CDC NEJM Article Warns of Abortion Drug Risks
Italy Health Minister Stops RU-486 Abortion Drug Trials After Problems
RU-486 Maker Sued After 21-Year-Old Dies
FDA Issues Warning About Deadly Infections from Mifeprex Abortion Pill
Lawmakers want Mifeprex Pulled After More Women Die
RU 486 Has Caused Over 600 Adverse Effects in Addition to Deaths
Mifeprex is Mifepristone, or RU 486
Toxic Shock Syndrome After Medical (Chemical) Abortion
Pathophysiology of Mifepristone-Induced Septic Shock
CDC NEJM ARTICLE WARNS OF ABORTION DRUG RISKS. An article written by Centers for Disease Control officials [1Dec05 edition New England Journal of Medicine] warns women of the risks of fatal infections from the RU 486 abortion drug and asks doctors to be on the lookout for toxic shock related to the abortions.
The CDC authors point to the deaths caused by the fatal Clostridium sordellii bacteria that infected four California women who used the Mifeprex abortion drug.
The article noted that all of the women used one of the two-part drug process vaginally. FDA guidelines call for oral use, but Planned Parenthood abortion businesses, wanting to use the drug in lower doses, tell women to use it vaginally.
All 4 women were found to have the deadly bacterium in their uteruses. Marc Fischer, M.D., and his CDC colleagues said that all 4 women died one day after going to the hospitals with recent symptoms from the infections.
The women did not show normal infection telltale signs until it was too late. “The clinical and pathological findings in these cases are similar to those in 10 other cases of C. sordellii infection of the genital tract reported in the literature… Of the 10 previous cases that we identified, all occurred in previously healthy young women, and nine occurred within one week after delivery (8 women) or after abortion (1 woman),” they wrote in the NEJM.
One problem they noted is that the initial symptoms of the dangerous bacteria may show as normal side effects from using the abortion drug, such as cramping or abdominal pain.
The CDC authors urged doctors treating women with such symptoms to be on the lookout for toxic shock and they said women considering an RU 486 abortion should be informed of the risks. The article is important because it gives a glimpse about the direction the agency will pursue when it conducts a joint meeting with FDA officials early next year to probe how and why the women contracted the deadly infections from the abortion drug.
Wendy Wright [Concerned Women for America]: “The drug’s owner [Danco Labs] has only one product, so it has no incentive to pull the drug from the market. That’s why the FDA must act in the best interest of women’s health by pulling this drug from the market.” [The article reference is: Fischer M et al. Fatal Toxic Shock Syndrome Associated with Clostridium sordellii after Medical Abortion. N Engl. J Med 2005; 353:2352-60. Ertelt, LifeNews.com 1Dec05, D.C.]
ITALY HEALTH MINISTER STOPS RU 486 ABORTION DRUG TRIALS AFTER PROBLEMS. Italian Health Minister Francesco Storace suspended Italy’s experimental trials of the dangerous RU 486 abortion drug on Wednesday.
The decision comes two weeks after a hospital in the northern city of Turin began the initial test runs of supplying women with the drugs for abortions. Storace said he made the decision to halt the trials because reports had surfaced showing one in 20 women taking the abortion drugs were having partial abortions at home followed by excessive bleeding.
He said the health risks combined with the illegality of abortions not being performed in a hospital prompted him to shut down the experiment.
The decision follows information from the Food and Drug Administration in the United States showing 5 women have died from infections resulting form using the mifepristone abortion drug. Abortion advocates are already decrying the decision as political rather than related to women’s health concerns. They say Storace, who is aligned with the conservative National Alliance party is trying to chip away at the 1978 law that legalized abortion there. [Rome, LifeNews.com Pro-Life News Report 26Sept05]
ON THE TRAIL OF A KILLER – The family of a 21-year-old CA woman is suing the makers and distributors of RU-486.
Teaching student Hoa Thuy Tran died 29Dec03 after taking RU-486 – a medical abortion – at a Costa Mesa Planned Parenthood site. Once again, according to the lawsuit, the victim died from a sepsis infection.
