which manufactures mifepristone. The abortion pill has been approved in this country since 2000 and in France since 1988.

In an announcement last July, the Food and Drug Administration (FDA) said four U.S. women — all of whom lived in California — died from infections after using mifepristone and misoprostol in abortions. But, at that time, the specific infection had not been identified in two of the four women.

Those two cases continued to be investigated by the FDA, the federal Centers for Disease Control and Prevention (CDC), Danco Labs and state and local health departments, until it was concluded that those women also died from infection with Clostridium sordellii.



So now the FDA and CDC want to find out whether mifepristone and/or misoprostol somehow make women vulnerable to this deadly bacterium. They will convene a scientific meeting next year to investigate.

Warnings about mifepristone’s possible link with Clostridium sordellii were added to the drug’s label in July.

The manufacturer defended its product’s safety.

“Over 500,000 women in the United States have taken mifepristone, [in combination with misoprostol] and, in Europe, about 1 million women have done so,” Danco spokeswoman Cynthia Summers said yesterday. “There’s no reason to believe either drug is responsible for these infections.”

But some medical research has suggested mifepristone alone was the cause of the deadly infections in the pregnant women, who died five to seven days after taking the abortion pill. Clostridium sordellii is a particularly troublesome bacterium, since it can live and grow in the absence of oxygen.

In a report in the Annals of Pharmacotherapy, Dr. Ralph P. Miech, a Brown University professor, found that mifepristone causes cervical changes that permit the uterus to be contaminated with Clostridium sordellii, a bacterium present in 10 percent of women.

Dr. Miech concluded that the drug “causes a malfunction of the innate immune system and its ability to fight the invasion by Clostridium sordellii.”

“Septic shock results,” he wrote.

Monty Patterson of Livermore, Calif., whose 18-year-old daughter, Holly, died in September 2003, a week after taking mifepristone, says he is convinced the abortion drug impairs the immune system. He wants it taken off the market.

Asked why more women have not been infected with Clostridium sordellii after taking the drug, Mr. Patterson said: “Peoples’ immune systems are not equal. But women are playing Russian roulette when they take this drug.”

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