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F.D.A. Strengthens Warning on the Abortion Pill
NY Times ^ | November 16, 2004 | GARDINER HARRIS

Posted on 11/15/2004 8:24:28 PM PST by neverdem

WASHINGTON, 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.

Opponents of abortion say the latest death demonstrates that mifepristone is unsafe and should be withdrawn from the market. Abortion rights advocates, on the other hand, say that it has been used by nearly 360,000 women in the United States and that bad outcomes with it are exceptionally rare.

In the case of the latest death, though, the argument does not end there. Dr. Cynthia Summers, spokeswoman for mifepristone's American maker, Danco Laboratories, said she did not believe the fatality should be attributed to the drug, since the coroner's report said the woman had instead taken methotrexate, a cancer medication that has also been used to induce abortions.

"We believe our drug is not to blame," Dr. Summers said.

Dr. Lester Crawford, acting commissioner of food and drugs, disagreed.

"Our investigation reveals that it was due to mifepristone," Dr. Crawford said. The F.D.A. would not elaborate.

Anti-abortion politics played no role in the agency's decision, Dr. Crawford said. "We received no political direction or counseling whatsoever" from the White House, he said.

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 young 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.

Ms. Patterson's father, Monty Patterson, became an outspoken critic of the pill. He said Monday that he was glad the F.D.A. had acted, adding, "Holly did not die in vain.''

Still, the agency's actions are not enough, Mr. Patterson said.

"I'm not convinced this drug is safe,'' he said, "and I still think it should be banned.''

As a result of Ms. Patterson's death, the agency had already been considering changes to mifepristone's label when, in August, officials there learned of the latest death, after Danco had forwarded a copy of the coroner's report.

Danco is required to forward any such reports to the F.D.A., and Dr. Summers said it had done so after someone sent it to the company even though another drug, not Danco's, was listed as the cause of death.

Among abortion opponents calling Monday for mifepristone's removal from the market was National Right to Life.

"I think the evidence is mounting that this drug is unsafe," said Dr. Randall O'Bannon, the group's director of education and research.

Wendy Wright, senior policy director of Concerned Women for America, a conservative women's group that has petitioned the F.D.A. to withdraw the drug, said the agency's action was insufficient.

"How many more women have to die before F.D.A. will put women's health and lives above the politics of abortion?" Ms. Wright said.

But Elizabeth Cavendish, interim president of Naral Pro-Choice America, said news of the latest death and the label change "are not monumental."

"These updates are really rather routine," Ms. Cavendish said.

Dr. Paul Blumenthal, associate professor of obstetrics and gynecology at Johns Hopkins University School of Medicine and adviser to Planned Parenthood, said taking mifepristone was safer than taking a pregnancy to full term. And even tampons can, in rare cases, cause serious bacterial infections, he said.

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

The medication 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. The risks of excessive bleeding are also being emphasized, after a woman in Europe bled to death without seeking medical help.

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.


TOPICS: Business/Economy; Culture/Society; Front Page News; Government; News/Current Events; US: District of Columbia
KEYWORDS: abortion; fda; health; labeling; labels; medicine; mifepristone; ru486

1 posted on 11/15/2004 8:24:29 PM PST by neverdem
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To: neverdem
Site Meter
2 posted on 11/15/2004 8:25:01 PM PST by KMC1
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To: neverdem

Naturally, in their zeal for abortion on demand, NOW and Planned Parenthood will NOT insist on an FDA ban of a drug linked to the deaths of women.


3 posted on 11/15/2004 8:26:32 PM PST by goldstategop (In Memory Of A Dearly Beloved Friend Who Lives On In My Heart Forever)
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To: goldstategop
A FREEPER NEEDS OUR HELP!
4 posted on 11/15/2004 8:27:24 PM PST by ConservativeMan55 (http://www.osurepublicans.com)
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To: neverdem

The abortion industry is far more interested in profits than it will ever be in the health of women (and certainly never babies).


5 posted on 11/15/2004 8:28:43 PM PST by Aussie Dasher (Stop Hillary - PEGGY NOONAN '08)
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To: neverdem

Isn't death the intended consequence?

Ironic, that.


