Medical Forum / General / Cardiology / December 2004
Gout from Lipitor damage? NAPROXEN increases heart attack risk. BEWARE
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Sharon Hope - 22 Dec 2004 02:03 GMT The FDA warned today that NAPROXEN increases heart attack risk. The radio news story said it was "an arthritis drug." (Gout is considered a form of arthritis)
I called my husband from work to verify the drug that the rheumatologist prescribed for the gout that he gets every time he overworks his Lipitor-damaged muscles.
Sure enough, it was NAPROXEN.
I warned him not to take it any more, and he asked me, "How many Lipitor users develop gout? They need to be warned."
So here it is, folks, the FDA warning issued today on NAPROXEN:
http://www.fda.gov/bbs/topics/news/2004/NEW01148.html
FDA Statement FOR IMMEDIATE RELEASE Statement Dec. 20, 2004 Media Inquiries: 301-827-6242 Consumer Inquiries: 888-INFO-FDA
FDA Statement on Naproxen The FDA today released the following statement on NIH halting a clinical trial involving non-steroidal anti-inflammatory drugs in patients at risk of developing Alzheimer's Disease:
The Food and Drug Administration (FDA) is working with the National Institutes of Health to review the available scientific information on naproxen following the decision of the National Institute on Aging to halt a clinical trial studying non-steroidal anti-inflammatory drugs in patients at risk of developing Alzheimer's disease. Preliminary information from the study showed some evidence of increased risk of cardiovascular events, when compared to placebo, to patients taking naproxen.
In the meantime, FDA advises patients who are currently taking over-the-counter naproxen products to carefully follow the instructions on the label. Patients should not exceed the recommended doses for naproxen (220 milligrams twice daily) and should not take naproxen for longer than ten days unless a physician directs otherwise. Patients with questions about naproxen should consult their physicians.
Naproxen was first sold as a prescription drug under the trade name Naprosyn in 1976. FDA approved its use as an over-the-counter drug in 1994.
####
listener - 22 Dec 2004 03:42 GMT > The FDA warned today that NAPROXEN increases heart attack risk. They did nothing of the sort. Many doctors are confused and upset about the NIH stopping the study. Many doctors have expressed dismay that the NIH and FDA are overreacting to something that is just not understood at this time. BUT LO AND BEHOLD, YOU, Sharon Hope are issuing your "BEWARE!" warning throughout the land!! THE END IS NEAR!
I'll tell ya, this really gets me steamed. It's so reckless and irresponsible. You should be ashamed.
L.
> So here it is, folks, the FDA warning issued today on NAPROXEN: > [quoted text clipped - 34 lines] > > #### Sharon Hope - 22 Dec 2004 05:27 GMT The quote is directly from the FDA website.
No embellishment, just a complete copy of what the FDA said.
Unless your post was a (failed) attempt at humor, your comments should be directed to the FDA.
Per the FDA: "Preliminary information from the study showed some evidence of increased risk of cardiovascular events, when compared to placebo, to patients taking naproxen."
get that? INCREASED RISK OF CARDIOVASCULAR EVENTS
>> The FDA warned today that NAPROXEN increases heart attack risk. > [quoted text clipped - 38 lines] >> >> #### listener - 22 Dec 2004 13:53 GMT Nice creative snipping.
No, my reply was anything *but* humor. The key words in that quote might be "Preliminary" and "some". One of the issues may be very long-term use at high dosages.
I suggest you wait for more definitve information before you begin your drumbeat.
L.
> The quote is directly from the FDA website. > [quoted text clipped - 53 lines] >>> >>> #### Sharon Hope - 23 Dec 2004 03:43 GMT No attempt was claimed to provide definitive information.
The simple post was to alert people who read this board to the fact that the FDA has issued a warning on this drug. Simple, verifiable - go to the link to read it directly from the FDA site.
Although it is not a cardio drug, it was relaed to cardio by the FDA, and I have first-hand knowledge that it is prescribed for people who have Lipitor damage that causes gout. Thus the smc readership need to know.
You can fill up all the computer buffers in the world listing all the things this post was NOT and still miss some from the list. If that is your chosen way to occupy your time, proceed. Consider it my holida gift to you.
Be aware, however, that listing all the things that this post was never meant to be, though perhaps entertaining to you, is not something most people are in need of - they can think for themselves - so please just consider it personal therapy, and enjoy carrying on with your rants, posturing and innuendo! Happy holidays enjoying your favorite hobby!
> Nice creative snipping. > [quoted text clipped - 64 lines] >>>> >>>> #### listener - 23 Dec 2004 04:28 GMT > No attempt was claimed to provide definitive information. > > The simple post was to alert people who read this board to the fact > that the FDA has issued a warning on this drug. Simple, verifiable - > go to the link to read it directly from the FDA site. It would be very hard for anyone NOT to have heard about this since it was on tv, online and in print quite a bit in the last few days. Sharon Hope: self-appointed newsgroup early warning system.
> Although it is not a cardio drug, it was relaed to cardio by the FDA, > and I have first-hand knowledge that it is prescribed for people who [quoted text clipped - 12 lines] > with your rants, posturing and innuendo! Happy holidays enjoying your > favorite hobby! Sarcasm will get you nowhere.
L.
Sharon Hope - 23 Dec 2004 06:15 GMT They may have heard about it as an arthritis drug. None of the reports I read or heard mentioned that
1) Lipitor/statins can induce gout 2) Gout, a form of arthritis, may be treated with one of these drugs, Naproxen or Celebrex 3) The increased heart risk is of concern to anyone, but particularly to those who might be taking a statin precisely to lower that risk
Please provide the links that included this associated information - on tv, online or in print
> It would be very hard for anyone NOT to have heard about this since it > was on tv, online and in print quite a bit in the last few days. Sharon > Hope: self-appointed newsgroup early warning system. zwalanga - 22 Dec 2004 06:09 GMT > > The FDA warned today that NAPROXEN increases heart attack risk. > [quoted text clipped - 6 lines] > I'll tell ya, this really gets me steamed. It's so reckless and > irresponsible. You should be ashamed. ~~~~~~~~~~~~~~~~~~~~
Yes Listener. Physicians are expressing dismay.
