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Life Threatening Risks Force Further FDA Precautions for RU-486

Riprorin

Banned
Life Threatening Risks Force Further FDA Precautions for RU-486

Tuesday November 16, 12:39 pm ET

'The Clinton Legacy Has Left Us With Women With Sepsis, Infection and Death,' Dr. Pia de Solenni, FRC Director of Life and Women's Issues

WASHINGTON, Nov. 16 /PRNewswire/ -- Yesterday the Food and Drug Administration (FDA) announced revised labeling for the drug Mifeprex, most commonly known as RU-486, which was approved in 2000 under the Clinton administration.

The FDA and Danco Laboratories, the drug's manufacturer, have received reports of serious bacterial infection, sepsis, bleeding, ectopic pregnancies that have ruptured, and death. RU-486 is an abortifacient requiring three doctor visits and two drugs, which kill and expel the unborn child up to 49 days after conception.

"The FDA must place women's health first. For the last four years, American women have been denied the truth about this drug: that it could seriously harm and even kill them. Instead, their lives were placed in jeopardy, because the approval process for RU-486 was short-circuited due to political motivations," says Dr. Pia de Solenni, Director of Life and Women's Issues with Family Research Council.

Even though pregnancy is not a disease, under the Clinton Administration RU-486 was put on an accelerated approval process intended for experimental drugs in the treatment of life-threatening illnesses. RU-486 was known to have serious side effects such as hemorrhaging and uterine rupture. Both were known at the time the drug was approved.

"This is the result of the Clinton legacy," says de Solenni, "women are dying from a drug that has evaded rigorous testing."

FRC does not condone the approval or use of RU-486. "The protection of innocent human life as well as the safety and health of American women must be first and foremost in the FDA's approval process," continues de Solenni.

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Source: Family Research Council

Link
 
Why is there such a political spin on an article about a drug the FDA approved that causes issues? Isn't the FDA in existence to prevent these scenarios? So much finger pointing.
 
Originally posted by: skace
Why is there such a political spin on an article about a drug the FDA approved that causes issues? Isn't the FDA in existence to prevent these scenarios? So much finger pointing.

There were red flags 4 years ago:

RU-486 FDA Approval?Senator Tim Hutchinson (R-AR) 9/28/2000

Senator Tim Hutchinson issued the following statement today, criticizing the Food and Drug Administration's approval of the RU-486 abortion drug:

?I strongly condemn the FDA's approval of the RU-486 abortion drug. Today's approval is further indication that the White House has done everything it can to make sure this abortion drug is pushed through before the President leaves office. This Administration has completely politicized the drug approval process, proving they are more concerned with rewarding the abortion lobby than in the safety of the drugs that are approved.

It is highly offensive that the Clinton Administration accelerated the drug approval process for RU-486, even faster than the average time for 'fast-tracked' drugs. Fast-track timetables are supposed to be reserved for drugs that will combat life-threatening diseases like cancer or AIDS. In this case, the Administration rushed a drug through that will take lives instead of saving them.

This process has been tainted by politics in an unprecedented manner. The fact is, the median total review time for new drug applications is 14.8 months. FDA review time for RU-486 was a mere six months. Today, I am calling for the Health, Education, Labor and Pensions Committee to hold hearings about the FDA's questionable approval process in regard to RU-486.

The Clinton-Gore Administration, which claimed it wanted to make abortion 'rare,' has now approved the marketing of RU-486, an abortion drug, as a means of contraception. Unfortunately, this abortion pill will kill increasing numbers of unborn babies and will pose new dangers to women.?

RU-486 has a low success rate unless it is used in combination with a powerful prostaglandin drug. This multi-step, multi-week RU-486 process poses serious health risks to women. Even under the controlled conditions of clinical trials, the RU-486 process puts one out of every 100 users in the hospital. Two percent of women have had such a severely negative reaction to RU-486 that they've needed surgery.

A report in the September 5th edition of the Wall Street Journal, based in part on leaked documents from Danco Laboratories, suggests that Danco may have arranged with the People's Republic of China to produce the RU-486 pills that will be sold in the U.S. In hearings earlier this year, the House Commerce Committee's Oversight Subcommittee criticized the FDA for failing to adequately protect the public from dangerously tainted imported drugs. China was cited as a major supplier of tainted drugs.

?If this report is true, it raises a number of additional serious concerns that Congress needs to investigate,? said Hutchinson.

Link
 

Letter from Monty and Helen Patterson
By Monty and Helen Patterson
CNSNews.com Information Services
November 07, 2003

(Editor's Note: The following letter was released Thursday by Monty and Helen Patterson, whose daughter's death was linked to abortion drug RU-486.)

