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U.S. Department of Health and Human Services

Safety

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November 2010

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
Rifadin (rifampin capsules USP), and Rifadin (rifampin for injection USP) IV  X  
Rifater (rifampin, isoniazid and pyrazinamide) Tablets  X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG

Anectine (succinylcholine chloride injection, USP) 

*Severe anaphylactic reactions

  XX  

Arduan (pipecuronium bromide) Injection

*Severe anaphylactic reactions

  XX  
Feraheme (ferumoxytol) Injection   XX  
Metozolv ODT (metoclopramide hydrochloride)   X   

Mivacron (mivacurium chloride) Injection

*Severe anaphylactic reactions

  XX  

Nimbex (cisatracurium besylate) Injection

*Severe anaphylactic reactions

  XX  

Norcuron (vecuronium bromide) Injection

*Severe anaphylactic reactions

  XX  

Nuromax (doxacurium chloride) Injection

*Severe anaphylactic reactions

  XX  

Pavulon (pancuronium bromide) Injection

*Severe anaphylactic reactions

  XX  

Quelicin (succinylcholine chloride injection, USP)

*Severe anaphylactic reactions

  XX  
Rapamune (sirolimus) Oral Solution and Tablets  XXXX

Raplon (rapacuronium bromide) Injection

*Severe anaphylactic reactions

  XX  
Reglan (metoclopramide) Tablets, ODT, and Injection   X   
Revatio (sildenafil) Tablets and Injection  XX 

Zemuron (rocuronium bromide) Injection

*Severe anaphylactic reactions  

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

BW

C

W

P

AR

PPI/MG
Adderall XR (dextroamphetamine mixed salts of a single-entity amphetamine product) Capsules   X  
Cardizem CD (diltiazem hydrochloride) Capsules and Tablets
Cardizem LA (diltiazem hydrochloride) Extended-Release Tablets
 
   XX 
Metopirone (metyrapone USP) 250 mg, Capsules    XX 
Rozerem (ramelteon) Tablets   X  
Tiazac (diltiazem hydrochloride) Extended Release Capsules   XX 
Trandate (labetalol hydrochloride) Tablets and Injection   X  
Vfend (voriconazole) Tablets, Injection, and Oral Suspension    X  
Vyvanse (lisdexamfetamine dimesylate) Capsules    XX 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Byetta (exenatide) Injection     
X
 
Crestor (rosuvastatin calcium) Tablets    X 
Eraxis (anidulafungin) for Injection     
X
 
Glucovance (glyburide and metformin HCl) Tablets    X 
MoviPrep (PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride,Sodium Ascorbate, and Ascorbic Acid for Oral Solution)     
X
 
Nucynta (tapentadol) Immediate-release Oral Tablets    
X
 
Olux-E (clobetasol propionate) Foam, 0.05 %    X 
OxyContin (Oxycodone Hydrochloride Controlled-Release) Tablets    XX
Paraplatin (carboplatin) for Injection    X 
Tamiflu (oseltamivir phosphate) Capsules and Oral Suspension    
X
 
Sustiva (efavirenz) Tablets and Capsules     X 
Zocor (simvastatin) Tablets    X