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U.S. Department of Health and Human Services

Safety

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September 2011

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
Detrol (tolterodine tartrate) tablets and Detrol LA (tolterodine tartrate) extended release tablets XX XPPI
Orap (pimozide) 1 mg and 2 mg tablets  X X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Anzemet (dolasetron mesylate) tablets and Anzemet (dolasetron mesylate) injection   X   
Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate) tablets  XXX 
Avastin (bevacizumab)  XXXPCI 
Cymbalta (duloxetine hydrochloride) capsules  XX MG
Effient (prasugrel hydrochloride) 5 mg and 10 mg Tablets   XX MG
Ellence (epirubicin hydrochloride) injection  X   
Istodax (romidepsin) for Injection  XX  
Lexiscan (regadenoson) Injection  XXX 
MultiHance (gadobenate dimeglumine) injection  XX  
Nicorette (nicotine polacrilex) 2 mg and 4mg gum [OTC]  X   
Procardia (nifedipine) 10 mg Capsules  X X 
Procardia XL (nifedipine) 30 mg, 60 mg, and 90 mg Extended Release Capsules  X X 
Risperdal (risperidone) tablets, oral solution
Risperdal M-Tab (risperidone) orally disintegrating tablets
Risperdal Consta (risperidone) long-acting injection
  XX  
Stimate (desmopressin acetate) 1.5 mg/mL nasal spray   X   
Sustenna (paliperidone palmitate) Extended-Release Injectable Suspension for intramuscular use  XX  
Xenon Xe 133 Gas, 10 and 20 mCi, septum sealed glass vial   X   
Zofran (ondansetron hydrochloride) injection and premixed injection  X   
Zofran (ondansetron hydrochloride) tablets, oral solution, and orally disintegrating tablets   X   
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Claforan (cefotaxime sodium) Injection    X  
Mavik (trandolapril) 1 mg, 2 mg and 4 mg Tablets   X  
Sanctura (trospium chloride) and Sanctura XR (trospium chloride extended release)    X  
Sustiva (efavirenz) Tablets and Capsules   X  
Tarka (trandolapril/verapamil hydrochloride) tablets   X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Aldactazide (spironolactone/hydrochlorothiazide) tablets    
X
 
Aldactone (spironolactone) tablets    X 
Fosrenol (lanthanum carbonate) 500 mg, 750 mg, and 1000 mg Chewable Tablets    X 
Latisse (bimatoprost) ophthalmic solution    
X
 
Lexiscan (regadenoson) injection    X 
Travatan (travoprost) and Travatan Z (travoprost)     
X
 
Vyvanse (lisdexamfetamine dimesylate)    X 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Doxorubicin (doxorubicin hydrochloride) for injection      PPI
Noroxin (norfloxacin) tablets     MG