Local coroner P. M. Murphy did not do an autopsy, because there was “no indication of foul play.” Murphy is the Clark County, Nevada coroner. (Miss Hoa died in Las Vegas.) “We have the death listed as a cardiac arrest with acute undetermined etiology,” said Murphy.
“The question is: Is that death actually as a result of RU-486? We don’t have anything in our records that indicate it.” Melissa May of Population Council, which distributes RU-486, claimed the drug is “safe and effective.” May said that there is no causal relationship between use of the abortion pill and the California deaths. Well, of course not. The coroner didn’t do an autopsy.
How many other RU-486 deaths are going unreported because there is “no indication of foul play”? The family of Hoa Thuy Tran is suing Danco Laboratories, makers of RU-486, Planned Parenthood, and the Population Council. By the way, the story of this tragic death was only on Page B4 Metro Section of the Los Angeles Times. This second patient death at a California Planned Parenthood affiliate occurred over three months after Pattersons death.
One wonders if Planned Parenthood had changed its procedures following Hollys death, if Tran would still be alive.
According to attorney Mark G. Crawford, who filed the lawsuit on behalf of Trans family, “The main point is that she was not given any warnings of any risk of death, of any risk of infection, of any risk of septic shock.”
So what does Planned Parenthood have to say about this second death of one of its RU-486 patients? Well, the Los Angeles Times reports that Kimberlee Ward, vice president of public affairs at Planned Parenthood, said her organization cannot comment on the suit but “we are very sorry and express our sympathy to the family for any death that has occurred.” [emphasis added, FRC,11Oct05; Wed STOPP Report, 12Oct05, Ryan Report]
FDA ISSUES WARNING ABOUT ABORTION PILL warned doctors 19July05 to be on the lookout for rare but deadly infections in women using the abortion pill RU-486, citing 2 mor
e
deaths after its use.
At least 5 U.S. women have died after taking the pill since it began selling in 2000, although FDA stressed that it could not prove the drug was to blame. But the 4 deaths caused by bloodstream sepsis all occurred in women who didn’t follow FDA-approved instructions for a pill-triggered abortion, said chief Dr. Steven Galson.
Still, the FDA issued a public health advisory warning doctors of the possible link and urging them to be on the lookout for infections in women who have used the Mifeprex abortion pill.
Such women may not have typical symptoms of sepsis, such as a fever. The action comes just 8 months after the FDA warned about 2 sepsis cases associated with Mifeprex, also called RU-486 or mifepristone. Additional sepsis cases were reported to FDA in April & June.
The drug, sold by Danco Labs, is approved to terminate pregnancy up to 49 days after the beginning of the last menstrual cycle. When followed by misoprostol, the pregnancy is terminated [aborted].
The FDA’s instructions call for women to swallow both pills, but most abortion sites instead instruct that the misoprostol tablet be inserted into the vagina. Studies have shown it can work that way, too. But the 4 sepsis deaths, all reported from CA, came after this so-called off-label use. Galson couldn’t say if the women had inserted the tablet vaginally themselves. In 2 of the infections, doctors identified the bacterium Clostridium sordelli. The abortion pill remains safe enough to stay on the market, Galson stressed. [IF all Mifeprex mortalities are being accurately reported] the rate of sepsis is about 1 in 100,000 uses of the Mifeprex system. The other U.S. death associated with Mifeprex was a case of a ruptured ectopic pregnancy in 10/2001. [AP, 7/20/2005, 6:35 a.m. CT, D.C., By LAURAN NEERGAARD; Food and Drug Administration: http://www.fda.gov/]
LAWMAKERS WANT ABORTION DRUG PULLED AFTER MORE WOMEN DIE — Maryland Rep. Bartlett said it was “disturbing” that the manufacturer of Mifeprex, Danco, “buried in a news release” information about 2 more women who have died from using the abortion pills. “Clearly labels and letters to doctors are not protecting the life and safety of young American women from this dangerous drug,” Rep. Bartlett said. Bartlett is the sponsor of HR 1079, which would remove RU 486 from the market while the FDA launches a thorough review of its safety. SC Sen. DeMint, who has sponsored a similar bill in the Senate, agreed that the legislation is necessary. Dubbed “Holly’s Law,” the measure is named after Holly Patterson, a CA teen who died in 9/2003 after using the abortion drug. She received the pills at a San Francisco area Planned Parenthood, which instructed her to use the drugs in a manner inconsistent with FDA protocol. [19July05, LifeNews.com, Livermore, CA; 22July05, D.C., http://www.lifenews.com/nat1451.html]
In a statement released Monday, Danco admitted it has received “reports of five deaths from serious bacterial infection and sepsis” since the FDA approved its application to sell the abortion pill in September 2000. Danco reports that two women died in 2003, one in early 2004, and “a recent one in mid 2005.” The company did not reveal any additional information about the recent death. Danco denies its drug is responsible for the women’s deaths. Frank Gentle, supervising coroner investigator who looked into Patterson’s death, said “septic shock, due to endomyometritis (inflammation) due to therapeutic, drug-induced abortion,” caused Patterson’s death. In other words, “the abortion caused inflammation, which caused the shock, which caused her death,” Gentle said. According to Danco, more than 500,000 women have used the mifepristone abortion drug.