"Shelve the Cox-2 inhibitors:" James Wright Therapeutics Initiative
http://tinyurl.com/5fchg
"Jim Wright, a pharmacology professor at the University of British Columbia, said Health Canada should have required continued testing of the drug after it hit the market.
"If that happened, we would have known this, the whole world would have known this," Dr. Wright said in a telephone interview from Vancouver. "Health Canada could easily have said, 'We'll put this on the market, but only on the condition that this trial is done. And at the end of that, they would decide whether they would continue to license it.'"
Dr. Wright, managing director of the Therapeutics Initiative, a B.C. based agency, said Health Canada should "shelve the cox-2 inhibitor class of anti-inflammatory drugs" until further study is carried out on the medication's possible dangers.
"Let's not be using the drugs while we're waiting to find out the problem," he said. "Let's take the cautious approach."
Last week, Health Canada acknowledged that "there has been a lack of published safety data regarding use for longer than one year of selective cox-2 inhibitor" drugs, a new class of anti-inflammatory medications."
~~~~~~~~~~~~~~~~~~~~`
"
> L. > [quoted text clipped - 15 lines] > > > > The Food and Drug Administration (FDA) is working with the National
> > Institutes of Health to review the available scientific information on > > naproxen following the decision of the National Institute on Aging to [quoted text clipped - 17 lines] > > > > #### Dr. Andrew B. Chung, MD/PhD - 22 Dec 2004 05:11 GMT > The FDA warned today that NAPROXEN increases heart attack risk. The radio > news story said it was "an arthritis drug." (Gout is considered a form of [quoted text clipped - 44 lines] > > #### This concern would be extended to all NSAIDs similar to naproxen except aspirin.
Hope the above information helps you.
Such is the work being done here for Christ's glory (http://makeashorterlink.com/?U1E13130A).
Servant to the humblest person in the universe,
Andrew
-- Dr. Andrew B. Chung, MD/PhD Board-Certified Cardiologist http://www.heartmdphd.com/
** Who is the humblest person in the universe? http://makeashorterlink.com/?L26062048
What is all this about? http://makeashorterlink.com/?K6F72510A
Is this spam? http://makeashorterlink.com/?D13B21FF9
Don Kirkman - 24 Dec 2004 01:14 GMT It seems to me I heard somewhere that Sharon Hope wrote in article <CE4yd.269791$HA.187813@attbi_s01>:
>The FDA warned today that NAPROXEN increases heart attack risk. The radio >news story said it was "an arthritis drug." (Gout is considered a form of >arthritis)
>So here it is, folks, the FDA warning issued today on NAPROXEN:
>http://www.fda.gov/bbs/topics/news/2004/NEW01148.html Sharon, please highlight the section of this report that warned of increased heart attack risk from Naproxen. I can't find it.
What I do find is that the FDA issued a statement that: - they are working with NIH to review information - they advise patients using OTC naproxen to follow the usage recommendations of the manufacturer - they advise patients using naproxen to consult with their doctors
I'm leaving the report intact so you can underline or highlight the warning language.
>FDA Statement >FOR IMMEDIATE RELEASE >Statement >Dec. 20, 2004 >Media Inquiries: 301-827-6242 >Consumer Inquiries: 888-INFO-FDA
>FDA Statement on Naproxen >The FDA today released the following statement on NIH halting a clinical >trial involving non-steroidal anti-inflammatory drugs in patients at risk of >developing Alzheimer's Disease:
>The Food and Drug Administration (FDA) is working with the National >Institutes of Health to review the available scientific information on [quoted text clipped - 3 lines] >study showed some evidence of increased risk of cardiovascular events, when >compared to placebo, to patients taking naproxen.
>In the meantime, FDA advises patients who are currently taking >over-the-counter naproxen products to carefully follow the instructions on >the label. Patients should not exceed the recommended doses for naproxen >(220 milligrams twice daily) and should not take naproxen for longer than >ten days unless a physician directs otherwise. Patients with questions about >naproxen should consult their physicians.
>Naproxen was first sold as a prescription drug under the trade name Naprosyn >in 1976. FDA approved its use as an over-the-counter drug in 1994.  Signature Don donkirk@covad.net
listener - 24 Dec 2004 04:21 GMT Don,
Didn't you see:
"Preliminary information from the study showed some evidence of increased risk of cardiovascular events..."
There it is, clear as a bell. Right?
L.
> It seems to me I heard somewhere that Sharon Hope wrote in article > <CE4yd.269791$HA.187813@attbi_s01>: [quoted text clipped - 51 lines] >>Naprosyn in 1976. FDA approved its use as an over-the-counter drug in >>1994. Sharon Hope - 24 Dec 2004 05:13 GMT Synonymous, for example the study abstract http://jama.ama-assn.org/cgi/content/abstract/286/8/954
JAMA, Vol. 286, No. 8, August 22, 2001, Risk of Cardiovascular Events Associated With Selective COX-2 Inhibitors Debabrata Mukherjee, MD; Steven E. Nissen, MD; Eric J. Topol, MD
JAMA. 2001;286:954-959.
Author Affiliations: Department of Cardiovascular Medicine, The Cleveland Clinic Foundation, Cleveland, Ohio.
"cardiovascular event (myocardial infarction, stroke, and death) "
And , per NIH Medical Encyclopedia: http://www.nlm.nih.gov/medlineplus/ency/article/000195.htm Definition: A heart attack (myocardial infarction) occurs when an area of heart muscle dies or is permanently damaged because of an inadequate supply of oxygen to that area.
Thus the synonymous "cardiovascular event" , "myocardial infarction", and the common vernacular "heart attack"
> It seems to me I heard somewhere that Sharon Hope wrote in article > <CE4yd.269791$HA.187813@attbi_s01>: [quoted text clipped - 54 lines] >>Naprosyn >>in 1976. FDA approved its use as an over-the-counter drug in 1994. Don Kirkman - 24 Dec 2004 23:40 GMT It seems to me I heard somewhere that Sharon Hope wrote in article <mANyd.281110$HA.94857@attbi_s01>:
>Synonymous, for example the study abstract >http://jama.ama-assn.org/cgi/content/abstract/286/8/954
>JAMA, Vol. 286, No. 8, August 22, 2001, >Risk of Cardiovascular Events Associated With Selective COX-2 Inhibitors >Debabrata Mukherjee, MD; Steven E. Nissen, MD; Eric J. Topol, MD
>JAMA. 2001;286:954-959.
