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FDA warns again of abortion pill risk
Medical News Today ^ | 07.21.05

Posted on 07/21/2005 3:19:42 PM PDT by Coleus

FDA Issues Health Advisory for Mifepristone Citing Four Sepsis-Related Deaths Among Users; Drug Labeling To Be Updated

21 Jul 2005alt

FDA on Tuesday issued a... public health advisory warning physicians to watch for any signs of sepsis or other infection among women who have taken Danco Laboratories' Mifeprex -- known generically as mifepristone -- which when taken with misoprostol can cause a medical abortion, the AP/Seattle Post-Intelligencer reports. The agency is investigating four sepsis-related deaths among women who took the drug, including two cases reported to FDA in April and June (Neergaard, AP/Seattle Post-Intelligencer, 7/20). Physicians have identified the bacterium Clostridium sordelli -- a common germ not usually associated with illness -- as the cause of two of the four deaths and suspect it as the cause of the other two deaths, the San Francisco Chronicle reports. Steven Galson, acting director of FDA's Center for Drug Evaluation and Research, said it is not clear why the bacteria became fatal in the women (Barnum, San Francisco Chronicle, 7/20). Galson said the four deaths all occurred in women who did not follow FDA-approved instructions for using the drug. According to the directions, women should take both mifepristone and misoprostol orally, but some clinics instruct patients to insert misoprostol vaginally. Galson said it is unclear if such off-label use of the drug led to the deaths (AP/Seattle Post-Intelligencer, 7/20).

FDA Advisory
FDA has advised doctors to prescribe antibiotics immediately to women who have taken mifepristone and who have symptoms of Clostridium sordelli infection, including nausea, vomiting, diarrhea and weakness, Galson said. However, the agency advises against prescribing antibiotics to all patients who use mifepristone because the risk associated with antibiotic use outweighs the very low risk of bacterial infection, according to Galson (Harris, New York Times, 7/20). Galson said there has been less than one infection per 100,000 users of mifepristone, adding, "There are no alarm bells going off because of this rate. But we are watching very closely" (San Francisco Chronicle, 7/20).

Danco To Change Mifeprex Label
Eight months after FDA ruled that the labeling of Mifeprex should be revised to warn users of the possibility of bacterial infection and other complications, Danco on Monday announced it will modify the drug's label to reflect updated safety information, the Contra Costa Times reports (Brewer, Contra Costa Times, 7/19). The Mifeprex packaging already includes a warning stating that women who use the drug could experience serious and possibly fatal infections. The updated information will give physicians more information so they can identify problems earlier, according to Danco spokesperson Cynthia Summers. Danco also plans to send a letter to physicians and emergency department directors to inform them of the updated warning and five known deaths -- four of which were sepsis-related -- among users of Mifeprex (Reuters AlertNet, 7/18). FDA approved Mifeprex in 2000 for the termination of early pregnancy, defined as 49 or fewer days gestation (Kaiser Daily Reproductive Health Report, 11/18/04).

"Reprinted with permission from You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at The Kaiser Daily Health Policy Report is published for, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

TOPICS: Business/Economy; Culture/Society; Government; News/Current Events
KEYWORDS: abortion; abortiondeaths; abortionlist; abortionpill; catholiclist; chemicalabortion; clostridiumsordelli; danco; deaths; fda; federalgovernment; infection; mifeprex; misoprostol; ru486; sepsis; septicshock; warning; wod; wodlist

FDA Public Health Advisory
Sepsis and Medical Abortion

The Food and Drug Administration (FDA) is aware of four cases of septic deaths in the United States, from September 2003 to June 2005 in women following medical abortion with mifepristone (Mifeprex) and misoprostol. The bacteria causing sepsis has been identified in two of the cases as Clostridium sordellii. The other two cases are under ongoing investigation by FDA along with the Centers for Disease Control and Prevention, State and local health departments, and the manufacturer of Mifeprex. All cases involve the off-label dosing regimen consisting of 200 mg of oral Mifeprex followed by 800 mcg of intra-vaginally placed misoprostol. The two confirmed cases of Clostridium sordellii did not have the usual signs and symptoms of an infection. Although these deaths are reported from California, all providers of medical abortion and their patients need to be aware of the risks of sepsis. As more information becomes available, FDA will alert the public.