November 6, 2003

Dear Sir or Madam:

The Alameda County Coroner's report has validated what we already believed to be true. Holly has died from an RU-486 chemical induced abortion. There are no quick fixes for a pregnancy or magical pills that will make it go away. Our family, friends and community are all deeply saddened and forever marred by Holly's tragic and preventable death.

Holly lived as an adult by law for only 19 days, yet she became pregnant when she was just 17 years old. We now know that she learned about her pregnancy in the second week of August and was so distraught over her unplanned pregnancy that she sought help for depression from her family doctor on September 10, 2003 - the very day that she began the drug induced abortion process.

Holly was a strong, healthy, intelligent and ambitious teenager who fell victim of a process that wholly failed her, beginning with the 24-year-old man who had unprotected sex with her, impregnated her, and then proceeded to facilitate the secrecy that surrounded her pregnancy and abortion. Under this conspiracy of silence, Holly suffered and depended on the safety of the FDA approved pill administered by Planned Parenthood and emergency room treatment by Valley Care Medical Center where she received pain killers for severe cramping and was sent home. On Saturday and Sunday, Holly cried and complained of severe cramping and constipation, and even allowed us to comfort her but could not tell us what she was really going through. On September 17, 2003, she succumbed to septic shock and died while many members of our family waited anxiously, yet expectantly in the Critical Care Unit for her to recover until we were forced behind the curtain when it was clear that she was dying.

And in those last moments of her life feeling utter disbelief and desperation we formed a circle just beyond the curtain and prayed aloud, cried and screamed, "We love you, Holly" hoping beyond hope that those words would ring out and save her life. And the other members of our family who drove and flew from all over the country to be by her side did not make it in time to say, "I love you" just one last time. Holly was not alone, unloved, unprotected or unsupported; she had a large family who willingly supported her throughout her short life and tragic death.

In the weeks since we buried Holly's body we are now able to recall and share the memories of our daughter's brilliant blue eyes, engaging smile, laughter, unwavering determination and sheer gentle beauty that invoked our natural instinct to protect and love her, but we will never be able to forget those last moments of her life when she was too weak to talk and could barely squeeze our hands in acknowledgement of our words of encouragement. "We love you, Holly", "Just hang in there, the whole family is coming," "You fight this Holly, you can do it."

Because Holly has died this way, we have educated ourselves about the grave dangers of this drug, become conscious of the current lack of parental notification/consent laws in California and now recognize the critical need for accurate, impartial sources of information and resources for parents, teenagers and young women who want to learn about the real dangers and risks of unplanned pregnancy and abortion and the dire need for a national movement to encourage prevention and open dialogue in the home about unplanned pregnancy and abortion.

We will actively support "Holly's Law" in Congress by Reps. DeMint, Bartlett and Senator Brownback to suspend and review the abortion drug RU-486, the Tell-A-Parent (TAP) bill, which requires parental notification laws in California and a campaign to encourage prevention and open dialogue about unplanned pregnancy and abortion in the home.

As parents, we cannot allow our beautiful Holly's horrible death to be in vain. RU-486 has caused serious injury and has been implicated in the deaths of other young women. Now it has killed our daughter. We have learned that the initial trials were rushed and the drug was lumped in and approved with drugs designed for life threatening illnesses such as cancer and AIDS. Pregnancy is a natural process that a woman's body is designed to support and has never been classified as a life threatening illness. We need help to develop a website and provide a place for teenagers and women to report their stories and testimonials of their experience on the serious and adverse affects using RU-486.

The FDA has failed to carry out its mission of ensuring RU-486 is a safe and effective abortion drug regimen. According to the FDA, it is "responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation." Holly has already paid the ultimate price.

The RU-486 abortion drug should not be either a Pro Life or Pro Choice issue. The most primary concern here must be the health and welfare of our children and young women. Hopefully, all parents can learn from Holly's horrible death and our loss. According to Danco Laboratories, the abortion drug's distributor, the RU-486 regimen fails to work 7-8 percent of the time. Over a year ago the FDA received 400 reports of adverse reactions to the drug including several deaths.Holly is yet another victim who was subject to an unacceptable risk to a drug that has a significant failure rate. And we demand that FDA Commissioner Mark McClellan and Health and Human Services Secretary, Tommy Thompson take RU-486 off the market immediately pending an extensive investigation by the Comptroller General of the United States before more parents suffer and women die.

We respectfully request the name of the bill that is to be presented to the House of Representatives, an Act cited as the "[RU-486 Approval and Review Act of 2003]" to be known as "Holly's Law." We actively support a bill that halts the use of the drug that took Holly's young life.