>Author Affiliations: Department of Cardiovascular Medicine, The Cleveland >Clinic Foundation, Cleveland, Ohio.
>"cardiovascular event (myocardial infarction, stroke, and death) "
>And , per NIH Medical Encyclopedia: >http://www.nlm.nih.gov/medlineplus/ency/article/000195.htm >Definition: A heart attack (myocardial infarction) occurs when an area of >heart muscle dies or is permanently damaged because of an inadequate supply >of oxygen to that area.
>Thus the synonymous "cardiovascular event" , "myocardial infarction", and >the common vernacular "heart attack" The definition of "heart attack" and its cognates is not at issue; you said the FDA *warned* of additional risk of heart attack. Where is that warning to be found?
 Signature Don donkirk@covad.net
Sharon Hope - 25 Dec 2004 02:08 GMT The FDA advisory includes specific instructions to patients. That quite obviously constitutes a warning. That is why the news media made it so widely known.
You may split hairs with the FDA if you object to the words they chose, but it is clear that the advisory is a warning.
> It seems to me I heard somewhere that Sharon Hope wrote in article > <mANyd.281110$HA.94857@attbi_s01>: [quoted text clipped - 26 lines] > said the FDA *warned* of additional risk of heart attack. Where is that > warning to be found? listener - 25 Dec 2004 15:23 GMT > The FDA advisory includes specific instructions to patients. That > quite obviously constitutes a warning. That is why the news media > made it so widely known. > > You may split hairs with the FDA if you object to the words they > chose, but it is clear that the advisory is a warning. In some circles it's known as "critical thinking" which, apparently, when you do it (to a degree) it's fine but when others do it you dismiss it, ridicule it or ignore it.
Sophomoric L.
>> It seems to me I heard somewhere that Sharon Hope wrote in article >> <mANyd.281110$HA.94857@attbi_s01>: [quoted text clipped - 27 lines] >> you said the FDA *warned* of additional risk of heart attack. Where >> is that warning to be found? Don Kirkman - 25 Dec 2004 21:37 GMT It seems to me I heard somewhere that Sharon Hope wrote in article <gY3zd.237326$5K2.175138@attbi_s03>:
>The FDA advisory includes specific instructions to patients. That quite >obviously constitutes a warning. That is why the news media made it so >widely known.
>You may split hairs with the FDA if you object to the words they chose, but >it is clear that the advisory is a warning. Actually they did not use the words "warn[ing]" nor did they say categorically that Naproxen "increases heart attack risk;" those are your words that are being called into question. An advisory is just that, information about a possible event that a person with common sense would watch out for; a warning is information about a clear and present danger--don't you distinguish between a tornado advisory and a tornado warning? The weather service does.
[Balance snipped to save space; the full text is available in other messages]
 Signature Don donkirk@covad.net
Sharon Hope - 26 Dec 2004 04:39 GMT Which is why I included the FDA wording with mine. YMMV
> It seems to me I heard somewhere that Sharon Hope wrote in article > <gY3zd.237326$5K2.175138@attbi_s03>: [quoted text clipped - 17 lines] > [Balance snipped to save space; the full text is available in other > messages] zwalanga - 25 Dec 2004 03:47 GMT > It seems to me I heard somewhere that Sharon Hope wrote in article > <mANyd.281110$HA.94857@attbi_s01>: [quoted text clipped - 28 lines] > Don > donkirk@covad.net This warning, couched as carefully as it has been, will most certainly have been done to give away as little as possible,while still meeting requisites for legal disclaimer should some unfortunate soul(s) ever decide Naproxen damage constitutes a class action. But having played big game law, you knew that, didn't you Don.
Don Kirkman - 25 Dec 2004 21:37 GMT It seems to me I heard somewhere that zwalanga wrote in article <1103946428.336622.50320@z14g2000cwz.googlegroups.com>:
>> It seems to me I heard somewhere that Sharon Hope wrote in article >> <mANyd.281110$HA.94857@attbi_s01>: [...]
>> >Thus the synonymous "cardiovascular event" , "myocardial >infarction", and >> >the common vernacular "heart attack"
>> The definition of "heart attack" and its cognates is not at issue; >you >> said the FDA *warned* of additional risk of heart attack. Where is >that >> warning to be found?
>This warning, couched as carefully as it has been, will most certainly >have been done to give away as little as possible,while still meeting >requisites for legal disclaimer should some unfortunate soul(s) ever >decide Naproxen damage constitutes a class action. But having played >big game law, you knew that, didn't you Don. Couched so carefully it can't be found, Zee. A suggestion is not a warning, either in law or in common sense. And don't misinterpret what I wrote early as my having "played big game law;" I specifically said I am not a lawyer though I worked with and among lawyers and other justice system folks for most of my career.
 Signature Don donkirk@covad.net
zwalanga - 25 Dec 2004 22:16 GMT > It seems to me I heard somewhere that zwalanga wrote in article > <1103946428.336622.50320@z14g2000cwz.googlegroups.com>: [quoted text clipped - 28 lines] > Don > donkirk@covad.net I did not misinterpret what you did Don. ~Heh~ I know the difference.
I also know, and you know too, that this statement would be presented as having been warning in a law suit undertaken on behalf of one injured by naproxen. And it would be presented as such by the defendents.
This advisory is a warning. Legally. And that is just why it was done. So that in the event of law suits, pharma can say it warned. And then legally, the burden bounces back to the injured. Whether or not a case could be won or lost on this alone is moot.
This is warning. This is legal.
Split hairs all you like. Pharma warned. They're clear from here on for anyone taking that medication NOW. Sharon had it right.
Beware.
