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Summary View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- December 2007

 

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
Carbatrol (carbamazepine) Extended-Release Capsules X
 
X
X
 
 
Equetro (carbamazepine) Extended-Release Capsules
X
 
X
X
X
 
Omniscan (gadodiamide) Injection for Intravenous Use
X
 
X
X
 
 

Tegretol (carbamazepine) USP, Chewable Tablets, and Oral Suspension

Tegretol-XR (carbamazepine extended-release tablets)

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

BW

C

W

P

AR

PPI/MG
Ambien CR (zolpidem tartrate extended-release) Tablets   X X X
 
MG
AndroGel (testosterone gel) 1%  

X

X X
X
PPI
Dostinex (cabergoline) Tablets   X X X
X
 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG

Aredia (pamidronate disodium for injection)

    X X
X
 

Biaxin Filmtab (clarithromycin tablets, USP)

Biaxin XL Filmtab (clarithromycin extended-release tablets)

Biaxin Granules (clarithromycin for oral suspension, USP)

    X X
 
 
DepoDur (morphine sulfate extended-release liposome injection)     X  
X
 
Derma-Smoothe/FS (fluocinolone acetonide) Topical Oil 0.01% (Body Oil)     X X
X
 
Doryx (doxycycline hyclate) Capsule, Delayed Release Pellets     X X
 
 
Effexor XR (venlafaxine hydrochloride) Extended-Release Capsules     X X
X
 
Exjade (deferasirox) Tablets for Oral Suspension     X   X  
Heparin Sodium Injection, USP     X      
Heparin Sodium Injection, USP (porcine) 5,000 U/mL     X X X  
Hepsera (adefovir dipivoxil) Tablets     X X X  
Invega (paliperidone) Extended-Release Tablets     X X    

Levaquin (levofloxacin) Tablets and Oral Solution

Levaquin (levofloxacin) Injection, for Intravenous Use

Levaquin (levofloxacin in 5% dextrose) Injection, for Intravenous Use

    X X X  
Monodox (doxycycline monohydrate) Capsules     X X    
Sonata (zaleplon) Capsules     X X   MG
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG

Atrovent (ipratropium bromide) Nasal Spray 0.03%, 21 mcg/spray

      X
 
 
Brovana (arformoterol tartrate) Solution       X
 
MG

CellCept (mycophenolate mofetil capsules and tablets)

CellCept Oral Suspension (mycophenolate mofetil for oral suspension)

CellCept Intravenous (mycophenolate mofetil hydrochloride for injection)

      X
 
 
Factive (gemifloxacin) Tablets       X
X
 
Floxin (ofloxacin) Tablets       X
X
PPI
INOmax (nitric oxide) for Inhalation       X
 
 
Lexiva (fosamprenavir calcium) Tablets and Oral Suspension       X
 
 

Malarone (atovaquone and proguanil hydrochloride) Tablets

Malarone (atovaquone and proguanil hydrochloride) Pediatric Tablets

      X
X
 

Protonix I.V. (pantoprazole sodium) for Injection

      X
 
 

Protonix (pantoprazole sodium) Delayed-Release Tablets

Protonix (pantoprazole sodium) for Delayed-Release Oral Suspension

      X    
Ranexa (ranolazine) Extended-Release Tablets       X
 
 
Rebetol (ribavirin, USP) Capsules and Oral Solution       X
 
MG
Revatio (sildenafil citrate) Tablets       X
X
PPI
Reyataz (atazanavir) Capsules       X
 
 
Thyrogen (thyrotropin alfa for injection)       X
X
 
Tirosint (levothyroxine sodium) Capsules       X
 
 
Venofer (iron sucrose injection, USP)       X
X
 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG

Fludara (fludarabine phosphate) for Injection

       
X
 
Valtrex (valacyclovir hydrochloride) Caplets        
X
 
Vytorin (ezetimibe/simvastatin tablets)        
X
PPI
Zetia (ezetimibe) Tablets        
X
PPI
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Gonal-f RFF Pen (follitropin alfa injection)
 
 
 
 
 
  PPI

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