Two More Women Die After Using the RU-486

[BlueStorm]

I don't know what to think of this:

WASHINGTON - Two more women have died after using the abortion pill RU-486, federal health regulators said Friday, in warning doctors to watch for a rare but deadly infection implicated in earlier deaths.

In a cluster of four cases in California, the women died from an infection of the bloodstream, or sepsis. Those women did not follow FDA-approved instructions for the pill-triggered abortion, which requires swallowing three tablets of one drug, followed by two of another two days later

Instead of swallowing the final two tablets, the second course of pills was inserted vaginally in the four women, a so-called "off-label" use of the drug that studies show works and is widely recommended by abortion clinics but does not have federal approval.

RU-486 is also called Mifeprex or mifepristone. It is sold by Danco Laboratories and is approved to terminate pregnancy up to 49 days after the beginning of the last menstrual cycle. It blocks a hormone required to sustain a pregnancy. When followed two days later by another medicine, misoprostol, to induce contractions, the pregnancy is terminated.

http://www.comcast.net/news/health/index.jsp?cat=HEALTHWELLNESS&fn=/2006/03/17/347883.html&cvqh=itn_abortionpill

[gollygee]

1. How many women died of childbirth or pregnancy complications

during the same time period

[ncrainbowgrrl]

5. Or in a car crash during the same time period?

(Or from suicide- 'cause they felt like had no other option since they couldn't access a clinic/doctor who would provide safe care?)

[papau]

33. Viagra - As of September 2001, 640 deaths were reported worldwide

I agree with you - more info:

http://www.globalchange.com/viagranews2.htm

About 16 million men worldwide have taken Viagra. As of September 2001, 640 deaths were reported worldwide - but how many were actually caused by Viagra?

Viagra may cause a rare form of blindness - risk small with very few cases among 23 million users - first reports in 2005. Possible risk of blindness from non-arteritic ischaemic optic neuropathy. This is a rare condition in which blood supply is reduced to the optic nerve causing permanent nerve damage, and research workers at the University of Minnesota believe they have detected a cluster of cases of blindness from this cause in men who have taken Viagra. The US Food and Drug Administration has also identified 50 men with blindness who have taken Viagra, but who also had diabetes and heart disease. However these problems with blindness need to be seen in the context of 23 million users, most of which have experienced significant benefit to their sex lives, and the fact that blindness is a known risk in those with both diabetes and cardiovascular disease.


Viagra may be causing a small number of deaths in men with heart disease by causing platelets in the blood to stick together - clumping of platelets is important in causing heart attack and stroke. Viagra increases a compound in cells called cyclic guanosine monophosphate, or cGMP. Majority of deaths associated with the 50 mg Viagra dose. Viagra deaths seem to be due to cardiovascular causes, 66% within 4-5 hours of taking Viagra in men less than 65 years of age, and who had no reported cardiac risk factors - Viagra study by Dr. Xiaoping Du of the University of Illinois at Chicago - Cell Journal January 2003

[Nederland]

8. The difference is

These women died from doing something they were told to do by a clinic. I'm sorry, but clinics should not be recommending procedures that haven't been throughly studied, tested and approved.

[SPKrazy]

12. They Followed Off Label Use Directions

If they were informed of the risks and benefits, gave informed consent, then it is a sad situation, but there are risks with lots of things.

I don't mean to sound callous, because I'm really not. I would like to know if the clinic doctor explained the risks to the patient of doing the off label use of the med.

[Nederland]

24. Off Label Use Directions?

Isn't that an oxymoron?

[SPKrazy]

35. Not At All

Where do you get your directions for prescription drugs?

Your Physician gives them to you.

How often are off label uses used?


A lot!

Don't believe me, do some research.

[Nederland]

36. I did some research

...and it merely confirms what I already thought: using a drug for an off label use is a very bad idea.

http://www.realcities.com/mld/krwashington/news/special_packages/riskyrx/7146578.htm

http://www.findarticles.com/p/articles/mi_m3225/is_11_71/ai_n14700208

http://health.dailynewscentral.com/content/view/0001964/61/

http://www.forbes.com/2006/03/03/glaxosmithkline-advair-0303markets16.html

http://www.thedoctorwillseeyounow.com/articles/bioethics/offlabel_11/


Perhaps you should have done a little more research before spouting off about how there is nothing wrong with doctors killing their patients by prescribing drugs for uses other than intended.

