Different River

”You can never step in the same river twice.” –Heraclitus

November 24, 2005

Will the FDA pull a drug that kills women?

Filed under: — Different River @ 5:34 pm

Not if NOW or Planned Parenthood has its way.

It seems that Mifeprex (the “abortion pill” also known as “RU-486″ and “mifepristone”) has been killing women. No, not just the fetal women (and men) it was designed to kill, but the women who take it. As the New York Times reports (emphasis added):

[F]our women in this country who died after taking an abortion pill suffered from a rare and highly lethal bacterial infection, a finding that is leading to new scrutiny of the drug’s safety.

Since all four deaths occurred in California, an unusual clustering, the Food and Drug Administration quietly tested to see if abortion pills distributed in California were somehow contaminated. They were not.

Stumped, officials from the F.D.A. and the federal Centers for Disease Control and Prevention have decided to convene a scientific meeting early next year to discuss this medical mystery, according to two drug agency officials who spoke on the condition of anonymity because of the sensitivity of the topic.

Among other issues, the experts hope to explore whether the abortion pill, called Mifeprex or RU-486, somehow makes patients vulnerable to an infection with Clostridium sordellii, the lethal bacteria. If so, they will explore how such an infection “could be more easily diagnosed and even prevented,” one official said.

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 F.D.A. is considering restricting access to the drug. Indeed, it has advised 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 F.D.A.’s center for drugs.

Warnings about the drug’s possible link with Clostridium sordellii were placed on Mifeprex’s label in July, and the drug agency without announcement updated this information on its Web site on Nov. 4 after it discovered that all of the deaths involved the lethal bacteria.

Ms. Patterson died seven days after taking Mifeprex. She lived in Livermore, Calif.

On Dec. 29, 2003, Vivian Tran, 22, of Costa Mesa, Calif., died six days after taking Mifeprex.

On Jan. 14, 2004, Chanelle Bryant, 22, of Pasadena, Calif., died six days after taking Mifeprex. And on May 24, 2005, Oriane Shevin, 34, of Los Angeles died five days after taking Mifeprex.

In each case, Clostridium sordellii infected the women’s uteruses, flourished 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.

The families of Ms. Patterson, Ms. Tran and Ms. Bryant have all filed suit against Danco, claiming the company failed to warn patients of the drug’s dangers.

A woman who died in Canada after taking Mifeprex during clinical testing in 2001 also suffered from a Clostridium sordellii infection. …

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 F.D.A. is taking a serious look at this,” she said, “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.

No, four dead women is “no evidence” when a political drug is involved. It only took three deaths to get Vioxx off the market, and that was a drug given to millions more people, mostly older people who have a greater risk of death than 18- to 22-year-old women, even in the absense of any drug. And there is no known mechanism by which Vioxx can cause death either.

One might ask, if there’s a problem with Mifeprex, why didn’t the FDA find it in testing? The reason is, Mifeprex was exempted from the usual standards the FDA uses to approve drugs. First, on his third day in office, President Clinton issued an executive order directing the Secretary of Health and Human Services to allow the importation of the drug for personal use, and to “promptly” “promote” the manufacture of the drug in the United States:

I direct that you immediately take steps to rescind Import Alert
66-47 [which barred the importation of unapproved RU-486].

In addition, I direct that you promptly assess initiatives by which the Department of Health and Human Services can promote the testing, licensing, and manufacturing in the United States of RU-486 or other antiprogestins.

Of course, we all “know” it was pure coincidence that the FDA gave its preliminary approval (subject to resolving labelling issues) in September 1996, during a presidential campaign, and final approval in September 2000, during the next presidential campaign.

You might think that the National Organization for Women might be interested in investigating the safety of this drug that kills only women. But you would be wrong — they are focusing their FDA-lobbying efforts on preventing women from exercising their right to control their own bodies. (See my previous post on that topic.)

One Response to “Will the FDA pull a drug that kills women?”

  1. Antibiotic Birth Control Pill Says:

    I was searching for ‘antibiotic birth control pill’ at google and got this your post (‘Will the FDA pull a drug that kills women?’) in search results. Not very relevant result, but still interesting to read :)

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