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

Safety

  • Print
  • Share
  • E-mail

March 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, PCI=PATIENT COUNSELING INFORMATION

 
         
DRUG NAME
SECTIONS MODIFIED
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Plavix (clopidogrel bisulfate) tablets
X
  X X   PCI
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Caduet (amlodipine besylate/atorvastatin calcium) tablet   X X X X  
Lotrel (amlodipine besylate/benazapril hydrochloride) capsule   X X X X  
Meridia (sibutramine hydrochloride) capsules   X X X    
Skelid (tiludronate disodium) tablets   X X X    
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Avelox (moxifloxacin) tablets and I.V.     X   X  
ChloraPrep [chlorhexidine gluconate (2% w/v) and isopropyl alcohol (70% v/v)] solution [OTC]     X      
DuraPrep Surgical (iodine povacrylex (0.7% available iodine) and isopropyl alcohol (74% w/w)) solution     X      
Emend (fosaprepitant dimeglumine) for injection     X X    
Femara (letrozole) 2.5 mg tablets     X X X  
Fosamax Plus D (alendronate sodium/cholecalciferol) tablets     X X X PPI
Hycamtin (topotecan hydrochloride) injection     X X    
Rapaflo (silodosin) capsules     X X    
Sustiva (efavirenz) capsules and tablets     X X X PPI
Toprol XL (metoprolol succinate) extended release tablets     X   X  
Vivitrol (naltrexone for extended-release) injectable suspension     X X    
Vytorin (ezetimibe/simvastatin) tablets     X X    
Zocor (simvastatin) tablets     X X    
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Adalat (nifedipine) extended release tablets       X    
Arixtra (fondaparinux sodium) injection       X    
Cardura XL (doxazosin mesylate) extended release tablets       X    
Fosamax (alendronate sodium) tablets and oral solution       X X PPI
Isoptin SR (verapamil HCL) sustained release tablets       X    
Nexium (esomeprazole magnesium) capsules, oral suspension, and for injection       X    
Percodan (oxycodone and aspirin) tablets       X    
Prilosec (omeprazole magnesium) delayed-release capsules and oral suspension       X    
Propecia (finasteride) 1 mg tablet       X   MG
Proscar (finasteride) 5 mg tablets       X   PPI
Vanos (fluocinonide) cream       X    
Verelan (verapamil hydrochloride) capsule       X    
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Copegus (ribavirin) tablet        
X
 
Dexilant (former Kapidex) (dexlansoprazole) delayed release capsules        
X
 
Emend (aprepitant) capsules        
X
 
Exforge (amlodipine and valsartan) tablets         X  
Inderide (propranolol HCl/hydrochlorothiazide) tablets         X  
Invega (paliperidone) extended-release tablets        
X
 
Isentress (raltegravir potassium) tablets        
X
 
Pepcid (famotidine) tablets         X  
Relenza (zanamivir) Inhalation Powder for oral inhalation        
X
 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Promacta (eltrombopag) tablets           MG