Analysis of Mifepristone Adverse Event Reports

The abortion drug mifepristone (Mifeprex,TM RU-486), initially touted as a more convenient alternative to surgical abortion, has been linked to serious adverse reactions, including several deaths in otherwise healthy women. In "Analysis of Severe Adverse Events Related to the Use of Mifepristone as an Abortifacient," researchers Margaret M Gary MD and Donna J Harrison MD provide an in-depth study of mifepristone adverse event data gathered through the FDA's Adverse Event Reporting System. Their research is available now at The Annals of Pharmacotherapy Online (www.theannals.com) and will appear in the journal's February issue. This first published analysis of the FDA's mifepristone reports describes 607 adverse events reported over a 4-year period, including fatalities resulting from bleeding or septic shock. Also reviewed are numerous reports of severe bleeding, infection, unsuccessful termination of pregnancy, and fetal malformations that appeared after failed abortion attempts. Reports also detail ruptured ectopic pregnancies, a potentially fatal condition requiring emergency surgical intervention. Unusual allergic reactions were also noted, which Gary and Harrison suspect may have resulted directly from the drug's mechanism of action. Prompted by their findings, the authors call for increased research into the allergic and fatal septic reactions associated with mifepristone. They also urge that ultrasound imaging be performed before use of the drug to rule out ectopic pregnancies and propose that a fetal registry be established to track birth defects in mifepristone survivors. Finally, incomplete information in many of the adverse event reports prompts Gary and Harrison to speculate on whether the FDA's Adverse Event Reporting System adequately identifies risks and protects public health. At least 5 women in the US and Canada are known to have died from septic shock after taking mifepristone. In 2004, the labeling of mifepristone was amended to include a black box warning about bacterial infections, sepsis, and death that may occur after use. A citizen petition for withdrawal of mifepristone from the US market has been submitted to the FDA. The petition cites numerous safety concerns and FDA procedural violations that occurred during the drug's approval.

You and I both know that the coverage will be a big fat ZERO!

Danco is a mysterious company with supposedly sole distribution rights. The drug is made in Communist China.

A Rochester NY abortionist at The University of Rochester violates the intentions and directions of FDA Approval. He uses vaginal insertion and goes beyond the recommended 49 day length of usage.

The septic shock deaths seemed to be caused by by vaginal insertion method rather than by mouth.

Followups are neither regulated nor regular.

Article to kindle abortion pill fight
Report on deaths may hike pressure on FDA to curb sales
By Diedtra Henderson, Globe Staff | December 1, 2005

WASHINGTON -- An article in today's New England Journal of Medicine could increase pressure on the Food and Drug Administration to restrict the sale of abortion pills associated with four fatal infections in California.
The FDA in September 2000 approved Mifeprex -- also called RU-486 and known generically as mifepristone. It is used with a second drug, misoprostol, to induce early-stage abortions.

But as early as 1992, scientists warned mifepristone could make women vulnerable to massive bacterial infections. Some doctors have routinely defied FDA recommendations by advising women to administer misoprostol vaginally. Some researchers say that could transport bacteria near the uterus, where they can grow unchecked.

Today's article says four young, otherwise healthy women in California died from such bacterial infections soon after using RU-486 and misoprostol.

Conservative politicians and abortion foes have already been pressuring the FDA to take RU-486 off the market. The agency said it will convene a meeting to attempt to determine whether there is a connection between the abortion pill and the fatal infections.

A Canadian woman also died from the infection. The deaths, out of about 510,000 medical abortions involving RU-486, while rare, amount to a roughly 1 in 100,000 risk of developing a fatal bacterial infection. That compares with a 0.1 in 100,000 risk for women who undergo surgical abortions performed at the same stage of pregnancy, according to the Journal article.

Danco Laboratories, which manufactures Mifeprex, said the fatal infections were not caused by its drug. Nor does vaginal administration of misoprostol increase the risk of infection, said Cynthia Summers, a Danco spokeswoman.
Days after using Mifeprex and misoprostol, the women complained of abdominal pain and vomiting. Without the typical warning sign of fever, a rare bacteria -- Clostridium sordellii -- multiplied inside their bodies, pumping out toxins. Within hours of seeking medical treatment, the women were dead.

A team of medical sleuths who investigate unexplained deaths studied clues from the women's tissues -- in one case, performing an autopsy after a woman had been embalmed -- according to today's Journal.

''I think, for women, the take-home message just is that this is a now known, rare complication with this medication and they should be aware of that," Dr. Marc Fischer, a Centers for Disease Control researcher who was lead author of the article.