[SPKrazy]

37. Did I EVER Say It Was Fucking Okay For Off Label Use?

but it happens All the time

take a chill pill

geez

[Nederland]

38. Yes you did

At least, it's hard for a reasonable person to conclude otherwise after this exchange:

Me (post 8): clinics should not be recommending procedures that haven't been thoroughly studied, tested and approved.

You (post 12): They Followed Off Label Use Directions. If they were informed of the risks and benefits, gave informed consent, then it is a sad situation, but there are risks with lots of things.


Now perhaps your post #12 was meant to express agreement me. If so, I'm glad we cleared things up and I understand your position on the issue. However, in the future I think I'd work on being a little more clear and more careful about how you choose your words. Cheers.

[SPKrazy]

41. Selective use of my words to try to make your point is childish!

Here's what post 12 said:

If they were informed of the risks and benefits, gave informed consent, then it is a sad situation, but there are risks with lots of things.

"I don't mean to sound callous, because I'm really not. I would like to know if the clinic doctor explained the risks to the patient of doing the off label use of the med."
-----------------------
Notice the part you left out!

Now, I stand by the whole post. I don't condone doctors using off label uses for drugs unless there is solid evidence that it is helpful.

apparently as the article says, the majority of national abortion clinics recommended this variation of the FDA approved use, (making it "off label")

there must have been some good evidence somewhere to justify this use.

Now I think I'm fucking clear enough my friend.

got it?

[Nederland]

46. My my

We are filled with a great deal of anger tonight, aren't we?

Clearly its time for me to shut up, because this is accomplishing nothing.

Have nice night. Cheers.

[SPKrazy]

47. Not Filled With Anger

Just tired of someone nitpicking my posts and taking selective portions of a post to try to prove their point (which is not proven by the way)

I had a great night!

Slept like a baby.

[pitohui]

50. if you didn't you should have

it is perfectly okay to go off-label on advice of your physician

"on label" is a financial and political description of a drug or technique, many "off label" uses are safe and superior to anything available "on label"

ask your doctor

one million pairs of eyes had LAZIK to correct near-sightedness "off label" before it was approved for anything but removal of cataracts, perhaps the most famous example of a super low risk procedure that it would have been stupid and a waste of your life energy to wait years -- or a decade -- for fda to finally slip the approval label on it

if you don't trust your doctor to prescribe drugs or techniques, strongly suggest you get a new doctor that you do feel is competent

if you are confined to only "on label" use of drugs, heaven help you when you have anything but the most "typical" or mundane ailment in need of treatment

me, for abortion, i prefer good ol vacuum aspiration frankly but we don't know the whole story, some women apparently would rather take a pill -- and the risk of death is still substantially less than the risk of carrying a child to term

[SPKrazy]

43. Did you know that lots of drugs are given for "off label" reasons?

It is common practice to do it.

So it's a hard argument to make that it is always wrong, or always dangerous.

There are risks to everything.

If the benefits outweigh the risks, and the patient understands the risks clearly, then off label uses might be chosen.

As for the two women in the story, there is no clear reason that is given for their deaths, it is all at this point correlation with their use of the drug.

It is probably the reason for their deaths. My guess (and hope ) is that the prescriber outlined the risks and benefits of the off label use of the abortion drug RU-485, and the patients understood those risks. Otherwise, it is clear malpractice.

One thing that happens all too often in prescribing or doing any kind of medical procedure (like surgery) is that the informed consent forms are given to the patient by someone other than the doctor, or there aren't any informed consent forms at all.

Then you have to wonder, did the prescribing physician actually make the patient aware of the risks? If not then they committed malpractice.

If so, then they had damned well better have it documented that they did.

If the nurse came in and gave them the prescription and said these are the instructions, and there was no discussion of risk, then these women were completely mislead.