In the meantime, FDA recommends that healthcare professionals and patients be aware of the following:

These recommendations are consistent with warnings in the Prescribing Information and information for the patient in the Medication Guide.

FDA is also working with the manufacturers of Mifeprex and misoprostol tablets to conduct special tests to ensure that there was no contamination of either product with Clostridium sordellii.

Information pertaining to Mifeprex can be found at

FDA will update this advisory as more definitive information becomes available. 

Back to Top     Back to Mifeprex

1 posted on 07/21/2005 3:19:43 PM PDT by Coleus
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UN Health Agency Adds Abortion Drugs to 'Essential Medicines' List

Teen Death Steers RU-486 Bill to Congress
Ads for Controversial Abortion Pill Set to Appear in National Magazines

Meet The Man Pouring Millions Into Population Control: Warren E Buffett

US Embassy Beijing: Report: Family Planning in China: RU486
Doctors let 50 women abort babies at home [Scotland]
Jesus and the FDA

2 posted on 07/21/2005 3:20:57 PM PDT by Coleus ("Woe unto him that call evil good and good evil"-- Isaiah 5:20-21)
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To: Coleus

I beat them by 5 years!

3 posted on 07/21/2005 3:22:56 PM PDT by G Larry (Honor the fallen and the heroes of 9/11 at the Memorial Site.)
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To: Coleus
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1: J Trauma. 1975 Jun;15(6):515-8. Related Articles,

Clostridium sordelli infection.

Browdie DA, Davis JH, Koplewitz MJ, Corday L, Leadbetter AW.

A case of human Clostridium sordelli soft tissue infection is presented. Analysis of this patient's course led to the use of a mouse experimental model for examination of this organism's potential for toxin production. Data thus obtained correlated with that seen in this instance of human infection, indicates that the lethal effects of this organism may be related to the ability to Clostridium sordelli to produce a widespread "toxin-mediated" edema with subsequent marked "third-space" sequestration of fluid.

Publication Types:
  • Case Reports

PMID: 1127784 [PubMed - indexed for MEDLINE]

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4 posted on 07/21/2005 3:49:16 PM PDT by aposiopetic
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To: Coleus
Med Microbiol Immunol (Berl). 1975 Jul 2;161(3):145-54.

Extracellular proteins in five clostridial species from human infections.

Nord CE, Wadstrom T, Dornbusch K, Wretlind B.

347 strains from human infections were identified by gas-liquid chromatography of metabolic products and by conventional tests. Simple agar-plate assays were used to analyze the ability to form extracellular proteins. More than 90% of all strains were hemolytic on agar containing rabbit erythrocytes and all were gelatinase producers. All strains of C. bifermantans, C. sordelli, and C. sporogenes were also caseinolytic on skimmed-milk agar, but strains of C. perfringens, C. novyi types A and B were not. Less than 10% of C. perfringens strains were producers of elastase and staphylolytic enzyme and all other species were non-producers. All C. perfringens, C. novyii, C. bifermentans, and C. sordelli were lecithinase producers, but C. sporogenes was not. All strains of C. sporogenes formed deoxyribonuclease, while a varying number of the other species showed a positive reaction.

PMID: 170498 [PubMed - indexed for MEDLINE]

5 posted on 07/21/2005 3:53:47 PM PDT by aposiopetic
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To: Coleus

Class action against makers of Ru-486?

Now we'll see what these proaborts really think of women as they come out and oppose the suit.

Abortionists are the death camp commandants of the 20th century.

6 posted on 07/21/2005 3:55:47 PM PDT by TFMcGuire
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To: Coleus
Am J Clin Pathol. 1989 Jan;91(1):104-6.

Erratum in: Am J Clin Pathol 1989 Jul;92(1):128.

Fatal acute spontaneous endometritis resulting from Clostridium sordelli.

Hogan SF, Ireland K.

Department of Pathology, Good Samaritan Hospital, Corvallis, Oregon 97339.

Intrauterine clostridial infections have historically been associated with puerperal sepsis, often subsequent to instrumented abortions. Isolated reports have been associated with a malignant neoplasm or degenerating leiomyoma, most often after instrumentation, radiation therapy, or chemotherapy. In these cases, well-known risk factors or obvious niduses for growth and causation of disease were identified. The authors report a case of fatal spontaneous endometritis resulting from Clostridum sordellii, which, to their knowledge, has not been previously reported in the literature. Characteristics of this rare virulent human pathogen are discussed.