Zee
Don Kirkman - 26 Dec 2004 08:43 GMT It seems to me I heard somewhere that zwalanga wrote in article <1104012962.659790.43240@c13g2000cwb.googlegroups.com>:
>> It seems to me I heard somewhere that zwalanga wrote in article >> <1103946428.336622.50320@z14g2000cwz.googlegroups.com>:
>> >> It seems to me I heard somewhere that Sharon Hope wrote in article >> >> <mANyd.281110$HA.94857@attbi_s01>:
>> [...]
>> >> >Thus the synonymous "cardiovascular event" , "myocardial >> >infarction", and >> >> >the common vernacular "heart attack"
>> >> The definition of "heart attack" and its cognates is not at issue; >> >you >> >> said the FDA *warned* of additional risk of heart attack. Where >is >> >that >> >> warning to be found?
>> >This warning, couched as carefully as it has been, will most >certainly [quoted text clipped - 4 lines] >> >decide Naproxen damage constitutes a class action. But having played >> >big game law, you knew that, didn't you Don.
>> Couched so carefully it can't be found, Zee. A suggestion is not a >> warning, either in law or in common sense. And don't misinterpret [quoted text clipped - 4 lines] >justice >> system folks for most of my career.
>I did not misinterpret what you did Don. ~Heh~ I know the difference. <G>
>I also know, and you know too, that this statement would be presented >as having been warning in a law suit undertaken on behalf of one >injured by naproxen. And it would be presented as such by the >defendents.
>This advisory is a warning. Legally. And that is just why it was done. >So that in the event of law suits, pharma can say it warned. And then >legally, the burden bounces back to the injured. Whether or not a case >could be won or lost on this alone is moot.
>This is warning. This is legal. Can you give me a case citation or a reference to legislation equating advise with warning? What legislature or what court deemed an advisory to be a warning?
>Split hairs all you like. Pharma warned. They're clear from here on for >anyone taking that medication NOW. >Sharon had it right. I'm not splitting hairs, I'm parsing English statements.
 Signature Don donkirk@covad.net
zwalanga - 26 Dec 2004 14:10 GMT > It seems to me I heard somewhere that zwalanga wrote in article > <1104012962.659790.43240@c13g2000cwb.googlegroups.com>: [quoted text clipped - 64 lines] > Don > donkirk@covad.net If it wasn't perceived as a legal threat they wouldn't be doing this. The next step will be a stronger "advisory" warning people, or an "advisory" pulling the drug. The document is the advisory. What it is doing is warning.
This is legal telling communications "say this". And the reason they are doing it is legal.
Zee
William Wagner - 26 Dec 2004 15:14 GMT > If it wasn't perceived as a legal threat they wouldn't be doing this. > The next step will be a stronger "advisory" warning people, or an [quoted text clipped - 6 lines] > > Zee Found these two below.
Posted on Sat, Dec. 25, 2004
http://www.philly.com/mld/inquirer/news/nation/10496237.htm
No whistle-blower protection for many
Federal medical workers may be fired for reporting alleged wrongs, a judge ruled in an NIH case.
By John Solomon
Associated Press
WASHINGTON - Thousands of federal doctors and medical researchers who receive some of the highest salaries in government do not enjoy the same protections to blow the whistle on wrongdoing as other civil servants, a judge has ruled.
Administrative Judge Raphael Ben-Ami of the U.S. Merit Systems Protection Board ruled recently that Dr. Jonathan Fishbein, a National Institutes of Health specialist, could not seek the board's protection from firing under the Whistleblower Protection Act.
Fishbein was hired by NIH in 2003 to help improve AIDS research practices. He alleges he is being fired because he uncovered concerns about sloppy research practices that might endanger patient safety.
NIH said that he was being fired for poor performance and described a "disgruntled" employee who failed to make his two-year probation period.
Fishbein is a "Title 42" employee and is paid $178,000 a year, slightly more than the $175,700 that members of President Bush's Cabinet receive.
Title 42 of the federal code allows the government to pay research and medical experts as special consultants and give them salaries higher than the civil servant maximums. The law is designed to help the government compete against high-paying private industries.
NIH employs more than 3,959 Title 42 workers, and the Centers for Disease Control and Prevention employs 200 to 300, according to the Department of Health and Human Services.
Ben-Ami ruled Nov. 9 that Fishbein was not covered by the Whistleblower Protection Act because he is a Title 42 employee and has "no appeal rights" during his two-year probationary period.
"Title 42 appointments of special consultants are made without regard to the civil service laws," and therefore they are not permitted to appeal to the Merit Systems Protection Board under the whistle-blower law, he ruled. "The board lacks authority to consider the appellants' claims of discrimination or retaliation."
Fishbein's lawyers are appealing to the full board.
The whistle-blower law was passed more than a decade ago to strengthen federal workers' protections when they raise allegations of federal wrongdoing, giving them outlets such as the board and the U.S. Office of Special Counsel to seek legal protection.
The National Whistleblower Center, based in Washington, is urging Congress to fix what it called a "dangerous loophole."
"This is a major setback for drug safety," said Kris Kolesnik, the center's executive director. "Many of these employees, such as Dr. Fishbein, hold sensitive health- and safety-related positions. Without protections, these employees will not blow the whistle."
The Associated Press reported last week that Fishbein was among several NIH employees who raised concerns in 2002 about a study in Africa involving the AIDS drug nevirapine.
Documents showed that the way the research was conducted violated federal patient safety rules and suffered from record-keeping and patient monitoring problems. But the study's general conclusion that the drug could be used safely in single doses to protect babies from HIV was upheld.
Steve Kohn, Fishbein's attorney, said federal agencies including NIH have markedly increased their recruitment and hiring of employees under Title 42 in recent years, leaving an entire class of workers without whistle-blower protections.
Kohn said, "It's a game of cat and mouse, in which the real losers are the American people."
????????????????????.
Perhaps of interest also.
Jurdy's Blog on Big Pharmaceutical NewsJurdy's Blog on Big Pharmaceutical News
http://www.jurdy.net/
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Happy Holidays!