RU 486 HURT OVER 600 WOMEN IN ADDITION TO DEATHS — neither the FDA nor Danco Labs disclosed that the drug caused sometimes severe health problems for more than 600 women.
“Last week’s FDA announcement on RU 486 mentioned the deaths linked to RU 486, but neglected to release information about near-fatal adverse events,” said Wendy Wright, of Concerned Women for America.
Under the Freedom of Information Act, CWA received public documents from the FDA listing over 600 adverse events cited by women using the abortion drug.
Two OB/GYNs asked by the group to assess the reports found they included 220 cases of hemorrhage that were either life-threatening or extremely serious — 71 of which required blood transfusions. In addition, 392 reports indicated women required surgery to repair damage resulting from the [chemical] abortion, including many under emergency conditions.
Wright says the FDA needs to be more forthcoming about the risks associated with the abortion drug and to make the information about both deaths and severe health problems public. She also called on the agency to pull the Mifeprex abortion drug from the market while it reviews its safety.
The information about the hundreds of health problems women faced comes a day after a Brown University researcher announced he has developed models to explain why women died after using the abortion drug.
According to professor Ralph Miech, MD, Ph.D., the abortion drug triggers a bacterial infection in a woman’s cervical canal that doesn’t normally occur. The bacteria thrive on the decaying tissue from the dying unborn child and impairs the woman’s ability to fight off the infection.
Miech’s research confirms admissions from both the FDA and Danco that women may not show signs of the infection until it’s too late. Three of the American women who died after using the RU 486 abortion pills had the C. sordellii bacteria present in their systems upon investigation. The status of the other 2 women is unknown. “The FDA allows the death toll to mount and confesses to being baffled’ by the deaths,” Wright said. “Thanks to the hard work of [Miech], we may have the answer to why RU 486 causes harm to women as well as their babies.” [DC; Ertelt, LifeNews.com 28July2005]
MIFEPREX IS MIFEPRISTONE, or RU486. Dose: 600 mg first day. Mifeprex kills the lining of uterus, which results in no oxygen or nutrients to the embryo/fetus, resulting in the death of the embryo/fetus.
Misoprostol is Cytotec, a prostaglandin used to cause contractions. Dose 400 mg 2 days after the Mifeprex. Cytotec causes contractions which squeeze the dead products out. Cytotec is also used to induce labor or ripen the cervix, which is a legitimate (though off label) use of the drug, whose approval years ago by FDA was to prevent stomach ulcers when using motrin type medications. Other uses (labor, abortion,) are “off label” but allowable. [DeCook, MD, for AAPLOG]
TOXIC SHOCK SYNDROME AFTER MEDICAL ABORTION
On July 19, 2005, the Food and Drug Administration (FDA) issued a public health advisory [Clostridium sordellii Toxic Shock Syndrome After Medical Abortion with Mifepristone and Intravaginal Misoprostol — United States and Canada, 2001-2005] regarding the deaths of 4 women in the USA after medical abortions with Mifeprex® (mifepristone, formerly RU-486; Danco Labs, New York, NY) and intravaginal misoprostol (1).
