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FDA Medwatch Changes in Drug Warnings, etc.
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mainframetech  
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 More options Nov 16 2012, 9:34 am
Newsgroups: alt.support.kidney-disease, alt.support.diabetes
From: mainframetech <mainframet...@yahoo.com>
Date: Fri, 16 Nov 2012 06:34:22 -0800 (PST)
Local: Fri, Nov 16 2012 9:34 am
Subject: FDA Medwatch Changes in Drug Warnings, etc.
  If your drug is on the list, go to the link below and click on your
drug in the FDA list.

Good Luck,
Chris
=========

From: FDA MedWatch
Date: 11/15/2012
Subject: FDA MedWatch - October 2012 Safety Labeling Changes includes
58 products with revisions to Prescribing Information
The MedWatch October 2012 Safety Labeling Changes posting includes 58
products with safety labeling changes to the following sections:
CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and
PATIENT PACKAGE INSERT.
The "Summary Page" provides a listing of drug names and safety
labeling sections revised:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm326133.htm
The following drugs had modifications to the CONTRAINDICATIONS and/or
WARNINGS sections:

•     Aciphex (rabeprazole sodium)
•     Actemra (tocilizumab)
•     Advicor (niacin ER/lovastatin)
•     Alimta (pemetrexed for injection)
•     Altoprev (lovastatin)
•     Anafranil (clomipramine)
•     Avalide (irbesartan/hydrochlorothiazide)
•     Caduet (amlodipine/atorvastatin)
•     Cimzia (certolizumab pegol)
•     Clomid (clomiphene citrate)
•     Combigan (brimonidine tartrate/timolol maleate)
•     Crestor (rosuvastatin calcium)
•     Cymbalta (duloxetine hydrochloride)
•     Diovan (valsartan) and Diovan HCT (valsartan/
hydrochlorothiazide)
•     Edarbi (azilsartan medoxomil)
•     Edarbyclor (azilsartan medoxomil/chlorthalidone)
•     Fenoglide (fenofibrate)
•     Gelnique (oxybutynin chloride)
•     Juvisync (sitagliptin/simvastatin)
•     Lescol XL (fluvastatin sodium)
•     Letairis (ambrisentan)
•     Lipitor (atorvastatin calcium)
•     Livalo (pitavastatin)
•     Lotrel (amlodipine besylate and benazepril hydrochloride)
•     Mevacor (lovastatin)
•     Micardis (telmisartan) and Micardis HCT (telmisartan/
hydrochlorothiazide)
•     Nexium I.V. (esomeprazole sodium)
•     Nexium (esomeprazole magnesium)
•     Oxytrol (oxybutynin)
•     Pravachol (pravastatin sodium)
•     Prilosec (omeprazole)
•     Protonix (pantoprazole sodium)
•     Protonix I.V. (pantoprazole sodium)
•     Pamelor (nortriptyline HCl)
•     Remeron and Remeron SolTab (mirtazapine)
•     Simcor (Niacin ER/Simvastatin)
•     Tofranil-PM (imipramine pamoate)
•     Topamax (Topiramate)
•     Tracleer (Bosentan)
•     Twynsta (Telmisartan/Amlodipine)
•     Vimovo (naproxen/esomeprazole magnesium)
•     Vytorin (ezetimibe/simvastatin)
•     Zocor (simvastatin)


 
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Julie Bove  
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 More options Nov 16 2012, 11:22 am
Newsgroups: alt.support.kidney-disease, alt.support.diabetes
From: "Julie Bove" <julieb...@frontier.com>
Date: Fri, 16 Nov 2012 08:23:08 -0800
Local: Fri, Nov 16 2012 11:23 am
Subject: Re: FDA Medwatch Changes in Drug Warnings, etc.

Interesting!  I am not on any of those things now.  The proton pump
inhibitors all were nightmare drugs for me and I do mean literally, among
other things.  The Dr. who prescribed them for me did not prescribe for
short term use even though it clearly stated that in the prescribing
information.  When I started out, the longest I could take them was maybe
2-3 months before the troubles began.  But then the problems started coming
sooner.  At 2-3 weeks.  And then with the last one I tried, the effects were
pretty immediate.  It was as though my body was telling me...  Oh no!
You're not putting *that* crap in me again.  Are you?

