• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Safety

  • Print
  • Share
  • E-mail

January 2009

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
Cimzia (certolizumab pegol) X  
 X
   
 X
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG

Avelox (moxifloxacin hydrochloride) Tablets, 400 mg

Avelox (moxifloxacin hydrochloride in NaCl injection) I.V., 160 mg/mL

    X  
 X
 

Celexa (citalopram hydrobromide) tablets

Celexa (citalopram hydrobromide) solution

Lexapro (escitalopram oxalate) tablets

Lexapro (escitalopram oxalate) oral solution

    X      
Cymbalta (duloxetine hydrochloride) Delayed-Release Capsules 20, 30 and 60 mg     X      
Effexor XR (venlafaxine HCl) Extended-Release Capsules and Effexor (venlafaxine HCl) Tablets     X      
Hycodan (hydrocodone and homatropine) Tablets     X X
 
Nicardipine Hydrochloride Injection 25 mg/Vial, 2.5 mg/ml     X X    

Paxil (paroxetine HCl) tablets

Paxil (paroxetine HCl) CR tablets

Paxil (paroxetine) oral suspension

    X      
Pexeva (paroxetine mesylate) tablets     X      
Pristiq (desvenlafaxine succinate) Extended-Release tablets     X      

Prozac (fluoxetine HCl) pulvules

Prozac (fluoxetine HCl) oral solution

Prozac Weekly (fluoxetine HCl) delayed-release capsules

    X      
Tygacil (tigecycline)     X X X  
Tyzeka (telbivudine) 600 mg tablets     X      
Venlafaxine hydrochloride extended release tablets     X      
Zoloft (sertraline HCl) Tablets and Oral Concentrate     X      
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
ActoPlus Met (pioglitazone HCl plus metformin HCl tablets), 15 mg/500mg and 15 mg/850 mg       X    
Duetact (pioglitazone HCl plus glimepiride fixed-dose combination tablets), 30 mg/2 mg and 30 mg/4 mg       X    

Lotensin (benazepril hydrochloride) 2.5, 5, 10 and 20 mg

Lotensin HCT (benazepril/hydrochlorothiazide) 5/6.25, 10/12.5, 20/12.5 and 20/25mg Tablets

      X    
Nexium IV (esomeprazole sodium) for Injection       X    
Nexium (esomeprazole magnesium) for Delayed-Release Capsules and Delayed-Release Oral Suspensions       X    
Plasma-Lyte 148 and 5% Dextrose Injection in Plastic Container Plasma-Lyte 148 Injection in Plastic Container (includes Plasma-Lyte A Injection pH 7.4)       X    
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Augmentin ES-600 (amoxicillin/clavulanate potassium) 600 mg/5 mL Powder for Oral Suspension        
X
 
Isentress (raltegravir potassium) 400 mg tablets        
X
X

Rapamune (sirolimus) Oral Solution

Rapamune (sirolimus) Tablets

       
X
 
Singulair (montelukast sodium) tablets, chewable tables and oral granules        
X
X
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Crestor (rosuvastatin calcium) Tablets          
Vytorin (ezetimibe/simvastatin) Tablets