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U.S. Department of Health and Human Services

Safety

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February 2010

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
Caduet (amlodipine besylate/atorvastatin calcium) tablets   X X X X  
Cialis (tadalafil) tablets   X X X    
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Accutane (isotretinoin) capsules     X      
Bystolic (nebivolol) tablets     X X    

Carbocaine (mepivacaine HCl) injection

*risk of chondrolysis

    X      
Didrex (benzphetamine hydrochloride) tablets     X X X  
Excedrin Migraine (250 mg acetaminophen/ 250 mg aspirin/ 65 mg caffeine) tablets     X      
Genotropin (somatropin [rDNA origin] for injection     X X    
Lanoxin (digoxin) pediatric injection and tablets     X      

Marcaine (bupivacaine HCl) injection

 

Marcaine with Epinephrine 1:200,000 (as bitartrate)(bupivacaine HCl and epinephrine) injection

 

Marcaine Spinal (bupivacaine HCl) dextrose injection

*risk of chondrolysis

    X      

Naropin (ropivacaine HCl) injection

*risk of chondrolysis

    X      

Nesacaine (chloroprocaine HCl) injection

 

Nesacaine-MPF (chloroprocaine HCl) injection

*risk of chondrolysis

    X      
Norvasc (amlodipine besylate) tablets     X X X  
Prepidil (dinoprostone) cervical gel     X      
Rocephin (ceftriaxone sodium) IV and IM     X      
Savella (milnacipran HCl) tablets     X      
Treanda (bendamustine hydrochloride) for injection, for intravenous infusion     X X    

Xylocaine (lidocaine HCl) injection

 

Xylocaine (lidocaine HCl and epinephrine) injection

 

Xylocaine (lidocaine HCl) 4% solution

*risk of chondrolysis

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

BW

C

W

P

AR

PPI/MG
Cefoxitin for injection and Dextrose injection in the Duplex container       X    
Intelence (etravirine) 100 mg tablets       X    
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Dyazide (hydrochlorothiazide/triamterene) capsules        
X
 
Forane (isoflurane) liquid for inhalation        
X
 
Niaspan (niacin) extended release tablets        
X
 
Pristiq (desvenlafaxine) extended-release tablets        
X