The odd thing to me was that the Dr. just had me keep trying med after med
all of the same class.  As though he expected a different reaction to the
other ones.  But for me?  The same reaction to all of them.  My SIL had bad
reactions or simply no reaction to some of them and was able to find one
that worked for her.  And I know people who swear by the things.  However
one person who takes them has chronic migraines and refuses to listen to me
when I say that the meds caused migraines for me.  She just happily swallows
her pills and then takes other pills as well to try to knock out the
migraines!

Statins are the same way for me.  My body simpy does not like them and will
do bad things if I take them.


 
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Maya Zuiderweg  
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 More options Nov 16 2012, 11:31 am
Newsgroups: alt.support.kidney-disease, alt.support.diabetes
From: Maya Zuiderweg <$no_spam#ma_dot_zuiderweg_@_me_dot_com#maps_on$>
Date: Fri, 16 Nov 2012 17:31:35 +0100
Local: Fri, Nov 16 2012 11:31 am
Subject: Re: FDA Medwatch Changes in Drug Warnings, etc.
mainframetech stelde dit idée voor :

Thanks Chris. I'm happy to see that there are drugs that I am _not_ on
:-)
M.

 
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Jason  
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 More options Nov 16 2012, 2:46 pm
Newsgroups: alt.support.kidney-disease, alt.support.diabetes
From: Ja...@nospam.com (Jason)
Date: Fri, 16 Nov 2012 11:57:59 -0800
Local: Fri, Nov 16 2012 2:57 pm
Subject: Re: FDA Medwatch Changes in Drug Warnings, etc.
In article
<62900b5a-d0b4-4495-a50e-08eaa68df...@y8g2000yqy.googlegroups.com>,

Needless to say, the new contraindication warnings on statins do NOT shock
me. I found out from reading Doctor Sinatra's book that the long term use
of statins can even cause heart disease and cancer.

 
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mainframetech  
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 More options Nov 16 2012, 5:14 pm
Newsgroups: alt.support.kidney-disease, alt.support.diabetes
From: mainframetech <mainframet...@yahoo.com>
Date: Fri, 16 Nov 2012 14:14:49 -0800 (PST)
Local: Fri, Nov 16 2012 5:14 pm
Subject: Re: FDA Medwatch Changes in Drug Warnings, etc.
On Nov 16, 11:31 am, Maya Zuiderweg <

I'm happy to hear it...especially the statins, which among their large
list of side effects have added yet another one...:)

Chris


 
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Craig  
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 More options Nov 16 2012, 6:41 pm
Newsgroups: alt.support.kidney-disease, alt.support.diabetes
From: "Craig" <craigandb...@bigpond.com>
Date: Sat, 17 Nov 2012 10:41:39 +1100
Local: Fri, Nov 16 2012 6:41 pm
Subject: Re: FDA Medwatch Changes in Drug Warnings, etc.

"mainframetech" <mainframet...@yahoo.com> wrote in message

news:62900b5a-d0b4-4495-a50e-08eaa68df53b@y8g2000yqy.googlegroups.com...
  If your drug is on the list, go to the link below and click on your
drug in the FDA list.

Good Luck,
Chris
=========

From: FDA MedWatch
Date: 11/15/2012
Subject: FDA MedWatch - October 2012 Safety Labeling Changes includes
58 products with revisions to Prescribing Information
The MedWatch October 2012 Safety Labeling Changes posting includes 58
products with safety labeling changes to the following sections:
CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and
PATIENT PACKAGE INSERT.
The "Summary Page" provides a listing of drug names and safety
labeling sections revised:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm326133.htm
The following drugs had modifications to the CONTRAINDICATIONS and/or
WARNINGS sections:

