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U.S. Department of Health and Human Services

Safety

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June 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

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

BW

C

W

P

AR

PPI/MG

Advair Diskus (fluticasone propionate and salmeterol xinafoate inhalation powder)

 

Advair HFA Inhalation Aerosol (fluticasone propionate and salmeterol xinafoate)

*Long-Acting Beta Agonists (LABAs) change

X
 MG 
Brovana Inhalation Solution (arformoterol tartrate)

*Long-Acting Beta Agonists (LABAs) change

X
 X XXMG 
Foradil Aerolizer (formoterol fumarate inhalation powder) and Foradil Certihaler (formoterol fumarate inhalation powder)

*Long-Acting Beta Agonists (LABAs) change

XMG 
Novantrone (mitoxantrone HCl) injectionX X    
Perforomist (formoterol fumarate) inhalation solutionX X X XMG 

Serevent Diskus (salmeterol xinafoate inhalation powder)

*Long-Acting Beta Agonists (LABAs) change

X
 X X XMG 

Symbicort Inhalation Aerosol (budesonide and formoterol)

 

*Long-Acting Beta Agonists (LABAs) change

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

BW

C

W

P

AR

PPI/MG
Ceftriaxone for Injection and Dextrose Injection in the Duplex Container X X  
Heparin Sodium injection X   
Kaletra (lopinavir/ritonavir) tablets and oral solution X   
Solu-Medrol (methylprednisolone sodium succinate) for injection X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Avodart (dutasteride) soft gelatin capsules  X 
Copegus (ribavirin) tablets  X   
Hycamtin (topotecan hydrochloride) capsules  X 
Ovidrel (choriogonadotropin alfa injection) prefilled syringe  X  
Rybix ODT (tramadol hydrochloride) orally disintegrating tablet  X   
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Clinoril (sulindac) tablets   X  
Cosopt (dorzolamide hydrochloride and timolol maleate) ophthalmic solution   X 
Dilacor XR (diltiazem HCl) extended release capsules   X  
Neupogen (filgrastim)    X  
Tasigna (nilotinib) capsules   X  
Trusopt (dorzolamide hydrochloride ophthalmic solution)   X  
Zylet (loteprednol etabonate and tobramycin) ophthalmic suspension   X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Acanya (clindamycin phosphate and benzoyl peroxide) gel    
X
PCI 
Dexilant (dexlansoprazole) delayed release capsules    
X
 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG

Peganone (ethotoin) tablets

     MG

Qualaquin (quinine sulfate USP) capsule

     MG
Tranxene T-Tab (clorazepate dipotassium) tablets      MG