Bill
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Don Kirkman - 26 Dec 2004 22:54 GMT It seems to me I heard somewhere that zwalanga wrote in article <1104070239.572380.231860@z14g2000cwz.googlegroups.com>:
I don't want to drag this out, but . . .
>> It seems to me I heard somewhere that zwalanga wrote in article >> <1104012962.659790.43240@c13g2000cwb.googlegroups.com>:
>> >> It seems to me I heard somewhere that zwalanga wrote in article >> >> <1103946428.336622.50320@z14g2000cwz.googlegroups.com>: [. . .]
Zee wrote:
>> >> >This warning, couched as carefully as it has been, will most >> >certainly [quoted text clipped - 5 lines] >played >> >> >big game law, you knew that, didn't you Don. I wrote:
>> >> Couched so carefully it can't be found, Zee. A suggestion is not >a >> >> warning, either in law or in common sense. [...]
>> >I also know, and you know too, that this statement would be >presented >> >as having been warning in a law suit undertaken on behalf of one >> >injured by naproxen. And it would be presented as such by the >> >defendents.
>> >This advisory is a warning. Legally. And that is just why it was >done. [quoted text clipped - 5 lines] >> >> >This is warning. This is legal.
>> Can you give me a case citation or a reference to legislation >equating >> advise with warning? What legislature or what court deemed an >advisory >> to be a warning?
>If it wasn't perceived as a legal threat they wouldn't be doing this. >The next step will be a stronger "advisory" warning people, or an >"advisory" pulling the drug. The document is the advisory. What it is >doing is warning.
>This is legal telling communications "say this". >And the reason they are doing it is legal. I think I see the problem now. You're not talking about a warning to the users but to the company itself: "legal telling communications 'say this.' But Sharon wasn't talking in those terms at all, she was talking about the FDA warning users about cardiac risk.
 Signature Don donkirk@covad.net
zwalanga - 26 Dec 2004 23:39 GMT The FDA does not write the advisory/warning. Pharma does. In this case, Pfizer. Pfizer's legal department and Pfizer's communications department sit down and write this. Legal tells communications what must be said and not, it goes through many drafts. But none of them are done by the FDA (or Health Canada).
The FDA then publishes the warning. But it has not authored it, and any summaries or precis of this warning though written by the FDA would have to be veted through Pfizer's legal and communications again.
Sorry. At the very least it is an advisory that warns. Semantics. But hey, I can riff on this as long as you like. Part of my linguistic rehab. Zee
> It seems to me I heard somewhere that zwalanga wrote in article > <1104070239.572380.231860@z14g2000cwz.googlegroups.com>: [quoted text clipped - 62 lines] > this.' But Sharon wasn't talking in those terms at all, she was talking > about the FDA warning users about cardiac risk. Hawki63 - 24 Dec 2004 23:58 GMT >Subject: Re: Gout from Lipitor damage? NAPROXEN increases heart attack risk. >BEWARE >From: "Sharon Hope" shope@anet.net >Date: 12/23/2004 9:13 PM Pacific Standard Time >Message-id: <mANyd.281110$HA.94857@attbi_s01>
>Risk of Cardiovascular Events Associated With Selective COX-2 Inhibitors except that Naproxen is NOT a Cox II
please read the potential adverse effects of ....say...aspirin...
bleeding will be number one...does that mean that aspirin is BAD....course not..
also please list ANY pill,,potion..supplement or herb that has NOOOOO potential adverse effects/..
cannot be done..any substance ingested has potential adverse effects...
one must weigh the risks to the benefits..
which you and others refuse to do...
you harp only on the risks..
sorry..
hawki.....
zwalanga - 25 Dec 2004 00:25 GMT > >Subject: Re: Gout from Lipitor damage? NAPROXEN increases heart attack risk. > >BEWARE [quoted text clipped - 25 lines] > > hawki..... Speaking of things others refuse to do Hawki..how about diet and exercise to control diabetes 2, obesity and cholesterol levels instead of taking the high tech road? Don't give me no whine about that knee.
Zee
Hawki63 - 25 Dec 2004 18:54 GMT >Subject: Re: Gout from Lipitor damage? NAPROXEN increases heart attack risk. >BEWARE >From: "zwalanga" zwalanga@yahoo.com >Date: 12/24/2004 4:25 PM Pacific Standard Time >Message-id: <1103934340.468640.54960@c13g2000cwb.googlegroups.com>
>Speaking of things others refuse to do Hawki..how about diet and >exercise to control diabetes 2, obesity and cholesterol levels instead >of taking the high tech road? >Don't give me no whine about that
>knee. why Zee...how nice of you...
actually it is NOT only "that knee"...but also a degenerative tendon on the opposite ankle...that I have been nursing for the past two years..
this holiday season with its increased walking,,shopping...etc..made it perfectly clear that surgery is the only answer..this time ...BIG surgery...as I need a "tendon transplant"..actually the surgery is not that bad...but two surgeons warn me that the rehab can take 6-12 months!!!
please do not lecture me on "walking" as a cure for my lipid problems...as I can barely get around my house..
and calling it a "whine" only demonstrates how little you know about orthopedic infirmities..
and BTW I do NOT have diabetes!!!
and BTW...with all your walking etc...are your lipids much lower than 500 yet?? hawki.....
zwalanga - 25 Dec 2004 20:16 GMT > >Subject: Re: Gout from Lipitor damage? NAPROXEN increases heart attack risk. > >BEWARE [quoted text clipped - 29 lines] > and BTW...with all your walking etc...are your lipids much lower than 500 yet?? > hawki..... Why Hawki how nice of you....to respond to a woman watching her husband live 1/4 of the life he might have, live through daily excrutiating pain, see her retirement income and savings depleted, business lost, wonder if next they will lose their home, see her children and grandchildren cry over this different father and grandfather...and be so callously and easily sarcastic to her. On the eve of a day she celebrates.
I have a back fused in two places with metal brackets and screws as long as your longest finger, and lived through one of the screws moving and damaging my spinal nerves further. The implants weren't done lightly. I greatly disabled an in excruciating pain daily before I consented, but not until I had lost control of bowel and bladder.