• Aciphex (rabeprazole sodium)
• Actemra (tocilizumab)
• Advicor (niacin ER/lovastatin)
• Alimta (pemetrexed for injection)
• Altoprev (lovastatin)
• Anafranil (clomipramine)
• Avalide (irbesartan/hydrochlorothiazide)
• Caduet (amlodipine/atorvastatin)
• Cimzia (certolizumab pegol)
• Clomid (clomiphene citrate)
• Combigan (brimonidine tartrate/timolol maleate)
• Crestor (rosuvastatin calcium)
• Cymbalta (duloxetine hydrochloride)
• Diovan (valsartan) and Diovan HCT (valsartan/
hydrochlorothiazide)
• Edarbi (azilsartan medoxomil)
• Edarbyclor (azilsartan medoxomil/chlorthalidone)
• Fenoglide (fenofibrate)
• Gelnique (oxybutynin chloride)
• Juvisync (sitagliptin/simvastatin)
• Lescol XL (fluvastatin sodium)
• Letairis (ambrisentan)
• Lipitor (atorvastatin calcium)
• Livalo (pitavastatin)
• Lotrel (amlodipine besylate and benazepril hydrochloride)
• Mevacor (lovastatin)
• Micardis (telmisartan) and Micardis HCT (telmisartan/
hydrochlorothiazide)
• Nexium I.V. (esomeprazole sodium)
• Nexium (esomeprazole magnesium)
• Oxytrol (oxybutynin)
• Pravachol (pravastatin sodium)
• Prilosec (omeprazole)
• Protonix (pantoprazole sodium)
• Protonix I.V. (pantoprazole sodium)
• Pamelor (nortriptyline HCl)
• Remeron and Remeron SolTab (mirtazapine)
• Simcor (Niacin ER/Simvastatin)
• Tofranil-PM (imipramine pamoate)
• Topamax (Topiramate)
• Tracleer (Bosentan)
• Twynsta (Telmisartan/Amlodipine)
• Vimovo (naproxen/esomeprazole magnesium)
• Vytorin (ezetimibe/simvastatin)
• Zocor (simvastatin)

Thanks again for  your regular updates with these lists. There is one there
I take, (januvia) I think the benefits seem to outweigh the side effects for
now.
Craig


 
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Maya Zuiderweg  
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 More options Nov 16 2012, 6:47 pm
Newsgroups: alt.support.kidney-disease, alt.support.diabetes
From: Maya Zuiderweg <$no_spam#ma_dot_zuiderweg_@_me_dot_com#maps_on$>
Date: Sat, 17 Nov 2012 00:47:49 +0100
Local: Fri, Nov 16 2012 6:47 pm
Subject: Re: FDA Medwatch Changes in Drug Warnings, etc.
Craig schreef :

I dont see Januvia in that list.
M.

 
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Craig  
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 More options Nov 16 2012, 7:26 pm
Newsgroups: alt.support.kidney-disease, alt.support.diabetes
From: "Craig" <craigandb...@bigpond.com>
Date: Sat, 17 Nov 2012 11:25:49 +1100
Local: Fri, Nov 16 2012 7:25 pm
Subject: Re: FDA Medwatch Changes in Drug Warnings, etc.

"Maya Zuiderweg" <$no_spam#ma_dot_zuiderweg_@_me_dot_com#maps_on$> wrote in
message news:db-dnV7Mr884TTvNnZ2dnUVZ7sOdnZ2d@giganews.com...

Hi Maya,
It's  in some of the combo drugs there ( Juvisync) and if you click on the
link its listed there on its own also.

Best Wishes,
Craig


 
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Maya Zuiderweg  
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 More options Nov 16 2012, 7:45 pm
Newsgroups: alt.support.kidney-disease, alt.support.diabetes
From: Maya Zuiderweg <$no_spam#ma_dot_zuiderweg_@_me_dot_com#maps_on$>
Date: Sat, 17 Nov 2012 01:45:21 +0100
Local: Fri, Nov 16 2012 7:45 pm
Subject: Re: FDA Medwatch Changes in Drug Warnings, etc.
Craig formuleerde de vraag :

Okay, thanks Craig :-)
M.

