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:
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All providers of medical abortion and emergency room health care providers should investigate the possibility of sepsis in patients who are undergoing medical abortion and present with nausea, vomiting, or diarrhea and weakness with or without abdominal pain, and without fever or other signs of infection. To help identify those patients with hidden infection, strong consideration should be given to obtaining a complete blood count.
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FDA recommends that physicians suspect infection in patients with this presentation and consider immediately initiating treatment with antibiotics that includes coverage of anaerobic bacteria such as Clostridium sordellii.
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At this time FDA does not have sufficient information to recommend the use of prophylactic antibiotics. Reports of fatal sepsis in women undergoing medical abortion is very rare (approximately 1 in 100,000). Prophylactic antibiotic use carries its own risk of serious adverse events such as severe or fatal allergic reactions. Also, prophylactic use of antibiotics can stimulate the growth of “superbugs,” bacteria resistant to everyday antibiotics. Finally, it is not known which antibiotic and regimen (what dose and for how long) will be effective in cases such as the ones that have occurred.
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The approved Mifeprex regimen for a medical abortion through 49 days’ pregnancy is:
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Day One: Mifeprex Administration: 3 tablets of 200 mg of Mifeprex orally at once
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Day Three: Misoprostol Administration: 2 tablets of 200 mcg of misoprostol orally at once.
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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.
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The safety and effectiveness of other Mifeprex dosing regimens, including use of oral misoprostol tablets intravaginally has not been established by the FDA.
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 http://www.fda.gov/cder/drug/infopage/mifepristone/default.htm
FDA will update this advisory as more definitive information becomes available.
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1 posted on
07/21/2005 3:19:43 PM PDT by
Coleus
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)
To: Coleus
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]
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
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]
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]
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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