I spent six months in orthopaedic rehabiliation. I know a LOT about orthopaedic rehab. Following that, still with nerve damage and attendent disabilities both because of the screw moving and the failure of the fusions to correct my spondylolisthesis and scoliosis, I followed the 2 1/2 hour workout of my Everest summitting nephew. Everyday: gym, weight lifting, treadmill, stretching, pool work, swimming, running cross-country. At the peak of my physical ability, I was started on statins. Don't give me any whine about that knee.
Zee
Hawki63 - 26 Dec 2004 21:09 GMT >Subject: Re: Gout from Lipitor damage? NAPROXEN increases heart attack risk. >BEWARE >From: "zwalanga" zwalanga@yahoo.com >Date: 12/25/2004 12:16 PM Pacific Standard Time >Message-id: <1104005785.594559.74170@f14g2000cwb.googlegroups.com>
>Why Hawki how nice of you....to respond to a woman watching her husband >live 1/4 of the life he might have, live through daily excrutiating >pain, see her retirement income and savings depleted, business lost, >wonder if next they will lose their home, see her children and >grandchildren cry over this which all has nothing to do with your snipe at me for "whining"
>I spent six months in orthopaedic rehabiliation. I know a LOT about >orthopaedic rehab. Following that, still with nerve damage and >attendent disabilities both because of the screw moving and the failure >of the fusions to correct my spondylolisthesis and scoliosis, I
>Don't give me any whine about that knee. ie....one CANNOT walk for exercise with the injuries that I have.. and "running cross country"...surely you do NOT understand that problems in different parts of one orthopedic structure mean different things...
if you can run cross country..you obviously do not need a tendon transplant in your ankle..
not to mention that my other leg..as a result of a MVA 27 years ago..has 3 pins in its ankle..no patella in its knee..
there is no comparision
one CAN walk etc with spinal problems
BTW...I also have had a spinal fusion..
.">Don't give me any whine about that knee.
if only that was the only source of my whine..
hawki.....
zwalanga - 26 Dec 2004 23:18 GMT > >Subject: Re: Gout from Lipitor damage? NAPROXEN increases heart attack risk. > >BEWARE [quoted text clipped - 9 lines] > > which all has nothing to do with your snipe at me for "whining" It was not a snipe actually, until you over-reacted with what then was most definitely a lamo whine.
> >I spent six months in orthopaedic rehabiliation. I know a LOT about > >orthopaedic rehab. Following that, still with nerve damage and [quoted text clipped - 6 lines] > and "running cross country"...surely you do NOT understand that problems in > different parts of one orthopedic structure mean different things... Why yes I do understand Hawki. I understand that a woman who can run around the malls shopping could work out and exercise. But she gets more strokes from whining. I also understand that statins cause myopathy (weakness and atrophy) and tendonitis. So even if you had your proclivities prior to taking statins (as did I) the statins are going to make everything worse.
Did I mention my hip surgery? Removal of the trocanteric bursa, and a tie back on the tensor fascialata? All kinds of knee problems from that. Then there's the right leg over one-half inch shorter than the left, kinda plays fast and loose with my instrumented fusion (the lumbar one).
> if you can run cross country..you obviously do not need a tendon transplant in > your ankle.. I didn't get off the surgery guerney and start running cross country. It took me two years, including six month of formal rehab. It was a lot of tears, pain and determination.
And NO time spent shopping and running around the mall and making excuses for myself.
> not to mention that my other leg..as a result of a MVA 27 years ago..has 3 pins > in its ankle..no patella in its knee.. > > there is no comparision Sure there is. You are whining, long past injury, several months past surgery and whining that you cannot do gym rehab, but you can run around the mall.
> one CAN walk etc with spinal problems > > BTW...I also have had a spinal fusion.. Instrumented? Failed, with a bone fusion that snapped when you fell in the hospital? And then the pedicle screw (one of eight) moved?
> .">Don't give me any whine about that knee. > > if only that was the only source of my whine.. You are welcome to my sympathy. But not your excuses. Zee
> hawki..... Hawki63 - 27 Dec 2004 08:26 GMT >Subject: Re: Gout from Lipitor damage? NAPROXEN increases heart attack risk. >BEWARE >From: "zwalanga" zwalanga@yahoo.com >Date: 12/26/2004 3:18 P.M. Pacific Standard Time >Message-id: <1104103122.552592.305080@c13g2000cwb.googlegroups.com>
>Why yes I do understand Hawki. I understand that a woman who can run >around the malls shopping could work out and exercise. But she gets >more strokes from whining. I al ya know...I have had more than enuf of your know it all yammerring
NOWHERE did I state that I was "running around malls shopping"...what I mentioned was that even attempting to do usual holiday stuff has made it perfectly clear that this ankle tendon transplant can no longer be put off...
HOW you misread that is beyond me...YOU are the one still continuing to ONLY focus on a knee repair of a mere two months ago(??) ...which you call a "whine"..
>I also understand that statins cause >myopathy (weakness and atrophy) and tendonitis. So even if you had your >proclivities prior to taking statins (as did I) the statins are going >to make everything worse. if you had half the knowledge you think you did...you would be dangerous...
I have been on statins for about a year....
I do NOT have tendonitis...nor "weakness"...what I have is a tendon that is totally degenerated..."frayed like a rope" is how it was described to me....this diagnosis preceded my statin therapy by more than a year...two orthos explained that such degeneration (in my case) are the result of the 27 years of walking with a funny gait due to injuries to my OTHER leg...
so get off your "statins caused it" ...as you know nothing of the anatomy and pathophysiology of my ankle...
>> if you can run cross country..you obviously do not need a tendon >transplant in >> your ankle.. which I do...NOW...whine?? you bet ya??
>And NO time spent shopping and running around the mall and making >excuses for myself. oh...f off you biddy
>Sure there is. You are whining, long past injury, several months past >surgery and whining that you cannot do gym rehab, but you can again....read the above..my "whine" is of TODAY....not of long past injuries...it was YOU keeping score of who hurts the worst
>cannot do gym rehab, but you can run >around the mall. bullshit...
>> BTW...I also have had a spinal fusion.. > >Instrumented? Failed, with a bone no...I had a decent surgeon..
