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U.S. Department of Health and Human Services

Safety

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July 2011

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
Epogen/Procrit (epoetin alfa) and
Aranesp (darbepoetin alfa)
X
  X X   MG
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Dostinex (cabergoline) Tablets   X X      
Nitrostat (nitroglycerin, USP) Sublingual Tablets   X   X   PPI
Paxil (paroxetine HCl) tablets, oral solution and Paxil CR tablets    X   X    

Ranexa (Ranolazine) Extended-Release Tablets

  X X X   PCI
Rotavirus Vaccine, Live, Oral, Pentavalent (RotaTeq)   X       PPI
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Arava (leflunomide) Tablets      X X    
Bentyl (dicyclomine hydrochloride, USP) Capsules/Tablets, Oral Syrup, Injection     X X    
Chantix (varenicline) Tablets     X X X MG
Flomax (tamsulosin hydrochloride) Capsules     X X   PCI
Gilenya (fingolimod) capsules 0.5 mg      X X    
Kenalog-10 (triamcinolone acetonide) Injection
Kenalog-40 (triamcinolone acetonide) Injection
    X   X  
Micardis (telmisartan) Tablets       X    
Prograf (tacrolimus) Capsules, Injection     X X X  
Seroquel (quetiapine fumarate) Tablets
Seroquel (quetiapine fumarate) XR
    X X X MG
Tev-Tropin (somatropin [rDNA origin]) for injection     X X X  
Truvada (emtricitabine/tenofovir disoproxil fumarate) tablets     X X    
Zegerid OTC (omeprazole 20mg and sodium bicarbonate 1100 mg) capsules     X      
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Cordran (flurandrenolide, USP) Lotion       X X  
Creon (pancrelipase) delayed-release capsules       X X  

Kemadrin (procyclidine hydrochloride) Tablets

 
      X    
Mobic (meloxicam) Tablets, Oral Suspension       X    
Spiriva HandiHaler (tiotropium bromide inhalation powder)       X    
Wellbutrin XL (bupropion hydrochloride) Extended-Release Tablets
Aplenzin (bupropion hydrobromide) Extended-Release Tablets
      X   MG
Wellbutrin (bupropion hydrochloride)
Wellbutrin SR (bupropion hydrochloride) Sustained-Release Tablets 
      X   MG
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Coreg (carvedilol) Tablets
Coreg CR (carvedilol phosphate) Extended Release Capsules
       
X
 
Flovent HFA (fluticasone propionate) Inhalation Aerosol        
X
 
Ortho Evra (norelgestromin and ethinyl estradiol) transdermal system         X PPI
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Actiq (fentanyl citrate) oral transmucosal lozenge           MG
Colcrys (colchicine) Tablets           MG
Fentora (fentanyl buccal tablets)           MG
Tikosyn (dofetilide) Capsules           MG