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U.S. Department of Health and Human Services

Safety

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May 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

Codeine Sulfate Solution 

* Risk of respiratory depression and death in children

X
XXX  

Codeine Sulfate Tablets

* Risk of respiratory depression and death in children

XXXX  

Fioricet with Codeine (butalbital, acetaminophen, caffeine, and codeine phosphate) Capsules

* Risk of respiratory depression and death in children

XXXX  

Fiorinal with Codeine (butalbital, aspirin, caffeine, and codeine phosphate, USP) Capsules

* Risk of respiratory depression and death in children

XXXX  

Promethazine and Codeine Syrup

* Risk of respiratory depression and death in children

XXXX  

Promethazine, Phenylephrine and Codeine Syrup

* Risk of respiratory depression and death in children

XXXX  

Soma Compound with Codeine (carisoprodol, aspirin, and codeine phosphate) Tablets

* Risk of respiratory depression and death in children

XXXX  

SynalgosDC (dihydrocodeine bitartrate, aspirin and caffeine) Capsules

* Risk of respiratory depression and death in children

XXXX  
Vivelle-Dot (estradiol transdermal system) 
X
XX XXPI
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Kombiglyze XR (saxagliptin + metformin XR FDC) tablets X XPCI
Onglyza (saxagliptin)  X PCI
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Dyna-Hex 0.75 (chlorhexidine gluconate 0.75% solution)   X   
Gemzar (Gemcitabine for injection), 1g and 200 mg  XXX 
Humira (adalimumab)  XXX 
Inspra (eplerenone) 25 mg and 50 mg Tablets  XX  
Magnesium Sulfate in dextrose 5 percent injection, USP   XX  
Magnesium Sulfate Injection, USP, 50 percent   XX  
Magnesium Sulfate in Water for Injection, USP, in Flexible Plastic Container   XX  
Neoral Soft Gelatin Capsules (cyclosporine capsules, USP)
Neoral Oral Solution (cyclosporine oral solution, USP)
 
  XXX 
Rituxan (rituximab)  XX  
Sandimmune Injection (cyclosporine USP)
Sandimmune Oral Solution (cyclosporine USP)
Sandimmune Soft Gelatin Capsules (cyclosporine USP)
  XX  
Tasmar (tolcapone) 100 mg Tablets  XX  
Tysabri (Natalizumab) injection   XX PCI/MG 
Yervoy (ipilimumab)  XX  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Exjade (deferasirox) Tablets    XX 
Megace ES (megestrol acetate) Oral Suspension, 625 mg/5 ml    X  

Metadate CD (methylphenidate HCl) Extended-Release Capsules 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg 

   XXMG
Prilosec (omeprazole) Delayed- Release Granules for Oral Suspension, 2.5 mg and 10 mg
Prilosec (omeprazole) Delayed-Release Capsules, 10 mg, 20 mg, and 40 mg
 
   X  
Ritalin LA 10mg, 20mg, 30mg, and 40mg Capsules    X MG
Stivarga (regorafenib) Tablets, 40 mg    X  
Viracept (nelfinavir mesylate) Oral Powder, 50 mg/g
Viracept (nelfinavir mesylate) Tablets, 250 mg
Viracept (nelfinavir mesylate) Tablets, 625 mg
 
   X  
Zyvox (linezolid) Tablets
Zyvox (linezolid) IV Injection
Zyvox (linezolid) for Oral Suspension
 
   X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Arimidex (anastrozole) Tablets, 1 mg    
X
 
Concerta (methylphenidate HCL) 18 mg, 27 mg, 36 mg, and 54 mg Extended-Release Capsules     X 
Optimark and Optimark Pharmacy Bulk Package Injection    X 
Stelara (ustekinumab)    X 
Uroxatral (alfuzosin hydrochloride) extended-release tablets     
X
 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
PegIntron (peginterferon alfa-2b)     MG
Samsca (tolvaptan) 15 mg, and 30 mg Tablets     MG
Rebetol (ribavirin USP) 200 mg Capsules and 40 mg/mL Oral Solution      MG