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U.S. Department of Health and Human Services

Safety

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September 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, 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
Arzerra (ofatumumab) InjectionX XX  
CombiPatch (estradiol/norethindrone acetate transdermal system) 
X
XXXXPI 
Potiga (ezogabine) tablets 50 mg, 200 mg, 300 mg, 400 mg 
X
  X X  
Rituxan (rituximab)X XX  
Tasigna (nilotinib) capsules, 150 mg and 200 mgX XX PCI
Tygacil (tigecycline) for Injection
 
X XXX 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Accupril (quinapril hydrochloride) 5 mg, 10 mg, 20 mg, and 40 mg Tablets XXX  
Accuretic (quinapril hydrochloride/HCTZ) 10/12.5 mg, 20/12.5 mg, and 20/25 mg Tablets XXX  
Altace (ramipril) 1.25 mg, 2.5 mg, 5 mg, and 10 mg XXX  
Arixtra (fondaparinux sodium) injection  X  X 
Janumet (sitagliptin and metformin HCl) tablets, 50 mg/ 500 mg and 50 mg/ 1000 mg XXXXMG
Plasma-Lyte 148 and Plasma-Lyte A pH 7.4 (Multiple Electrolytes, Type 1, USP) Injection XXXX 
Septra and Septra DS (Trimethoprim and Sulfamethoxazole) Tablets  XXXX 
Suprane (desflurane, USP) XXX  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Apidra (insulin glulisine [rDNA origin]) injection   X PCI 
CellCept (mycophenolate mofetil)  X   
Biaxin Filmtabs (clarithromycin tablets, USP)
Biaxin Filmtabs (clarithromycin tablets, USP)
Biaxin Granules (clarithromycin for oral suspension, USP)
Biaxin XL Filmtabs (clarithromycin extended release tablets) 

 
  XX  
Gemcitabine Injection 38 mg/mL   X  
Golytely (PEG 3350 and electrolytes) for Oral Solution, 1 Gallon and 4 Liter  XX MG
Jentadueto (linagliptin and metformin hydrochloride) tablets, 2.5 mg/500 mg, 2.5 mg/850 mg, and 2.5 mg/1000 mg
 
  XX  
Myfortic (mycophenolic acid) Delayed-Release Tablets
 
  XX  
Nulytely (PEG 3350 and electrolytes) for Oral Solution  XX MG
Plavix (clopidogrel bisulfate) 75 mg Tablets  XXXMG
Prograf (tacrolimus) Capsules, 0.5 mg, 1 mg, and 5 mg
Prograf (tacrolimus) Injection, 5 mg/ml
  XXX 
Remodulin (treprostinil) 20 mg, 50 mg, 100 mg, and 200 mg for Injection   X XXPCI
Terazol 7 (terconazole) Vaginal Cream, 0.4%
Terazol 3 (terconazole) Vaginal Suppositories, 80 mg
Terazol 3 (terconazole) Vaginal Cream, 0.8%
  X X 
Unisom SleepTabs (doxylamine succinate) Tablets, 25mg  X   
Vimpat (lacosamide) tablets
Vimpat (lacosamide) Injection
Vimpat (lacosamide) oral solution

 
  XXX 
Zometa (zoledronic acid) Injection, 4 mg/100 mL single-use ready-to-use bottle and 4 mg/5 mL single-use vial of concentrate  XX  
Zosyn (piperacillin and tazobactam for injection, USP)
Zosyn (piperacillin and tazobactam injection) in Galaxy Containers (PL 2040 Plastic)
  XXX 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Anzemet (dolasetron mesylate)   XX 
Bosulif (bosutinib) Tablets, 100 mg and 500 mg    X  
Dextrose 5%, Sodium Chloride 0.2%, and Potassium Chloride Injections
Potassium Chloride in Dextrose 5% and Sodium Chloride Injections
 
   XX 
5% Dextrose and 0.9% Sodium Chloride Injection, USP in Plastic Container
2.5% Dextrose and 0.45% Sodium Chloride Injection, USP in Plastic Container
5% Dextrose and 0.2% Sodium Chloride Injection, USP in Plastic Container
10% Dextrose and 0.9% Sodium Chloride Injection, USP in Plastic Container
5% Dextrose and 0.45% Sodium Chloride Injection, USP in Plastic Container
5% Dextrose and 0.33% Sodium Chloride Injection, USP in Plastic Container
 
   XX 
Diflucan (fluconazole) Tablets
Diflucan (fluconazole) IV
Diflucan (fluconazole) Powder for Oral Suspension 
   X  
Makena (hydroxyprogesterone caproate injection) 250ml/mg    XX 
MoviPrep (PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution)   X  
Neupogen (filgrastim)    XX 

Sodium Chloride Injections:

0.9% Sodium Chloride Injection, USP in VIAFLEX Plastic Container; 0.9% Sodium Chloride Injection, USP in AVIVA Plastic Container
0.45% Sodium Chloride Injection, USP in VIAFLEX Plastic Container; 0.45% Sodium Chloride Injection, USP in AVIVA Plastic Container
Ringer’s Injection, USP 

   XX 
Tobi (tobramycin inhalation solution, USP) 300mg/5mL
 
   XX 
Vibramycin Monohydrate (doxycycline monohydrate) for Oral Suspension
Vibramycin Hyclate (doxycycline hyclate capsules, USP) Capsules
Vibramycin Calcium (doxycycline calcium oral suspension) Syrup
Vibra-Tabs (doxycycline hyclate tablets, USP) Film Coated Tablets
 
   XX 
Victrelis (boceprevir), 200 mg capsules    X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Alimta (pemetrexed for injection) for intravenous use, 100 mg and 500 mg vials     
X
 
Inlyta (axitinib) tablets    X 
Macrobid (nitrofurantoin monohydrate 75 mg/nitrofurantoin macrocrystals 25 mg) Capsules     
X
 
Macrodantin (nitrofurantoin macrocrystals) Capsules     X 
Xopenex HFA (levalbuterol tartrate) Inhalation Aerosol    X 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Fortesta (testosterone gel)     MG
Skyla (levonorgestrel-releasing intrauterine system)      PI