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U.S. Department of Health and Human Services

Safety

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January 2014

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
Cozaar (losartan) 25 mg, 50 mg, and 100 mg Tablets 
X
 XX PPI 
Hyzaar (losartan/hydrochlorothiazide) 50/12.5 mg, 100/12.5 mg, and 100/25 mg Tablets 
X
 XX PPI 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Lidocaine Hydrochloride (4% and 8%) and Dextrose 5% Injection  XXXX 
Victrelis (boceprevir), 200 mg capsules X X MG
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Cerebyx (fosphenytoin)   XX  
Doribax (doripenem) for Injection   XX  
FeverAll (acetaminophen) 80 mg, 120 mg, 325 mg, and 650 mg Suppositories   X   
Multaq (dronedarone hydrochloride) 400 mg Tablets  XX  
Revatio 20 mg Tablets
Revatio 10 mg/12.5 mL for Injection
Revatio 10 mg/mL Powder for Oral suspension

 
  XX PPI
Topamax (topiramate) Tablets (25mg, 50mg, 100mg, and 200mg)
Topamax (topiramate) Sprinkle Capsules (15mg, and 25mg)
  XX  
Vidaza (azacitidine) for Injection  XX  
Xarelto (Rivaroxaban) Tablets, 10 mg  X   
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Accuretic (quinapril/hydrochlorothiazide) 10/12.5 mg, 20/12.5 mg, and 20/25 mg Tablets    XX 
Aldactazide (spironolctone/hydrochlorothiazide) 25/25 mg, and 50/50 mg Tablets    XX 
Dilantin - 125 (phenytoin) Oral Suspension
Dilantin (phenytoin) Injection
 
   XX 
Eliquis (apixaban) 2.5 and 5 mg Tablets    X  
Tegretol (carbamazepine) Chewable Tablets, Tegretol (carbamazepine) Oral Suspension
Tegretol-XR (carbamazepine extended-release) Tablets 
   X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Cordarone (amiodarone HCl) Tablets     
X
 
Propecia (finasteride) Tablet, 1 mg     
X
PPI
Viramune (nevirapine) tablets and oral suspension    X 
Viramune XR (nevirapine) extended-release tablets    X 
Zyvox (linezolid) Oral Tablets, 400 mg and 600 mg
Zyvox (linezolid) IV Injection, 2 mg/mL
Zyvox (linezolid) for Oral Suspension, 100 mg/5mL
    X 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Letairis (ambrisentan) 5 mg and 10 mg Tablets      MG