Publication Types: Case Reports

PMID: 2910010 [PubMed - indexed for MEDLINE]

7 posted on 07/21/2005 3:56:38 PM PDT by aposiopetic
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To: Coleus
J Vet Intern Med. 1997 Nov-Dec;11(6):319-22.

Prevalence and identity of translocating bacteria in healthy dogs.

Dahlinger J, Marks SL, Hirsh DC.

Department of Surgical and Radiological Sciences, School of Veterinary Medicine, University of California, Davis 95616, USA.

Bacterial translocation is characterized by the passage of intestinally derived bacteria across the intestinal mucosa to local or regional tissues. This phenomenon is believed to be important in the pathogenesis of gram-negative bacteremia and septicemia; however, the pathway or route of translocation remains unclear. To define the route of translocation better, mesenteric lymph nodes from 50 apparently healthy dogs undergoing elective ovariohysterectomies were cultured aerobically and anaerobically. The aims of this study were to determine the prevalence of bacterial translocation and to quantify and identify types of organisms found in mesenteric lymph nodes. Peripheral blood and portal blood samples were similarly cultured to rule out hematogenous organisms as a source of lymph node contamination. Bacteria were isolated from mesenteric lymph nodes of 26 dogs (52%). The number of bacteria varied from 50 to > 10(5) organisms/g of tissue. Bacteria isolated included Staphylococcus intermedius (n = 3), coagulase-negative Staphylococcus (n = 2), nonhemolytic Streptococcus (n = 4), Bacillus species (n = 5), Escherichia coli (n = 6), Salmonella species (n = 3), Pseudomonas species (n = 2), Enterococcus species (n = 2), Clostridium sordelli (n = 1), Micrococcus species (n = 1), Lactobacillus species (n = 1), and Propionibacterium acnes (n = 1). One of 50 peripheral blood samples yielded an unidentified gram-positive coccus and a coagulase-negative Staphylococcus. No bacteria were isolated from portal blood samples of any dog. Further studies of this type on sick dogs are warranted before clinical recommendations can be made to culture mesenteric lymph nodes routinely.

PMID: 9470154 [PubMed - indexed for MEDLINE]

8 posted on 07/21/2005 4:00:03 PM PDT by aposiopetic
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To: Coleus
"Day 14: Post-Treatment: the patient must return to confirm that a complete termination has occurred. If not, surgical termination is recommended to manage medical abortion treatment failures."

Translation: If the baby is too strong to be poisoned and killed, suck it out piece-by-piece with a vacuum!

9 posted on 07/21/2005 4:11:18 PM PDT by varyouga
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To: 2ndMostConservativeBrdMember; afraidfortherepublic; Alas; al_c; american colleen; annalex; ...

10 posted on 07/21/2005 9:16:16 PM PDT by Coleus ("Woe unto him that call evil good and good evil"-- Isaiah 5:20-21)
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William J. Clinton, "Memorandum for the Secretary of Health and Human Services; Subject: Importation of RU-486," January 22, 1993.

Why can't "W" do the same and reverse the order by using executive fiat as Clinton did?
11 posted on 07/21/2005 9:22:08 PM PDT by Coleus ("Woe unto him that call evil good and good evil"-- Isaiah 5:20-21)
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To: TFMcGuire

"Class action against makers of Ru-486?"

Looks like it could very well be in the future.

12 posted on 07/21/2005 9:26:02 PM PDT by Sun (Call U.S. senators toll-free, 1-877-762-8762; tell them to give Roberts an up or down vote.)
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To: Coleus

"William J. Clinton, "Memorandum for the Secretary of Health and Human Services; Subject: Importation of RU-486," January 22, 1993.

Why can't "W" do the same and reverse the order by using executive fiat as Clinton did?"

Good point.

I wish a pro-life organization would get thousands of people to contact Bush about this.

13 posted on 07/21/2005 9:28:02 PM PDT by Sun (Call U.S. senators toll-free, 1-877-762-8762; tell them to give Roberts an up or down vote.)
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