Safety

September 2014

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
Lumizyme (aglucosidase alfa)X XXXPCI
Pegasys (peginterferon alfa-2a) 
X
XXX MG
Revlimid (lenalidomide) Capsules 2.5, 5, 10, 15, 20, and 25 mgX XX PCI
Xylocaine Viscous (lidocaine HCl) Solution, 2 percent
X
 XX  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Arthrotec (diclofenac sodium/misoprostol) Oral Tablets  XXXX 
Halcion (triazolam) tablets, 0.25 mg XXX  
Ozurdex (dexamethasone intravitreal implant) 0.7 mg  XXX  MG
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG

Aloxi (palonosetron hydrochloride) Injection 

*Serotonin Syndrome

  X PCI

Aloxi (palonosetron hydrochloride) Oral Capsules

*Serotonin Syndrome

  XX PCI

Anzemet (dolasetron mesylate) injection, 20 mg/mL

*Serotonin Syndrome

  XX PCI

Anzemet (dolasetron mesylate) tablets, 50 mg and 100 mg

*Serotonin Syndrome

  XX PCI
Chantix (varenicline) Tablets; 0.5 mg and 1 mg  XXX 
Clolar (clofarabine) Injection, 1 mg/mL   XXX 
Docetaxel Injection Concentrate, 20 mg/1 mL, 80 mg/4 mL, and 140 mg/7 mL   XXX 
Genotropin (somatropin [rDNA origin] for injection)   XX  
Hyzaar (losartan potassium/hydrochlorothiazide) 50/12.5 mg, 100/12.5 mg, and 100/25 mg Tablets   XX  
Latisse (bimatoprost ophthalmic solution), 0.03 percent   XXXPCI
Lexiscan (regadenoson) Injection  XXXPCI
Lumigan (bimatoprost ophthalmic solution), 0.03 percent  XX  
Lumigan (bimatoprost ophthalmic solution), 0.01 percent  XXX 
MembraneBlue (trypan blue ophthalmic solution) 0.15 percent  XX  
Minivelle (estradiol transdermal system) 0.025 mg/day, 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day, and 0.1 mg/day  XXX 
Norditropin Cartridges (somatropin [rDNA origin] injection)  XX  

Sancuso (granisetron) 

*Serotonin Syndrome

  XX PCI
Vibramycin (doxycycline hyclate) Intravenous  X   
Vibramycin Monohydrate (doxycycline monohydrate) for Oral Suspension
Vibramycin (doxycycline hyclate) Capsules
Vibramycin Calcium (doxycycline calcium oral suspension) Syrup
Vibra-Tabs (doxycycline hyclate) Film Coated Tablets
  X   
Xolair (omalizumab)   XX MG

Zofran (ondansetron hydrochloride) Injection 

*Serotonin Syndrome

  X PCI

Zofran (ondansetron hydrochloride) Tablets

*Serotonin Syndrome

  XX PCI

Zofran (ondansetron hydrochloride) Oral Solution

*Serotonin Syndrome

  XX PCI
Zofran ODT (ondansetron) Orally Disintegrating Tablets

*Serotonin Syndrome

  XX PCI

Zuplenz (ondansetron) oral soluble film

*Serotonin Syndrome

  XX PCI
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG

Azor (amlodipine/olmesartan medoxomil) 5/20 mg, 10/20 mg, 5/40 mg, and 10/40 mg Tablets 

* RAS Dual Blockade

   X  

Benicar (olmesartan medoxomil) 5 mg, 20 mg, and 40 mg Tablets

* RAS Dual Blockade

   X  

Benicar HCT (olmesartan medoxomil/hydrochlorothiazide) 20/12.5 mg, and 40.12.5 mg, and 40/25 mg Tablets 

* RAS Dual Blockade

   X  
Cozaar (losartan potassium) 25 mg, 50 mg, and 100 mg Tablets    X PI

Diovan (valsartan) 80 mg and 160 mg Capsules

* RAS Dual Blockade

   X  

Diovan (valsartan) 40 mg, 80 mg, 160 mg, and 320 mg Tablets

* RAS Dual Blockade

   X  
Emsam (Selegiline Transdermal System) 6 mg/24 hours, 9 mg/24 hours, and 12 mg/24 hours    X PCI

Exforge (amlodipine/valsartan) 5/160 mg, 10/160 mg, 5/320 mg, and 10/320 mg Tablets 

* RAS Dual Blockade

   X  

Exforge HCT (amlodipine/valsartan/hydrochlorothiazide) 5/160/12.5 mg, 10/160/12.5 mg, 5/160/25 mg, 10/160/25 mg, and 10/320/25 mg Tablets

* RAS Dual Blockade

    X  
Fosrenol (lanthanum carbonate) chewable tablets 500 mg, 750 mg and 1000 mg    X  
Namenda XR (memantine hydrochloride extended-release) Capsule, 7 mg, 14 mg, 21 mg, and 28 mg    XX 
Nulojix (belatacept)    X  
Olysio (simeprevir), 150 mg capsules    X  
Qsymia (phentermine and topiramate extended-release) capsules   XX 
Tasigna (nilotinib) capsules, 150 and 200 mg    X  

Tegretol (carbamazepine) Tablets, Chewable Tablets, Oral Suspension, Tegretol-XR (carbamazepine extended-release)  

   XX 

Tribenzor (olmesartan /medoxomil / amlodipine / hydrochlorothiazide) 20/5/12.5 mg, 40/5/25 mg, 40/10/12.5 mg, and 40/10/25 mg Tablets 

* RAS Dual Blockade

   X  
Velphoro (sucroferric oxyhydroxide) Chewable Tablets, 500 mg Iron    X PCI
Zoloft (sertraline hydrochloride) 20mg/mL Oral Concentrate    X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Clozaril (clozapine) 25 mg and 100 mg tablets     
X
 
Invanz (ertapenem) Injection, 1 gm     
X
 
Megace ES (megestrol acetate) oral suspension, 125 mg/mL     X 
Pradaxa (dabigatran etexilate mesylate) 75 and 150 mg Capsules    X 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
       
 
 
   

 

Page Last Updated: 10/16/2014
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