[pitohui]

49. you need to research further

many drugs are prescribed for "off label" use more often than they are prescribed for "on label" use, once the fda has given approval for one use there is little incentive to spend hundreds of millions of additional dollars getting other safe ways of using a drug on the list

i would bet most drugs you've used personally in your life, you were using off label once you leave birth control pills and pain meds off the list

do you truly wish all drugs to become out of reach financially for all but the super-rich, then insist that drugs only be used "on label"

[Warpy]

21. The clinic is partially to blame, but the drug itself is not

or didn't you bother to read the part that said "Those women did not follow FDA-approved instructions for the pill-triggered abortion, which requires swallowing three tablets of one drug, followed by two of another two days later"

However, there is a sex related drug that has been known to cause hundreds of deaths when taken according to package labels and in the absence of any preexisting condition: VIAGRA.

Pregnancy and childbirth are dangerous. Undoubtedly, RU-486 has saved more live than the 7 deaths in 6 years improper use has caused.

Impotence never killed anybody, though, so why is a drug that has caused hundreds of death still on the market to treat it? Where is the hysteria over THOSE deaths?

[Nederland]

23. No, I read that part

The part that YOU didn't read is the part where I said that RU-486 was a dangerous drug that should be banned.

You didn't read that part because I didn't write it and don't believe it.

So please, stop assuming things. Thanks.

[BurgherHoldtheLies]

2. Those women did not follow FDA-approved instructions

One could die from Tylenol if they didn't follow the instructions too.

[SPKrazy]

14. One Could Die From Tylenol Even If They Did Follow Instructions

They did follow the instructions of the clinic, and by actual, or by default, the doctor.

Legally, only a doctor or a health care practitioner with prescribing privileges can obtain informed consent for a medication they prescribe.

Off label uses of meds happens all the time.

Pharma reps will often even mention off label uses, and say, of course the FDA hasn't approved this, but.....

Journals give physicians off label uses of meds.

Once a med is FDA approved, it is going to be used in off label ways if there is reason to believe, studies, etc, that an off label use is warranted, or useful.

[Vincardog]

3. How many people die after getting up in the morning?

How about this for a headline?
2 people die after having breakfast?
2 people die after being born?
2 people die after backing the radical right wing nutz agenda.

[Nederland]

10. far more than have died in Iraq this morning

...but that doesn't make Iraq a good idea either.

You argument clearly doesn't hold water.

[Vincardog]

15. Nor has the FDA confirmed the cause of the latest two deaths.

What argument doesn't hold water?

[Nederland]

26. Your argument

...that this doesn't matter because people "die all the time".

Your new argument, the that FDA hasn't confirmed the cause of death yet, is far more persuasive.

[Vincardog]

42. The FDA not confirming was in the article. I never said "die all the time"

I said the headline was just as meaningful as saying...

2 Die after doing every day normal things there does not have to be any correlation. I think thing this whole story is a load of Right Wing BS

[LiberalEconomist]

4. A more truthful headline would read something like this:

Controversial "off-label" administration of drug leads to the death of two women.

[SPKrazy]

17. Can you prove it was "controversial"?

the article says it was an off label use that studies had shown to be effective and was recommended by a majority of nations abortion clinics.

that's not controversial.

[cigsandcoffee]

44. It's controversial now.

[TAPat]

6. I can't find any links right off the bat but

this same story was out about a year ago and I believe it was "debunked".

[liberalnurse]

7. Now you have some excellent feedback....

Plus, people die every minute from non-compliance of their medication...Gheeze, look at the diabetics for a fine example.

Now, put that into perspective. Look outside the box.

[Gelliebeans]

13. exactly

this smells like fish wrap to me. I will place this right up there with the breast cancer/abortion connection.

[Pharaoh]

9. something is fishy here

this was a very safe drug..............

I smell right wing wackos behind this!!!

[Karenina]

11. Tandem team.

[JetCityLiberal]

27. Bigtime

and obvious.

[Name removed]

16. Deleted sub-thread

Sub-thread removed by moderator. Click here to review the message board rules.

[porphyrian]

18. So the drug didn't kill them, not following the directions did.

People die from taking too much acetaminaphen against the listed directions as well. This is a people error, not a pharmaceutical one (this time, anyway).

