/* mobile /* end mobile MEDDESKTOP: Drug Safety Labeling Changes February 2010

Thursday, March 25, 2010

Drug Safety Labeling Changes February 2010

 Drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections during February 2010.
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) tablets1   X X X X  
Cialis (tadalafil) tablets2   X X X    
(Click on drug name to go to detailed view)
BW
C
W
P
AR
PPI/MG
Accutane (isotretinoin) capsules3     X      
Bystolic (nebivolol) tablets4     X X    
Carbocaine (mepivacaine HCl) injection5
*risk of chondrolysis
    X      
Didrex (benzphetamine hydrochloride) tablets6     X X X  
Excedrin Migraine (250 mg acetaminophen/ 250 mg aspirin/ 65 mg caffeine) tablets7     X      
Genotropin (somatropin [rDNA origin] for injection8     X X    
Lanoxin (digoxin) pediatric injection and tablets9     X      
Marcaine (bupivacaine HCl) injection10

Marcaine with Epinephrine 1:200,000 (as bitartrate)(bupivacaine HCl and epinephrine) injection11

Marcaine Spinal (bupivacaine HCl) dextrose injection12
*risk of chondrolysis
    X      
Naropin (ropivacaine HCl) injection13
*risk of chondrolysis
    X      
Nesacaine (chloroprocaine HCl) injection14

Nesacaine-MPF (chloroprocaine HCl) injection15
*risk of chondrolysis
    X      
Norvasc (amlodipine besylate) tablets16     X X X  
Prepidil (dinoprostone) cervical gel17     X      
Rocephin (ceftriaxone sodium) IV and IM18     X      
Savella (milnacipran HCl) tablets19     X      
Treanda (bendamustine hydrochloride) for injection, for intravenous infusion20     X X    
Xylocaine (lidocaine HCl) injection21

Xylocaine (lidocaine HCl and epinephrine) injection22

Xylocaine (lidocaine HCl) 4% solution23
*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 container24       X    
Intelence (etravirine) 100 mg tablets25       X    
(Click on drug name to go to detailed view)
BW
C
W
P
AR
PPI/MG
Dyazide (hydrochlorothiazide/triamterene) capsules26        
X
 
Forane (isoflurane) liquid for inhalation27        
X
 
Niaspan (niacin) extended release tablets28        
X
 
Pristiq (desvenlafaxine) extended-release tablets29        
X
 

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