>You are welcome to my sympathy. But not your excuses. >Zee I do not want ...nor need ...either...
lots of luck with your lipids..
hawki.....
listener - 27 Dec 2004 13:12 GMT >>Subject: Re: Gout from Lipitor damage? NAPROXEN increases heart attack >>risk. BEWARE [quoted text clipped - 73 lines] > > hawki..... Next: She'll attribute your "obvious hostility" to your statin!
The only way to deal with zee's rude, arrogant, dismissive and misinformed manner is to killfile her.
L.
Hawki63 - 27 Dec 2004 17:43 GMT >Subject: Re: Gout from Lipitor damage? NAPROXEN increases heart attack risk. >BEWARE >From: listener listener@nospam.net >Date: 12/27/2004 5:12 AM Pacific Standard Time >Message-id: <Xns95CC53EADED77some1outthere@38.144.126.102> snip
>The only way to deal with zee's rude, arrogant, dismissive and >misinformed manner is to killfile her. > >L. yes...you are correct...and I plan on doing just that from now on..
thanks hawki.....
Hawki63 - 28 Dec 2004 00:16 GMT >Subject: Re: Gout from Lipitor damage? NAPROXEN increases heart attack risk. >BEWARE >From: hawki63@aol.com (Hawki63) >Date: 12/27/2004 9:43 AM Pacific Standard Time >Message-id: <20041227124302.06404.00002142@mb-m18.aol.com> just returned from the orthopedist's.....with cast on left ankle up to knee..for next 4 weeks..
hmmm...wonder if I am allowed to whine yet???
hawki.....
William Wagner - 28 Dec 2004 00:44 GMT > >Subject: Re: Gout from Lipitor damage? NAPROXEN increases heart attack risk. > >BEWARE [quoted text clipped - 8 lines] > > hawki..... Keep it elevated and complain of pain to your family members. Or as my adult children say ....chill. Hope it goes well.
Bill
 Signature Zone 5 S Jersey USA Shade Serious Vision Problems like Starghart?s ? --> http://www.ocutech.com/
zwalanga - 28 Dec 2004 00:52 GMT Your usual the-more-intervention-the-better choice. The wrong choice. It can only lead to more intervention.
You will experience atrophy, weakening and predispose to more injury both there and in the compensating joints ligaments and tendons.
A better choice would have been to start conisistent active rehab. Several months or years ago.
Zee
> >Subject: Re: Gout from Lipitor damage? NAPROXEN increases heart attack risk. > >BEWARE [quoted text clipped - 8 lines] > > hawki.... Hawki63 - 28 Dec 2004 01:29 GMT >Subject: Re: Gout from Lipitor damage? NAPROXEN increases heart attack risk. >BEWARE >From: "zwalanga" zwalanga@yahoo.com >Date: 12/27/2004 4:52 PM Pacific Standard Time >Message-id: <1104195147.837890.212240@z14g2000cwz.googlegroups.com>
>Your usual the-more-intervention-the-better choice. The wrong choice. >It can only lead to more intervention. You truly never cease to amaze me with your totally non educated solutions to problems that need an education to evaluate
"the wrong choice??"" "will lead to more intervention??"""
actually the goal is relief of pain and inflammmation secondary to immobilization..
>You will experience atrophy, weakening and predispose to more
>injury >both there and in the compensating joints ligaments and tendons. LOL LOL...how pathetic...
when you get board certified in ortho and can read MRI's...come around again..in the meantime..your lack of knowledge of my problem is so laughable it is laughable..
>A better choice would have been to start conisistent active rehab. >Several months or years ago. again....LOL LOL LOL
you are still assuming I have "tendonitis"...which I have told you I have not..
do yourself a favor and do some research on "ankle tendon transplant" et al....
and learn something about pathophysiology..
and shut the f... up...
ps....this injury CANNOT be made worse...and actually the cast is to HELP the other structures gain some strength and mobility..
the tendon is shot...
but again....lecture to someone who has less brains than you..if such a person reads this group..
lady...you are a pathetic wannabe non educated medical know nothing..
hawki.....
listener - 28 Dec 2004 01:52 GMT >>Subject: Re: Gout from Lipitor damage? NAPROXEN increases heart attack >>risk. BEWARE [quoted text clipped - 5 lines] >>injury >>both there and in the compensating joints ligaments and tendons. Wow. I imagine zee hunched over her crystal ball, massaging it lovingly, intoning those words in a thick accent......(think female bela lugosi).
A hoot!
L.
Hawki63 - 28 Dec 2004 01:58 GMT >Subject: Re: Gout from Lipitor damage? NAPROXEN increases heart attack risk. >BEWARE >From: listener listener@nospam.net >Date: 12/27/2004 5:52 PM Pacific Standard Time >Message-id: <Xns95CCD55E26882some1outthere@38.144.126.109>
>>You will experience atrophy, weakening and predispose to more >> >>>injury >>>both there and in the compensating joints ligaments and tendons. says Zee...not a specialist in any medical field...not even good at researching
>Wow. I imagine zee hunched over her crystal ball, massaging it lovingly, >intoning those words in a thick accent......(think female bela lugosi). > >A hoot! yeah....i thought so too...tho it is beyond the bend in ridiculousness that she feels herself qualified to make such judgements...
as I told her...come back when she is board certified in ortho ...and maybe I will stop feeling sorry for her need for ego boosting posts such as this///
hawki.....
zwalanga - 28 Dec 2004 02:11 GMT You continue to think the more intervention you have the better. You do not need a cast, you just need to quit running the mall. Immobilize yes, but there are better ways, and you will not find them at an orthopaedic surgeons office. (He has probably already booked the surgery this will hasten you toward).
You also did not need an MRI, partictularly since you are seeing such a hot shot orthopod. Could he not have diagnosed this without uber technology?
I am not assuming you are being treated for tendonitis. You might have that, on top of anything else you have malpractised your way into, thinking the more interventions you have the more real is your problem.
There are experts who could have helped you long ago, but they are not surgeons, and you would have had to do the major work. Nah. That is not your style.
