Tags: Doctor | Claims | RU-486 | Can | Cause | Lethal | Septic

Doctor Claims RU-486 Can Cause Lethal Septic Shock

Thursday, 04 August 2005 12:00 AM

In mid-July, the Federal Drug Administration (FDA) issued a public health warning regarding RU-486 following the report from Mifeprex drug maker Danco Laboratories that five women in the U.S. and Canada had died since 2000 due to serious bacterial infection. In at least three of the cases, the bacteria Clostridium sordellii caused the septic shock.

Miech told Cybercast News Service that he is certain "it is the RU-486 that weakens the innate immune system that allows the bacteria to grow and multiply and secrete its toxins and cause septic shock."

Danco, however, issued a statement in July, insisting that "no causal relationship between these events and the use of Mifeprex and misoprostol has been established."

"This is one of the things that is very peculiar," said Miech. "They [Danco] say that septic shock has been reported but they also further go on to say that there is no causal relationship. This is one of the reasons why I decided to write the paper, to look and see. It took quite a bit of research to come up with the theory of how this is related, how the drug is related to allowing the bacteria to grow, secrete its toxins and cause septic shock."

The Annals of Pharmacotherapy summarized Miech's findings.

Mifepristone opens up the cervix, which "permits contamination of the uterus with Clostridium sordellii, a bacterium that is part of the normal vaginal flora in about 10 percent of women ... mifepristone causes a malfunction of the innate immune system and its ability to fight the invasion by Clostridium sordellii," the magazine stated.

Often, women are prescribed medicine with codeine for pain during their abortions. "Mifepristone and codeine interact, resulting in prolonged effects of both drugs. Because mifepristone's action then lasts longer, the body's ability to fight the Clostridium sordellii invasion may be lessened," the summary noted.

Dr. Cynthia Summers, director of marketing and public affairs for Danco Laboratories, told Cybercast News Service that Miech's findings were not supported by facts.

"Given that: (1) approximately 2 million women in Europe and the United States have used the mifepristone and misoprostol regimen for early abortion; and (2) reports of any infection are very infrequent: approximately 13 out of 100,000 women in the United States, the proposed theories are not supported by the facts. That is, one would expect to see a much higher rate of all kinds of infections in women using the Mifeprex regimen."

Miech replied that many infections are not reported. "The question is whether or not the women actually already have antibodies against Clostridium sordellii." Women who have the antibodies have "the means of getting rid of the infection," he said. "But if they don't have any antibody protection against Clostridium sordellii," then the chances of septic shock increase.

Summers noted that "childbirth, menstruation, and abortion (whether spontaneous, surgical or medical) all create conditions that can result in infection." But Miech disputed this point as well, stating that "so far, none of these cases of infection with Clostridium sordellii have been reported with surgical abortions."

Danco is standing by its product, insisting that "there is no medical evidence to suggest that the Mifeprex regimen - a combination of mifepristone followed by misoprostol - presents an increased risk of infection or death and no causal relationship has been established," Summers concluded.

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In mid-July, the Federal Drug Administration (FDA) issued a public health warning regarding RU-486 following the report from Mifeprex drug maker Danco Laboratories that five women in the U.S. and Canada had died since 2000 due to serious bacterial infection. In at least...
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Thursday, 04 August 2005 12:00 AM
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