We should be seeing far more deaths related to unregulated newly-illegal abortions in some states soon.

[SPKrazy]

19. But They DID Follow The Directions Of The Clinic

for the off label use, that the article says had shown to be effective and was recommended by the majority of abortion clinics in the country.

[progressivebydesign]

40. Unfortunately, it can case fatalities.

Bad call for abortion clinics to call for that. WE're going to lose that pill if this continues. Maybe there's a reason why it's not approved for use that way.

[SPKrazy]

45. Well It Isn't Approved For Use That Way

because the company that made it didn't trial it that way, so the FDA didn't consider that method of use.

It is clear that this off label use has caused some deaths. I wonder what actual percentage that is of all users of this drug using this protocol?

I'm not saying they should continue, it is just a curious question.

The FDA is not the be all end all of drug prescribing. Lots of off label uses are discovered after a drug goes on the market and is approved by the FDA. Clinical trials continue with other ways of prescribing, or other uses.

Take for instance the many uses of some of the antidepressants. Many of them were only approved for depression initially. Now they have been used to treat depression, anxiety, PTSD, and others and have been approved by the FDA for those reasons. But initially they were off label uses for those drugs.

So off label use isn't always a bad thing. But people die from medicine, and that is a fact that no one likes to think about. The Viagra deaths mentioned above in the thread are good examples of how deaths and safety of drugs vs. politics and money and power are in competition

[Neil Lisst]

20. Consider the source

I don't know where these stories will lead.

Are they even true?

Who is behind the stories getting out and what is their angle?

I reserve judgment until I know enough to (1) trust the information, and (2) evaluate the causal link, if any, between the drug and the harm that followed.

[phylny]

22. There's a whole huge thread regarding this in Latest Breaking News:

http://www.democraticunderground.com/discuss/duboard.php?az=show_mesg&forum=102&topic_id=2173512&mesg_id=2173512

[annarbor]

25. I was just going to say...

that there's another thread on this very same topic on LBN. What the hell is going on today?
I have to say, I feel very nervous posting these days because of my low post count.

It's starting to get a little creepy around here.

Ann Arbor

(As in Michigan!)

[BlueStorm]

28. I wasn't posting to start things up..

I believe that RU-486 is safe. What I was thinking about the article was that it's probably another RW scare tactic, perhaps I should have said that from the beginning. Sorry.

Besides I know someone that has used it before and she turned out fine.

Blue

[annarbor]

29. You didn't see the thread in LBN?

Kinda hard to miss...

Ann Arbor

[BlueStorm]

34. No...

Now I'm embarrased :blush: I don't have a lot of time on the computer, plus I have been having a real hard time dealing with my brain fog lately, so that is why I don't post things very good.

As for the person who mentioned my disabled profile, I am very guarded about the info I give out on the Internet. So I usually don't fill out profile forms. A friend of mine somehow had her identity stolen from a message forum, so you can see why I am paranoid about it.

Blue

[phylny]

30. Hi Ann,

I'd say welcome to DU, but I think you've been here longer than I have!

[annarbor]

31. Thanks for the welcome!

Been here a while, but always appreciate a warm welcome!

Ann Arbor

[Freedom_Aflaim]

32. All Medicines have risks

Tragic, but hardly the first time someone had died from the medicine they take

[progressivebydesign]

39. Women should not use it "off-label", that's wrong.

And doctors should not tell them to. This type of off-label use is going to taint the drug to the point where no one will be able to use it.

[pitohui]

51. what's wrong w. it?

women should use drugs as prescribed by their physicians

being "off label" or not is not especially meaningful, it is a financial decision by the manufacturer

"off label" prescribing is done all the time with many, many drugs, it is certainly not something that women should be warned against, rather, it is an option that i want to continue to have open for me, as i have certainly used "off label" drugs and techniques with great safety and with great improvement in my health and quality of life

no drug that works will be 100 percent free of side effects for all people period, that ain't gonna happen, but it's got nothing to do with the label

[pitohui]

48. women die of sepsis in childbirth also

once you're pregnant you're kind of screwed but last time i checked the stats your chance of dying of sepsis in childbirth was greater than sepsis from a legal abortion