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U.S. Department of Health and Human Services

Safety

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November 2011

Drug 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
Cerebyx (fosphenytoin sodium) InjectionXXXX  
Dilantin (phenytoin sodium, USP) Injection 
X
 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Dilantin (phenytoin) Oral Suspension XXXX 
Kombiglyze XR (saxagliptin/metformin hydrochloride extended-release) Tablets XPCI 
Mytelase (ambenonium chloride) Tablets X XX 
Onglyza (saxagliptin) Tablets XXXXPCI
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG

Amturnide (aliskiren/amlodipine/hydrochlorothiazide) Tablets 

*Amlodipine/Simvsatin Interaction

  XX  

Combivir (lamivudine/zidovudine) Tablets

*Immune Reconstitution Syndrome 

  XX  

Emtriva (emtricitabine) Capsules and Oral Solution

*Immune Reconstitution Syndrome 

  XX  

Epivir (lamivudine) Tablets and Oral Solution

*Immune Reconstitution Syndrome

  XX  

Epzicom (abacavir sulfate and lamivudine) Tablets

*Immune Reconstitution Syndrome

  XX  
Isentress (raltegravir potassium) Tablets  XXX 
Lioresal Intrathecal (baclofen injection)  XX  
Methotrexate Sodium for Injection  X   

Retrovir (zidovudine) IV Infusion, Capsules, Tablets, and Syrup

*Immune Reconstitution Syndrome

  XX  

Tekamlo (aliskiren/amlodipine) Tablets 

*Amlodipine/Simvsatin Interaction

  XX  
Toviaz (fesoterodine fumarate) Extended Release Tablets  XX  

Tribenzor (olmesartan medoxomil, amlodipine, hydrochlorothiazide) Tablets 

*Amlodipine/Simvsatin Interaction

  XX  

Trizivir (abacavir sulfate, lamivudine, and zidovudine) Tablets

*Immune Reconstitution Syndrome

  XX  

Twynsta (telmisartan/amlodipine)

*Amlodipine/Simvsatin Interaction

  XX  
VFEND (voriconazole) Tablets, I.V. for Infusion and Oral Suspension  XXX 

Videx (didanosine) Pediatric Powder Oral Solution

*Immune Reconstitution Syndrome

  XX  

Videx EC (didanosine, USP) Capsules

*Immune Reconstitution Syndrome

  XX  
Vimovo (naproxen/esomeprazole magnesium) Tablets  XXX 

Viread (tenofovir disoproxil fumarate) Tablets

*Immune Reconstitution Syndrome

  XX  

Zerit (stavudine) Capsules and Oral Solution

*Immune Reconstitution Syndrome

  XX  

Ziagen (abacavir sulfate) Tablets and Oral Solution

*Immune Reconstitution Syndrome

  XX  
Zyflo CR (zileuton) Extended Release Tablets  XX  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Agrylin (anagrelide hydrochloride) Capsule   X  
Amoxil (amoxicillin) Chewable Tablets, Tablets and Oral Suspension    X  

Calan (verapamil hydrochloride) Intravenous Injection and Calan (verapamil hydrochloride) Intravenous Injection Syringe

*Verapamil/HMG-CoA Reductase Inhibitors Interaction

   X  
Cordarone (amiodarone HCl) Tablets   X  

Covera HS (verapamil hydrochloride) Extended Release Tablets

*Verapamil/HMG-CoA Reductase Inhibitors Interaction

   X  
Cozaar (losartan) Tablets    X PPI 
Hyzaar (losartan/hydrochlorothiazide) Tablets    X PPI 
Prinivil (lisinopril) Tablets    X PPI 
Prinzide (lisinopril/hydrochlorothiazide) Tablets    X PPI 
Protopic (tacrolimus) Ointment   XX 

Tarka (trandolapril/verapamil hydrochloride) Tablets

*Verapamil/HMG-CoA Reductase Inhibitors Interaction

   X  
Treximet (sumatriptan/naproxen) Tablets    X  

Verelan PM (verapamil hydrochloride) Extended-Release Capsules
Verelan (verapamil hydrochloride) Sustained-Release Capsules
 

*Verapamil/HMG-CoA Reductase Inhibitors Interaction

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

BW

C

W

P

AR

PPI/MG
Lamisil (terbinafine hydrochloride) Tablets and Oral Granules    XPCI
Tasigna (nilotinib) Capsules
 
    X 
Velcade (bortezomib) for Injection     
X
 
Viramune (nevirapine) Tablets, Oral Suspension and Virammune XR Extended-Release Tablets    X 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
AndroGel (testosterone gel)      MG
Lamictal (lamotrigine) Tablets, Chewable Dispersible Tablets, Orally Disintegrating Tablets, and Lamictal XR (lamotrigine) Extended-Release Tablets     MG
Testim (testosterone gel)
 
     MG