Hawki63 - 28 Dec 2004 03:21 GMT >Subject: Re: Gout from Lipitor damage? NAPROXEN increases heart attack risk. >BEWARE >From: "zwalanga" zwalanga@yahoo.com >Date: 12/27/2004 6:11 PM Pacific Standard Time >Message-id: <1104199909.444966.242440@z14g2000cwz.googlegroups.com>
>You continue to think the more intervention you have the better and you continue to amaze me with your idiocy..and total inability to read for comprehension..perhaps they don't teach first graders that in Canada
how sad
>You do >not need a cast, you just need to quit running the mall. please return to my inital post ...I never said I was "running the mall"
Immobilize?? for the two years since this was diagnosed?? or the 27 years since the injury that caused my uneven gait?? yeah right..
>mmobilize >yes, but there are better ways, and you will not find them at an >orthopaedic surgeons office. oh pray tell..oh surgeon wannabe...what you see in that crazy crystal ball...
>You also did not need an MRI, partictularly since you are seeing such a >hot shot orthopod. Could he not have diagnosed this without uber >technology? ahhh...again you demonstrate your total lack of knowledge in this area..
NO....only the "uber technology" would do..few mortal folks can see inside the anatomy...
no swelling no redness..no inflammation...
oh but I suppose you figure xrays to diagnose fractures are passe as well...what an idiot
>I am not assuming you are being treated for tendonitis. You might have >that, on top of anything else you have malpractised your way into, >thinking the more interventions you have the more real is your problem look up tendonitis..and come back and post the signs and symptoms...
"more real is my problem??""'
yikes...asif I need verification...
but then...you think your "running around" will offset your lipids of over 500...you are a pathetic being...who likely will be caught in your own big mouth sooner than later..
>There are experts who could have helped you long ago, but they are not >surgeons, and you would have had to do the major work. >Nah. That is not your style. oh how cute.......yep...PT and all that...yep...bet you plan on removing your own cancerous organs as well...who needs experts??
when one has a brain the size of a pea..and an ego the size of an elephant..
hawki.....
zwalanga - 28 Dec 2004 00:58 GMT And still you keep reading me. Y
You are flipping hilarious. Pay nospam a monthly fee so you can log on, kill-file virtually everyone then proceed to read those same people and respond to them through a third party. I have known five-year olds who have grown out of that kind of rational.
You do need a nurse.
Zee
> >>Subject: Re: Gout from Lipitor damage? NAPROXEN increases heart attack > >>risk. BEWARE [quoted text clipped - 80 lines] > > L. listener - 25 Dec 2004 20:22 GMT >>Subject: Re: Gout from Lipitor damage? NAPROXEN increases heart attack >>risk. BEWARE [quoted text clipped - 31 lines] > and BTW...with all your walking etc...are your lipids much lower than > 500 yet?? hawki..... Uh, oh...me thinks you're about to get an earful from zee (the victim).
L.
zwalanga - 25 Dec 2004 22:00 GMT > >>Subject: Re: Gout from Lipitor damage? NAPROXEN increases heart attack > >>risk. BEWARE [quoted text clipped - 35 lines] > > L. What do you call someone with minor heartbeat irregularities who refers to himself as "Afibber" (finally he can call himself something) swallows a truckload of medications to treat this big nothing, and without heart disease, takes medications for that too. Then, he takes medications to treat the adverse effects these unneeded medications cause.
Hypochondriac...Wuss...Fool... Victim?
Definitely.
Zee
Sharon Hope - 25 Dec 2004 02:03 GMT Again, the post was a copy of what the FDA said, not me. If the FDA's statement is counter to your perceptions about risk, that is between you and the FDA.
> >Subject: Re: Gout from Lipitor damage? NAPROXEN increases heart attack > >risk. [quoted text clipped - 27 lines] > > hawki..... Frankie - 25 Dec 2004 21:53 GMT Source: http://www.nih.gov/news/pr/dec2004/od-20.htm
The trial that started the chain of events: Alzheimer's Disease Anti-Inflammatory Prevention Trial [ADAPT] ADAPT was launched Jan 31, 2001, sponsored by NIA.
QUOTE: Data from the ADAPT trial indicated an apparent increase in cardiovascular and cerebrovascular events among the participants taking naproxen when compared with those on placebo. END QUOTE ******************************************************************* Source: http://www.alz.org/news/04q4/122104.asp
QUOTE: The suspension came after data from the Alzheimer's Disease Anti-Inflammatory Prevention Trial (ADAPT) linked naproxen to an increased risk of "heart attack" and "stroke".
FDA officials called the situation with regard to NSAID safety "confusing." The agency is in the process of reviewing all available data about the drugs and will hold a meeting in February to discuss future regulatory implications. END QUOTE ******************************************************************* "hold a meeting in Februrary" ???? What's wrong with now??? ******************************************************************* Source: http://www.nia.nih.gov/ I was shocked not to see any info at all as to the latest status of the ADAPT Trials, as NIA sponsors this trial. ******************************************************************* Naproxin Info Source: http://www.drugs.com/naproxen.html Who should not take naproxen? · Before taking this medication, tell your doctor if you · have an allergy to aspirin or any other NSAIDs · have an ulcer or bleeding in your stomach · drink more than three alcoholic beverages a day · have liver disease · have kidney disease · have a coagulation (bleeding) disorder · have congestive heart failure · have fluid retention · have heart disease · have high blood pressure ******************************************************************* ADAPT Source: http://clinicaltrials.gov/show/NCT00007189
ADAPT Trial Exclusion Criteria:
History of peptic ulcer disease with bleeding or obstruction. Clinically significant liver or kidney disease. History of hypersensitivity to aspirin, ibuprofen, celecoxib, naproxen, or other NSAIDs. Use of anti-coagulant medication. Cognitive impairment or dementia. Current alcohol abuse or dependence ******************************************************************* My analysis of the info above....
Individuals that should not even take naproxin: CHF, heart disease and high BP
YET, these individuals were not even considered in those that should be excluded from the ADAPT trial. The only exclusion pertained to "anti-coagulant medication". Seems this trial was doomed from the onset.
Frankie
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