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U.S. Department of Health and Human Services

Safety

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January 2008

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

EstroGel 0.06% (estradiol gel) X  
X
X
X
PPI
Herceptin (trastuzumab) Intravenous Infusion X   X X X  
Rituxan (rituximab) Injection For Intravenous Use
X
 
X
X
X
MG

(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG

Alesse 28 Tablets (levonorgestrel and ethinyl estradiol tablets)   X X     PPI
Janumet (sitagliptin/metformin HCl) Tablets   X X X
X
PPI
Mycamine (micafungin sodium) For Injection   X   X
X
 
Omnitrope [somatropin (rDNA origin) injection] For Subcutaneous Use   X X X
X
PPI
Tysabri (natalizumab) Injection For Intravenous Use   X X X X MG
WelChol (colesevelam hydrochloride) Tablets   X X X X  

(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG

Azactam (aztreonam for injection, USP)     X X    
Azactam (aztreonam injection) in GALAXY Plastic Container (PL 2040) For Intravenous Use     X X    
Chantix (varenicline) Tablets     X X    
Cialis (tadalafil) Tablets     X X   PPI
E.E.S. (erythromycin ethylsuccinate)     X X    
Ery-Ped (erythromycin ethylsuccinate, USP)     X X    
Humira (adalimumab) Injection, Solution For Subcutaneous Use     X X   MG
Lunesta (eszopiclone) Tablets     X X   MG
Ortho Evra (norelgestromin/ethinyl estradiol transdermal system)     X     PPI
PCE (erythromycin particles in tablets) Dispertab Tablets     X X    
Rapamune (sirolimus) Oral Solution and Tablets     X X X  

(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG

Byetta (exenatide) injection       X   PPI
Cipro I.V. (ciprofloxacin) For Intravenous Infusion       X
X
 

Cipro (ciprofloxacin hydrochloride) Tablets

Cipro (ciprofloxacin) Oral Suspension

      X
X
PPI
Cipro XR (ciprofloxacin extended-release tablets)       X
X
PPI
Effexor (venlafaxine hydrochloride) Tablets       X    
Effexor XR (venlafaxine hydrochloride) Extended-Release Capsules       X    
Flumadine (rimantadine) Tablets and Syrup       X    
Inderide (propranolol hydrochloride [Inderal] and hydrochlorothiazide) Tablets       X    
InnoPran XL (propranolol hydrochloride) Extended Release Capsules       X    

Lopressor (metoprolol tartrate tablets, USP)

Lopressor (metoprolol tartrate injection, USP)

      X    
Lopressor HCT (metoprolol tartrate USP and hydrochlorothiazide USP) Tablets       X    
Seroquel (quetiapine fumarate) Tablets       X
X
 
Sular (nisoldipine) Extended Release Tablets       X
X
 
Tamiflu (oseltamivir phosphate) Capsules and For Oral Suspension       X
X
PPI
Triglide (fenofibrate) Tablets       X    

(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG

Celebrex (celecoxib) Capsules        
X
 
Climara (estradiol transdermal system)        
X
 
Lotrisone (clotrimazole and betamethasone dipropionate) Cream and Lotion        
X
PPI

(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG

Avandia (rosiglitazone maleate) Tablets           PPI

Nexium (esomeprazole magnesium) Delayed-Release Capsules

Nexium (esomeprazole magnesium) Delayed-Release Oral Suspension

         
PPI

Tolectin DS (tolmetin sodium) Capsules

Tolectin 600 (tolmetin sodium) Tablets For Oral Administration

         
MG