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U.S. Department of Health and Human Services

Safety

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May 2011

Safety Labeling Changes

 

The summary view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. The “quick view” table below provides the drug name and sections modified. Click on the drug name to go to the detailed view. The detailed view includes sections and subsections modified, a description of new or modified safety information in the BOXED WARNING, CONTRAINDICATIONS, or WARNINGS sections, and a link to the revised prescribing information.

Key to Label Section Acronyms:

BW=BOXED WARNING, C=CONTRAINDICATIONS, W=WARNINGS, P=PRECAUTIONS, AR=ADVERSE REACTIONS, PPI/MG=PATIENT PACKAGE INSERT/MEDICATION GUIDE

 
     
DRUG NAME
SECTIONS MODIFIED
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Imuran (azathioprine) Tablets and Injection
X
 X X 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Biaxin Filmtab (clarithromycin tablets, USP)
Biaxin XL Filmtab (clarithromycin extended-release tablets)
Biaxin Granules (clarithromycin for oral suspension, USP)
 XX X 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG

Aciphex (rabeprazole sodium) Delayed-Release Tablets

* Proton Pump Inhibitors Class Label Change

  XXXX
Afinitor (everolimus) Tablets  XX  
Aldactazide (spironolactone/hydrochlorothiazide) Tablets  X   
Avandia (rosiglitazone maleate)
Avandamet (rosiglitazone maleate/metformin hydrochloride)
Avandaryl (rosiglitazone maleate/glimepiride) Tablets
  XX  
Benicar HCT (olmesartan medoxomil/hydrochlorothiazide) Tablets   X   

Dexilant (dexlansoprazole) Delayed Release Capsules

* Proton Pump Inhibitors Class Label Change

  XXXX
Genotropin (somatropin [rDNA origin] for Injection  XXX 
Humalog (insulin lispro [rDNA origin]) Injection  XX  
Levatol (penbutolol sulfate) Tablets  XX  
Micardis HCT (telmisartan/hydrochlorothiazide) Tablets   X  
Norditropin Cartridges (somatropin [rDNA origin] injection)   XXX 

Omeprazole / Sodium Bicarbonate / Magnesium Hydroxide Tablets

* Proton Pump Inhibitors Class Label Change

  XXXX
Purinethol (mercaptopurine) Tablets  X   

Prevacid (Lansoprazole) Delayed-Release Capsules, Prevacid SoluTab  Delayed-Release Orally Disintegrating Tablets

* Proton Pump Inhibitors Class Label Change

  XXXX

Prilosec (omeprazole) Delayed Release Capsules and Prilosec For Delayed Release Oral Suspension

* Proton Pump Inhibitors Class Label Change

  XXXX

Proton Pump Inhibitors

* Proton Pump Inhibitors Class Label Change

  XXXX

Protonix (pantoprazole sodium) For Delayed-Release Oral Suspension ; Delayed-Release Tablets, and I.V. for Injection

* Proton Pump Inhibitors Class Label Change

  X XXX

Seroquel (quetiapine fumarate) Tablets

Seroquel XR (quetiapine fumarate) Extended-Release

  XX  
Sutent (sunitinib malate) Capsules  XXX 
Teveten HCT (eprosartan mesylate/hydrochlorothiazide) Tablets   XX  
Uniretic (moexipril hydrochloride/hydrochlorothiazide)  X   

Vimovo (naproxen/esomeprazole magnesium) Tablets

* Proton Pump Inhibitors Class Label Change

  XXXX

Zegerid (omeprazole/sodium bicarbonate) Capsules and Powder for Oral Suspension

* Proton Pump Inhibitors Class Label Change

  XXXX
Ziac (bisoprolol fumarate/hydrochlorothiazide) Tablets  X   
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Azor (amlodipine and olmesartan medoxomil) Tablets   XX 
Capoten (captopril) Tablets   X  
Exforge (amlodipine/valsartan) Tablets    X  
Lexiva (fosamprenavir calcium) Tablets and Oral Suspension    X  
Teveten (eprosartan mesylate) Tablets    X  
Valturna (aliskiren/valsartan) Tablets   X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Benicar (olmesartan medoxomil) Tablets     
X
 

Vibramycin (doxycycline monohydrate) Oral Suspension

Vibramycin (doxycycline hyclate) Capsules

Vibramycin (doxycycline calcium oral suspension) Syrup

Vibra-Tabs (doxycycline hyclate) 

    
X
 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Foradil Aerolizer (formoterol fumarate inhalation powder)      MG