Two of these deaths occurred in 2003, one in 2004, and one in 2005. Two of these U.S. cases had clinical illness consistent with toxic shock and had evidence of endometrial infection with Clostridium sordellii, a gram-positive, toxin-forming anaerobic bacteria.
In addition, a fatal case of C. sordellii toxic shock syndrome after medical abortion with mifepristone and misoprostol was reported in 2001, in Canada (2). All three cases of C. sordellii infection were notable for lack of fever, and all had refractory hypotension, multiple effusions, hemoconcentration, and a profound leukocytosis.
C. sordellii previously has been described as a cause of pregnancy-associated toxic shock syndrome (3). Investigation by FDA, CDC, and state and local health departments into the two most recently identified U.S. deaths after medical abortion is ongoing. Empiric therapy for patients suspected of having postpartum or postabortion toxic shock syndrome should include antimicrobials with anaerobic activity against Clostridium species.
Health-care providers are encouraged to report any cases of postpartum or postabortion toxic shock syndrome to their state or local health department and to CDC at telephone 800-893-0485. Cases potentially associated with use of mifepristone or misoprostol should also be reported through the FDA MedWatch system available at http://www.fda.gov/medwatch/index.html or telephone 800-FDA-1088.
References:
1. Food and Drug Administration. FDA Public Health Advisory: sepsis and medical abortion. Rockville, Maryland: Food and Drug Administration, Center for Drug Evaluation and Research; 2005. Available at http://www.fda.gov/cder/drug/advisory/mifeprex.htm. 2. Sinave C, Le Templier G, Blouin D, Leveille F, Deland E. Toxic shock syndrome due to Clostridium sordellii: a dramatic postpartum and postabortion disease. Clin Infect Dis 2002;35:1441–3.
3. McGregor JA, Soper DE, Lovell G, Todd JK. Maternal deaths associated with Clostridium sordellii infection. Am J Obstet Gynecol 1989;161:987–95.
[MMWR Weekly 22July05 / 54(Dispatch);1]
PATHOPHYSIOLOGY OF MIFEPRISTONE-INDUCED SEPTIC SHOCK – Abstract:
OBJECTIVE: To explain the role of mifepristone in medical abortions that results in fulminant and lethal septic shock due to Clostridium sordellii.
DATA SYNTHESIS: The mechanisms of action of mifepristone were incorporated into the pathophysiology of septic shock due to C. sordellii.
Mifepristone, by blocking both progesterone and glucocorticoid receptors, interferes with the controlled release and functioning of cortisol and cytokines. Failure of physiologically controlled cortisol and cytokine responses results in an impaired innate immune system that results in disintegration of the body’s defense system necessary to prevent the endometrial spread of C. sordellii infection. The abnormal cortisol and cytokine responses due to mifepristone coupled to the release of potent exotoxins and an endotoxin from C. sordellii are the major contributors to the rapid development of lethal septic shock.
CONCLUSIONS: Theoretically, it appears that the mechanisms of mifepristone action favor the development of infection that leads to septic shock and intensifies the actions of multiple inflammatory cytokines, resulting in fulminant, lethal septic shock.
Key Words: abortion, Clostridium sordellii, mifepristone, septic shock. MEDLINE, PubMed, and Google Scholar databases were searched (1984-March 2005). Key search terms were mifepristone, RU38486, RU486, Mifeprex, medical abortion, septic shock, innate immune system, cytokines, and Clostridium sordellii.
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STUDY SELECTION AND DATA EXTRACTION: All articles identified from the data sources were evaluated and all information deemed relevant was included for the information related to the development of the understanding of the pathophysiology of mifepristone-induced septic shock due to C. sordellii.
[Dr. Miech, July 2005; Pathophysiology of Mifepristone-Induced Septic Shock Due to Clostridium sordellii, Ralph P Miech MD PhD., Assoc Prof Emeritus, Dept of Molecular Pharmacology, Physiology, Biotechnology, Brown Medical School, Brown University, 174 Meeting St., Providence, RI 02912-9107, fax 401/863-1595.
PDF of study: http://www.theannals.com/cgi/reprint/aph.1G189v1.pdf]