We demand an investigation by the FDA and the California State Health Department as to why abortion clinics like Planned Parenthood are not following FDA approved regulations to administer the drug. We question the purity of the drugs they administer, especially when they are made in foreign countries, such as China.

In addition to the dangers of this drug and its administration, we believe that health care providers such as Valley Medical Care Center don't appear to be fully prepared to evaluate and treat patients with RU-486 complications in emergency situations. Holly was in the hospital twice and died within 20 minutes before her follow up appointment with Planned Parenthood.

FDA Commissioner Mark McClellan and Health and Human Services Secretary, Tommy Thompson should now have enough evidence to pull this drug from the market. How many more teenagers and young women will have to pay the price with their health or with their life, before the FDA decides to act?

Currently in California, teenage girls under the age of 18 can't get their ears pierced or go on a school trip, but they can have a medical or surgical abortion without parental knowledge or consent. This prevents parents from being able to talk to their children about a pregnancy that would allow them to keep a baby or to be able to follow the abortion process.

The first line of defense for a child is a parent. Kids wouldn't be walking into clinics under a veil of secrecy if parents were notified first hand where they could talk to their children about abortion risks. We have now learned that Holly first sought a pregnancy test in the months leading up to her pregnancy while she was still 17 years old. We know now that a parental notification law would have brought Holly's activity to our attention and her needless death could have been prevented if we had been aware and intervened.

We actively support the Tell-A-Parent (TAP) ballot initiative sponsored by Life on The Ballot www.LifeontheBallot.org . With enough petitions, this initiative will be on the 2004 ballot and requires parental notification 48 hours prior to an abortion in California. As parents, we are concerned about the health and welfare of all daughters; we are "Pro Holly" and look to our California Senators Barbara Boxer and Dianne Feinstein to support this initiative for the safety and protection of all young women in California.

Finally, we have suffered greatly with the realization that it's not enough to avoid the issue or talk to our children about why we don't want them to be involved in an unplanned pregnancy or abortion, but as parents, we must also talk about the tragic realities of unwanted pregnancy and abortion and reassure both, our daughters and sons that while we don't want this to happen, we will support them. We must focus on prevention and they must be told that they are not alone in this or any other unfortunate circumstance, regardless of the outcome.

We feel very strongly that this country needs a national campaign to promote open and frank discussions in the home about unplanned pregnancy and the options that are available to our daughters who find themselves in this unfortunate predicament. We are eager to support such a campaign designed to bring about awareness, encourage parental involvement, and provide accurate information to minors, women, and parents about abstinence, birth control, unplanned pregnancy, abortion, parenting, and adoption options.

While parents would prefer that their daughters abstain from sex and many do, we must deal with the reality that many don't. In addition to unplanned pregnancy, girls can contract HIV and other STIs. As parents we need to prevent unplanned pregnancy instead of relying upon abortion clinics and agencies to educate our children and provide them with inaccurate information. No parent wants to see his or her teenage or college age daughter in the unfortunate situation that Holly was faced with.

We have lost our daughter, Holly, but we can still help to prevent this terrible tragedy from happening in other families. Holly's drive and determination to accomplish her goals gives us strength to pursue these critical issues in her name. Holly's memory and light will live on in our hearts, family, friends and our work. We will actively support the bill to suspend and review "Holly's Law" in Congress by Reps. DeMint and Bartlett and Senator Brownback to suspend and review the abortion drug RU-486, the Tell-A- Parent (TAP) bill, which requires parental notification laws in California and a campaign to encourage prevention and open dialogue about unplanned pregnancy and abortion in the home. Please contact us with any questions or requests for support of these very important issues.

Sincerely,
Mr. and Mrs. Monty and Helen Patterson
 
Originally posted by: Fausto
Originally posted by: AntiEverything
Originally posted by: conjur
Originally posted by: conjur
How about from a non-biased source or, better yet, Sir Copy/Paste, in your own words
WTF, you're the copy/paste king. 😕
No, he's the copy/paste Queen.....the skirt and tiara are a dead giveaway. 😛
Yeah, but the skirt shows off that Fausto-approved thong when I bend over. 😉
 
By the way Rip. There have been something like 360,000 instances of RU-486 being used in the US since it was legalized with 676 events of "adverse reactions" ranging from nausea to ectopic pregnancies with three deaths.

There were 525 pregnancy-related deaths in 1999 alone (CDC data). If my math is correct, you are 14.4 times more likely to die from carrying a child to term than to use RU-486. Sounds like the FDA should outlaw childbirth, no?
 
