Google Groups no longer supports new Usenet posts or subscriptions. Historical content remains viewable.
Dismiss

FDA Medwatch Changes in Drug Warnings, etc.

36 views
Skip to first unread message

mainframetech

unread,
Nov 16, 2012, 9:34:22 AM11/16/12
to
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)

Julie Bove

unread,
Nov 16, 2012, 11:23:08 AM11/16/12
to
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.


Maya Zuiderweg

unread,
Nov 16, 2012, 11:31:35 AM11/16/12
to
mainframetech stelde dit idée voor :
Thanks Chris. I'm happy to see that there are drugs that I am _not_ on
:-)
M.


Jason

unread,
Nov 16, 2012, 2:57:59 PM11/16/12
to
In article
<62900b5a-d0b4-4495...@y8g2000yqy.googlegroups.com>,
mainframetech <mainfr...@yahoo.com> wrote:

> If your drug is on the list, go to the link below and click on your
> drug in the FDA list.
>
> Good Luck,
> Chris
> =3D=3D=3D=3D=3D=3D=3D=3D=3D
>
> 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:
>
> =95 Aciphex (rabeprazole sodium)
> =95 Actemra (tocilizumab)
> =95 Advicor (niacin ER/lovastatin)
> =95 Alimta (pemetrexed for injection)
> =95 Altoprev (lovastatin)
> =95 Anafranil (clomipramine)
> =95 Avalide (irbesartan/hydrochlorothiazide)
> =95 Caduet (amlodipine/atorvastatin)
> =95 Cimzia (certolizumab pegol)
> =95 Clomid (clomiphene citrate)
> =95 Combigan (brimonidine tartrate/timolol maleate)
> =95 Crestor (rosuvastatin calcium)
> =95 Cymbalta (duloxetine hydrochloride)
> =95 Diovan (valsartan) and Diovan HCT (valsartan/
> hydrochlorothiazide)
> =95 Edarbi (azilsartan medoxomil)
> =95 Edarbyclor (azilsartan medoxomil/chlorthalidone)
> =95 Fenoglide (fenofibrate)
> =95 Gelnique (oxybutynin chloride)
> =95 Juvisync (sitagliptin/simvastatin)
> =95 Lescol XL (fluvastatin sodium)
> =95 Letairis (ambrisentan)
> =95 Lipitor (atorvastatin calcium)
> =95 Livalo (pitavastatin)
> =95 Lotrel (amlodipine besylate and benazepril hydrochloride)
> =95 Mevacor (lovastatin)
> =95 Micardis (telmisartan) and Micardis HCT (telmisartan/
> hydrochlorothiazide)
> =95 Nexium I.V. (esomeprazole sodium)
> =95 Nexium (esomeprazole magnesium)
> =95 Oxytrol (oxybutynin)
> =95 Pravachol (pravastatin sodium)
> =95 Prilosec (omeprazole)
> =95 Protonix (pantoprazole sodium)
> =95 Protonix I.V. (pantoprazole sodium)
> =95 Pamelor (nortriptyline HCl)
> =95 Remeron and Remeron SolTab (mirtazapine)
> =95 Simcor (Niacin ER/Simvastatin)
> =95 Tofranil-PM (imipramine pamoate)
> =95 Topamax (Topiramate)
> =95 Tracleer (Bosentan)
> =95 Twynsta (Telmisartan/Amlodipine)
> =95 Vimovo (naproxen/esomeprazole magnesium)
> =95 Vytorin (ezetimibe/simvastatin)
> =95 Zocor (simvastatin)

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.


mainframetech

unread,
Nov 16, 2012, 5:14:49 PM11/16/12
to
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

Craig

unread,
Nov 16, 2012, 6:41:39 PM11/16/12
to

"mainframetech" <mainfr...@yahoo.com> wrote in message
news:62900b5a-d0b4-4495...@y8g2000yqy.googlegroups.com...
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


Maya Zuiderweg

unread,
Nov 16, 2012, 6:47:49 PM11/16/12
to
Craig schreef :
I dont see Januvia in that list.
M.


Craig

unread,
Nov 16, 2012, 7:25:49 PM11/16/12
to

"Maya Zuiderweg" <$no_spam#ma_dot_zuiderweg_@_me_dot_com#maps_on$> wrote in
message news:db-dnV7Mr884TTvN...@giganews.com...
> Craig schreef :
>> "mainframetech" <mainfr...@yahoo.com> wrote in message
>> news:62900b5a-d0b4-4495...@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
>
> I dont see Januvia in that list.
> M.

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
>
>


Maya Zuiderweg

unread,
Nov 16, 2012, 7:45:21 PM11/16/12
to
Craig formuleerde de vraag :
Okay, thanks Craig :-)
M.


mainframetech

unread,
Nov 16, 2012, 8:35:16 PM11/16/12
to
On Nov 16, 6:41 pm, "Craig" <craigandb...@bigpond.com> wrote:
> "mainframetech" <mainframet...@yahoo.com> wrote in message
Yep. Sometimes it's a tough decision. Taking some medications can
do permanent harm, but confer benefit.

Good Luck,
Chris

mainframetech

unread,
Nov 16, 2012, 8:36:37 PM11/16/12
to
On Nov 16, 7:45 pm, Maya Zuiderweg <
$no_spam#ma_dot_zuiderweg_@_me_dot_com#maps_on$> wrote:
> Craig formuleerde de vraag :
>
>
>
>
>
> > "Maya Zuiderweg" <$no_spam#ma_dot_zuiderweg_@_me_dot_com#maps_on$> wrote in
> > messagenews:db-dnV7Mr884TTvN...@giganews.com...
> >> Craig schreef :
> >>> "mainframetech" <mainframet...@yahoo.com> wrote in message
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

Craig

unread,
Nov 16, 2012, 9:59:49 PM11/16/12
to

"mainframetech" <mainfr...@yahoo.com> wrote in message
news:1bcf7b15-250c-49f8...@b6g2000yqd.googlegroups.com...
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


Don Roberto

unread,
Nov 17, 2012, 2:58:00 AM11/17/12
to
yeah. Chris always leaves out a couple just to check how sharp y'all are

> Best Wishes,
> Craig
>>
>>
>
>

Don Roberto

unread,
Nov 17, 2012, 2:59:58 AM11/17/12
to
Always putting the blame somewhere else...
But you can't fool
Don Roberto

Julie Bove

unread,
Nov 17, 2012, 5:46:28 AM11/17/12
to

"Maya Zuiderweg" <$no_spam#ma_dot_zuiderweg_@_me_dot_com#maps_on$> wrote in
message news:db-dnV7Mr884TTvN...@giganews.com...
> Craig schreef :
>> "mainframetech" <mainfr...@yahoo.com> wrote in message
>> news:62900b5a-d0b4-4495...@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
>
> I dont see Januvia in that list.
> M.

It's listed on the actual list.


0 new messages