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Summary View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- February 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
Actiq (fentanyl citrate) Oral Transmucosal Lozenge X
X
X
X
X
 
Femring (estradiol acetate vaginal ring)
X
   
X
X
X
PPI
Humira (adalimumab) Solution for Subcutaneous Injection
X
   
X
X
X
PPI
Ketek (telithromycin) Tablets
X
X
X
X
X MG
Lotensin (benazepril hydrochloride) Tablets
X
 
X
X
   
Lotensin HCT (benazepril hydrochloride and hydrochlorothiazide, USP) Combination Tablets
X
 
X
X
   
Lotrel (amlodipine besylate and benazepril hydrochloride)
X
 
X
X
   
Rituxan (rituximab)
X
X
    X PPI
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Diprivan (propofol) Injectable Emulsion for IV Administration   X X X
 
 
Nardil (phenelzine sulfate tablets, USP)  

X

  X
   
 
Norditropin Cartridges (somatropin [rDNA origin] injection)   X   X
 
 
Nutropin (somatropin [rDNA origin] for injection)   X   X    
Nutropin AQ (somatropin [rDNA origin] injection)   X   X    
Tev-Tropin (somatropin [rDNA origin] for injection)   X   X
X
 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Actos (pioglitazone hydrochloride) Tablets     X X
X
 
Cymbalta (duloxetine hydrochloride) Delayed-release Capsules     X X
X
 
DepoDur (morphine sulfate extended-release liposome injection)     X  
X
 
Extraneal (icodextrin) Peritoneal Dialysis Solution     X X
 
PPI
Pravachol (pravastatin sodium) Tablets     X  
X
 
Prinivil (lisinopril) Tablets     X X
 
 
Prinzide (lisinopril-hydrochlorothiazide) Tablets     X X
 
 
Sutent (sunitinib malate) Capsules     X X
X
PPI
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Bentyl (dicyclomine hydrochloride, USP) Capsules, Tablets, Syrup, and Injection       X
 
 
Boniva (ibandronate sodium) Tablets       X
 
PPI
Duetact (pioglitazone hydrochloride and glimepiride) Tablets       X
X
PPI
Effexor (venlafaxine hydrochloride) Tablets        X
 
 
Effexor XR (venlafaxine hydrochloride) Extended Release Capsules       X
 
 
Flomax (tamsulosin hydrochloride) Capsules       X
 
PPI
Fortical (calcitonin-salmon [rDNA origin]) Nasal Spray       X
 
 
Inderal (propranolol hydrochloride) Tablets       X
 
 
Inderal LA (propranolol hydrochloride) Long-Acting Capsules       X
 
 
Inderide (propranolol hydrochloride and hydrochlorothiazide)       X
 
 
Lexiva (fosamprenavir calcium) Tablets       X
 
 
Peganone (ethotoin tablets, USP)       X
 
 
Tracleer (bosentan) Film Coated Tablets       X
 
MG
Vaprisol (conivapatan hydrochloride injection)       X
X
 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Abraxane for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) [albumin-bound]        
X
 
Baraclude (entecavir) Tablets and Oral Solution        
X
 
Cubicin (daptomycin for injection)        
X
 
Dostinex (cabergoline tablets)        
X
 
Micardis (telmisartan) Tablets        
X
 
Micardis HCT (telmisartan and hydrochlorothiazide) Tablets        
X
 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Boniva (ibandronate sodium) Injection
 
 
 
 
 
PPI
Pulmicort Flexhaler (budesonide inhalation powder) for Oral Inhalation Only
 
 
 
 
 
PPI
Omacor (omega-3-acid ethyl esters) Capsules
 
 
 
 
 
PPI
Vyvanse (lisdexamfetamine dimesylate)
 
 
 
 
 
MG

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