Originally posted by: conjur
Originally posted by: Fausto
Originally posted by: AntiEverything
Originally posted by: conjur
Originally posted by: conjur
How about from a non-biased source or, better yet, Sir Copy/Paste, in your own words
WTF, you're the copy/paste king. 😕
No, he's the copy/paste Queen.....the skirt and tiara are a dead giveaway. 😛
Yeah, but the skirt shows off that Fausto-approved thong when I bend over. 😉
The red sequins are hard to miss. 😀
 
ASHINGTON, Nov. 15 - The death of a California woman in January after she took an abortion pill prompted federal drug regulators on Monday to strengthen the warning label on the drug, RU-486, also known as mifepristone.

The death was the third in the United States that the Food and Drug Administration has linked to the pill since its approval in 2000.

The warnings, though largely present on the old labeling, will now be given added prominence, with physicians urged to redouble efforts at watching their patients carefully for signs of systemic bacterial infection, excessive vaginal bleeding and ectopic, or tubal, pregnancies.

...

The California woman died after a bacterial infection in her uterus had spread to her blood, leading to sepsis, or blood poisoning, Dr. Crawford said.

Neither he nor Dr. Summers would disclose any further information about the case, but the latest death is similar to that of Holly Patterson, a woman from the San Francisco area, who died of sepsis after taking mifepristone on Sept. 17, 2003, less than a month after her 18th birthday.

...

Dr. Paul Blumenthal, associate professor of obstetrics and gynecology at Johns Hopkins University School of Medicine and an adviser to Planned Parenthood, said taking mifepristone was safer than taking a pregnancy to full term.

Mifepristone is sold through physicians, who dispense the drugs directly to patients. Physicians are required to give patients a medication guide, which lists risks and tells them what to expect.

The guide will now be changed to instruct patients to call a health care provider right away if they have a fever, abdominal pain or heavy bleeding. It will also tell patients to take the guide with them if they go to a hospital emergency room.


Changes on the drug's physician prescribing label will say that while no causal relationship between mifepristone and bacterial infections or ectopic pregnancies has been established, physicians should be aware of the risks.

Danco will send letters highlighting the label changes to all its physician customers as well as to emergency room doctors around the country. The company sent letters in 2002 warning of the risks of infection.

The first woman in the United States whose death was tied to mifepristone suffered a ruptured ectopic pregnancy in September 2001. The F.D.A. has received 676 reports of problems with the drug, including 17 ectopic pregnancies, 72 cases of blood loss so severe that they required transfusions and 7 cases of serious infections, the agency reported.

Text

Sounds like it was the fault of the doctor prescribing the drug and the patient taking it, not following the warning signs and dealing with it in time.
 
A 92-page "Citizen Petition" filed with the Food and Drug Administration is asking the FDA to rescind its approval of RU486, the French abortion pill, because of safety concerns and procedural violations in the drug approval process.

The petition, formally filed on August 20, details numerous ways in which the Clinton-Gore FDA bent or broke its own rules to get the drug on the market just prior to the 2000 election. Now, nearly two years later, the release of government documents has given petitioners and the public at large the opportunity to see just how many times and ways the agency cut corners to satisfy a political constituency and put women's lives and health at risk.

The petition was filed by the American Association of Pro-Life Obstetricians and Gynecologists, the Christian Medical Association, and Concerned Women for America.

Excerpt
 
Birth has been found to be the #1 cause of deaths. Everyone who's lived through a birth has eventually died.

Perhaps we should outlaw births.
 
Originally posted by: Fausto
By the way Rip. There have been something like 360,000 instances of RU-486 being used in the US since it was legalized with 676 events of "adverse reactions" ranging from nausea to ectopic pregnancies with three deaths.

There were 525 pregnancy-related deaths in 1999 alone (CDC data). If my math is correct, you are 14.4 times more likely to die from carrying a child to term than to use RU-486. Sounds like the FDA should outlaw childbirth, no?

If it were any other drug, three deaths would have the liberals around here foaming at the mouth. They'd be discussing advertising budgets of drug companies, CEO salaries/benefits, corporate America, Bush, neocons, etc.

Where are the cries of "One death is too many! Down with drug companies!"

Yep, that's what I thought. Hypocrites.
 
In 1997, 225 children ages 14 and under died in bicycle-related crashes. Motor vehicles were involved in more than 200 of these deaths.

Outlaw bikes!!111one!!1!!!
 
Originally posted by: Fausto
In 1997, 225 children ages 14 and under died in bicycle-related crashes. Motor vehicles were involved in more than 200 of these deaths.

Outlaw bikes!!111one!!1!!!
From March 2003 - November 2004 1,194 Americans have been killed while fighting a war.

Outlaw war!!!11111!111!1
 
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