When the FDA approved Mifeprex, it did so with its strongest label warning. The label has since been updated to include information about other serious complications.
In the Journal article, 13 federal and state investigators described a cluster of symptoms that physicians should watch for -- including elevated heart rate, markedly elevated white blood cell counts, higher-than-normal red blood counts and eventual development of low blood pressure.
''These deaths have important implications both for the care of individual patients and for public policy," said Dr. Michael F. Greene, obstetrics director at Massachusetts General Hospital, in an editorial in today's Journal.

excerpt:
http://www.boston.com/business/healthcare/articles/2005/12/01/article_to_kindle_abortion_pill_fight?mode=PF

Coroner: Drug-induced abortion led to teen's death
Sunday, November 2, 2003

From The Associated Press
http://www.napanews.com/templates/index.cfm?template=story_full&id=74FEF248-589E-4469-9E6B-15F75E011DE2

LIVERMORE -- The Alameda County Coroner's Office has confirmed that a therapeutic drug-induced abortion led to the death of an 18-year-old Livermore woman who died Sept. 17.

According to the autopsy report released Friday, Holly Patterson died of septic shock caused by endomyometritis, an inflammation of the uterus. The report says that endomyometritis was caused by a drug-induced abortion.
Although Patterson died just days after initiating an abortion with the drug RU-486, the controversial abortion medication was not specifically mentioned in the teen's Cause of Death report.

The finding is consistent with what doctors at Valley Care Medical Center in Pleasanton told Holly's father, Monty Patterson, in the hours after her death Sept. 17.

"This confirms what we believed is the cause of Holly's death," said Helen Wilson-Patterson, in an e-mail to The Associated Press.

The 18-year-old was given the abortion pill a week earlier by a Planned Parenthood Clinic in Hayward, where she sought it without the knowledge of her father. When she fell ill Sept. 14, her boyfriend rushed her to Valley Care Medical Center, where she reportedly was told that her pain and bleeding were normal, and she was sent home with painkillers.

She returned to the hospital three days later, on Sept. 17, and died.

The teenager's death has become a cause celebre among anti-abortion groups, though her grief-stricken father has not taken a political position.

"I am not putting out a pro-choice or pro-life stand," he explained. "We need to know that drugs are safe, and if they are not safe, do something about it."

Patterson also said he and his wife feel it is their duty to inform other teenagers, young adults and parents about the "grave dangers" of the drug.
The FDA in July issued a warning to doctors to watch out for signs of sepsis or other infections and noted that normal telltale signs may not appear until it's too late.
The agency updated its strong black box warning in November after it discovered that all four California women were infected by Clostridium sordellii, a rare and deadly bacterium.
Observers suspect the infections may have occurred because Planned Parenthood abortion businesses instruct women to use the first of the two-part abortion drug vaginally instead of orally as the FDA recommends.

Printed from: http://www.lifenews.com/nat1849.html
COMPLICATIONS FROM ABORTION PILL CAUSE INDIA TO REVISE GUIDELINES NEW DELHI,
October 21, 2002
http://www.lifesite.net/ldn/2002/oct/02102103.html
(LSN.ca) - The Indian government has announced that it will revise its lax guidelines on the abortion pill RU-486. Reports of life-threatening complications arising from the use of the pill from around the country have led to the changes.

Dr J V R Prasada Rao, secretary, Department of Family Welfare told reporters that despite a prescription-only regulation, the abortion pill was being handed out over the counter in some places. Dr Ashwani Kumar, Drug Controller of India, said that caution was needed for using RU-486 as it could lead to life-threatening haemorrhage.

Ashwani hinted at the content of the upcoming guidelines noting that the drug should be used only in hospitals and nursing homes which have blood transfusion back-up support.

See the PTI coverage at:
http://www.hinduonnet.com/thehindu/holnus/02211813.htm
National
Guidelines on use of abortion pill coming
http://www.hinduonnet.com/thehindu/holnus/02211813.htm
New Delhi, Oct. 21. (PTI): In view of complications being reported owing to improper use of RU-486, an early abortion pill, from various parts of the country, the Government has decided to formulate guidelines on its use.
RU-486 (Mifepristone), an anti-progesterone drug, has been approved for use in India for termination of early pregnancy, Dr J V R Prasada Rao, secretary, Department of Family Welfare, said today at the inauguration of a national expert group meeting to formulate these guidelines.
However, despite regulation to sell the drug on prescription only, there are reports of its free availability over the counter, Rao said.
Rao said unwanted pregnancy was a major public health problem with potentially serious consequences for women's health. Despite availability of several contraceptive methods, the need for abortion continues.
Speaking on the occasion, Dr Ashwani Kumar, Drug Controller of India, said that caution was needed for using RU-486 as it could lead to life-threatening haemorrhage.
The drug should be used only in hospitals and nursing homes which have the back-up support for blood transfusion. All the clinics might not be having the required facilities to meet an emergency, he said.
"After the guidelines are formulated, these would be passed on to us and we will evolve a policy," he said.

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