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U.S. Department of Health and Human Services

Safety

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January 2013

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, PCI=Patient Counseling Information, 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
Brilinta (ticagrelor) 90 mg Tablets X  XMG
Complera (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) 200 mg/25 mg /300 mg fixed dose combination (FDC) tablets XXXXPCI
Prozac (fluoxetine HCl) 10 mg, 20 mg, and 40 mg capsules
Prozac (fluoxetine HCl) delayed-release 90 mg capsules
 
 XXX MG
Symbyax (olanzapine and fluoxetine HCl) Capsules 3 mg/25 mg, 6 mg/25 mg, 12 mg/25 mg, 6 mg/50 mg, 12 mg/50 mg XXXXPCI/MG
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Ampyra (dalfampridine)  XX PCI
Bentyl (dicyclomine hydrochloride, USP) Capsules/Tablets 10 mg, 20 mg
Bentyl (dicyclomine hydrochloride, USP) Injection 10 mg/mL
  XXX 
Cancidas (caspofungin acetate)   XXXPCI 
Ciprofloxin  XXX 
Fanapt (iloperidone) 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg tablets
 
  XXX 
Gelnique (oxybutynin chloride), 3 percent gel  XX  
Heparin Sodium in 5 percent Dextrose Injection in Excel  X   
Heparin Sodium in 0.9 percent Sodium Chloride Injection in Excel  X   
Lipofen (fenofibrate) Capsules, 50 mg and 150 mg  XXX 
Peridex (chlorhexidine gluconate) Oral Rinse, 0.12 percent  X  PI
Pre-Scrub (chlorhexidine gluconate) 4 percent Surgical Hand Scrub  X   
Reyataz (atazanavir sulfate), 100 mg, 150 mg, 200 mg and 300 mg capsules  XXXPCI/PPI
Stelara (ustekinumab)  XX MG
Triglide (fenofibrate) Tablets, 50 mg and 160 mg  XXX 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Augmentin (amoxicillin/clavulanate potassium) Tablets, 250 mg/125mg and 500 mg/125 mg
Augmentin (amoxicillin/clavulanate potassium) Powder for Oral Suspension
Augmentin (amoxicillin/clavulanate potassium) Chewable Tablets
Augmentin (amoxicillin/clavulanate potassium) Tablets, 875mg/125 mg
Augmentin (amoxicillin/clavulanate potassium) Oral Suspension
Augmentin (amoxicillin/clavulanate potassium) Chewable Tablets
 
   X  
Clolar (clofarabine) Injection    XX 

Kaletra (lopinavir/ritonavir) 133.3mg/mL/33.3 mg/mL soft gelatin capsules

Kaletra (lopinavir/ritonavir) 80/20 mg/mL oral solution and 100/25mg and 200/50mg tablets

   X PCI/MG 
Norvasc (amlodipine besylate) 2.5 mg, 5.0 mg and 10 mg Tablets    X  
TriLuma (fluocinolone acetonide, 0.01 percent, hydroquinone, 4 percent, tretinoin, 0.05 percent) Cream   X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Proscar (finasteride) 5mg Tablets     
X
 
Tyzeka (telbivudine) 600 mg Tablets and 100 mg/5 mL Oral    X 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Dulera (mometasone furoate/formoterol fumarate) Inhalation Aerosol     MG
Opana ER (oxymorphone hydrochloride extended-release) Tablets, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg, and 40 mg      PCI