 
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mainframetech  
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 More options Nov 16 2012, 8:35 pm
Newsgroups: alt.support.kidney-disease, alt.support.diabetes
From: mainframetech <mainframet...@yahoo.com>
Date: Fri, 16 Nov 2012 17:35:16 -0800 (PST)
Local: Fri, Nov 16 2012 8:35 pm
Subject: Re: FDA Medwatch Changes in Drug Warnings, etc.
On Nov 16, 6:41 pm, "Craig" <craigandb...@bigpond.com> wrote:

 Yep.  Sometimes it's a tough decision.  Taking some medications can
do permanent harm, but confer benefit.

Good Luck,
Chris


 
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mainframetech  
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 More options Nov 16 2012, 8:36 pm
Newsgroups: alt.support.kidney-disease, alt.support.diabetes
From: mainframetech <mainframet...@yahoo.com>
Date: Fri, 16 Nov 2012 17:36:37 -0800 (PST)
Local: Fri, Nov 16 2012 8:36 pm
Subject: Re: FDA Medwatch Changes in Drug Warnings, etc.
On Nov 16, 7:45 pm, Maya Zuiderweg <

  Yes, that's a good point.  Sometimes the FDA list is more complete
than the email version I get.  Going to the link on the post should
get you to the complete list.

Chris


 
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Craig  
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 More options Nov 16 2012, 10:00 pm
Newsgroups: alt.support.kidney-disease, alt.support.diabetes
From: "Craig" <craigandb...@bigpond.com>
Date: Sat, 17 Nov 2012 13:59:49 +1100
Local: Fri, Nov 16 2012 9:59 pm
Subject: Re: FDA Medwatch Changes in Drug Warnings, etc.

"mainframetech" <mainframet...@yahoo.com> wrote in message

news:1bcf7b15-250c-49f8-9e6b-ec568152de07@b6g2000yqd.googlegroups.com...
On Nov 16, 6:41 pm, "Craig" <craigandb...@bigpond.com> wrote:

 Yep.  Sometimes it's a tough decision.  Taking some medications can
do permanent harm, but confer benefit.

Good Luck,
Chris

I tried stopping januvia for a while ( about a week) and felt like crap.
Your own example of having to find your own way through the maze, to get to
what works for you  is illustrative of the tough decisions we must make in
our quest for continuing health.

Hope you are doing well.
Take care.
Craig


 
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Don Roberto  
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 More options Nov 17 2012, 2:58 am
Newsgroups: alt.support.kidney-disease, alt.support.diabetes
From: Don Roberto <anothascreen...@aol.com>
Date: Fri, 16 Nov 2012 23:58:00 -0800
Subject: Re: FDA Medwatch Changes in Drug Warnings, etc.
On 11/16/2012 4:25 PM, Craig wrote:

yeah. Chris always leaves out a couple just to check how sharp y'all are


 
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Don Roberto  
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 More options Nov 17 2012, 3:00 am
Newsgroups: alt.support.kidney-disease, alt.support.diabetes
From: Don Roberto <anothascreen...@aol.com>
Date: Fri, 16 Nov 2012 23:59:58 -0800
Local: Sat, Nov 17 2012 2:59 am
Subject: Re: FDA Medwatch Changes in Drug Warnings, etc.
On 11/16/2012 5:36 PM, mainframetech wrote:

Always putting the blame somewhere else...
But you can't fool
Don Roberto

Going to the link on the post should


 
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Julie Bove  
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 More options Nov 17 2012, 5:46 am
Newsgroups: alt.support.kidney-disease, alt.support.diabetes
From: "Julie Bove" <julieb...@frontier.com>
Date: Sat, 17 Nov 2012 02:46:28 -0800
Local: Sat, Nov 17 2012 5:46 am
Subject: Re: FDA Medwatch Changes in Drug Warnings, etc.

"Maya Zuiderweg" <$no_spam#ma_dot_zuiderweg_@_me_dot_com#maps_on$> wrote in
message news:db-dnV7Mr884TTvNnZ2dnUVZ7sOdnZ2d@giganews.com...

It's listed on the actual list.

 
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