6 posted on 11/15/2004 8:28:52 PM PST by Uncle Miltie (Democrat Obstructionists will be Daschled!)
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To: ConservativeMan55

Now goldstategop has been pinged twice to help. 8^)


7 posted on 11/15/2004 8:30:42 PM PST by neverdem (Xin loi min oi)
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To: goldstategop

Abortion has become a religion, to the feminazis.


8 posted on 11/15/2004 8:30:43 PM PST by Paul Atreides
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To: neverdem

Whoo Hoo!


9 posted on 11/15/2004 8:32:13 PM PST by ConservativeMan55 (http://www.osurepublicans.com)
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To: fourdeuce82d; El Gato; JudyB1938; Ernest_at_the_Beach; Robert A. Cook, PE; lepton; LadyDoc; jb6; ...

FReepmail me if you want on or off my health and science ping list.


10 posted on 11/15/2004 8:32:26 PM PST by neverdem (Xin loi min oi)
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To: neverdem

If this were not an abortion drug, it would be pulled immediately. (Vioxx was pulled with less evidence)


11 posted on 11/15/2004 8:32:42 PM PST by Angry Enough
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To: neverdem

"WARNING: Research indicates that this pill murders babies."


12 posted on 11/15/2004 8:33:07 PM PST by smonk
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To: neverdem

If this was a drug which helped women become pregnant you can bet it would have been yanked off the market in 2001 when the first death occured. It certainly is ironic that a drug manufactured to kill a fetus is being yanked because it can end of killing the mother.


13 posted on 11/15/2004 8:33:24 PM PST by taxesareforever
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To: neverdem
How about the following warning:

Users of this product are likely to suffer eternal hellfire. Symptoms include extreme agony and misery. All side effects are for eternity.

14 posted on 11/15/2004 8:34:56 PM PST by Grey Ghost II
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bad outcomes with it are exceptionally rare.

Tell that to the babies.

15 posted on 11/15/2004 8:36:42 PM PST by A.A. Cunningham
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To: taxesareforever

It's not being yanked. "F.D.A. Strengthens Warning on the Abortion Pill"


16 posted on 11/15/2004 8:37:08 PM PST by neverdem (Xin loi min oi)
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To: neverdem

I feel ashamed at my lack of sympathy for these women.


17 posted on 11/15/2004 8:37:10 PM PST by Safrguns (<div align="right"><img src="http://tinypic.com/lzjnn"></div>)
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To: neverdem
In Great Britain, a number of years ago, a study was being conducted on a male birth control pill. Word is a few men had some unwanted problems. I can't remember exactly what the problems were but no one died, and they called the whole study off. They also discontinued work on that male birth control pill. I don't think that anyone has attempted another study like it. No man died during that study, I might add. Did I add that no man died? That's right, no man died.
18 posted on 11/15/2004 8:41:15 PM PST by Slyfox
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To: neverdem
after a woman in Europe bled to death without seeking medical help.

This is the key. The drug itself doesn't cause any problems that a natural miscarriage doesn't cause. It's when women don't seek medical help promptly when they have symptoms of serious complications, that the tragedies happen -- both with RU-486 and with natural miscarriages.

Remember the college girl who bled to death in a dorm bathroom after miscarrying a couple of years ago? She was in big trouble, and a couple of other students in the dorm had asked her if she was okay when they noticed her holed up in a toilet stall, but she turned them away saying she didn't need help.

19 posted on 11/15/2004 8:42:29 PM PST by GovernmentShrinker
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To: Safrguns

Oh darn it. Women managed to figure out how to make fetuses, then die trying to kill them. Hate that.


20 posted on 11/15/2004 8:46:08 PM PST by GnuHere
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To: neverdem

Part of the ongoing Clinton legacy, he fast-tracked the abortion pill with an executive order by-passing normal FDA required testing for this foreign drug.


21 posted on 11/15/2004 10:43:41 PM PST by Mogollon
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To: neverdem

It's not being yanked. "F.D.A. Strengthens Warning on the Abortion Pill"

Sorry about my misperception. I should have known they wouldn't yank it since it still ends life of a fetus. It certainly would have been surprising if they had yanked it even after confirmed deaths of mothers since 2001. The FDA is playing to the band called Planned Parenthood.


22 posted on 11/15/2004 11:49:48 PM PST by taxesareforever
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