• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Safety

  • Print
  • Share
  • E-mail

March 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
Brilinta (ticagrelor) Tablets  XXX  
Carafate (sucralfate) Suspension X  X 
Carafate (sucralfate) Tablets  X XX 
Wellbutrin (bupropion hydrochloride) Tablets and Wellbutrin SR (bupropion hydrochloride) Sustained-Release Tablets X  X 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Anaprox, Anaprox DS (naproxen sodium tablets)  X   
Avastin (bevacizumab)  XXX 
Clozaril (clozapine) Oral Tablets  X X 
Coly-Mycin M Parenteral Solution (colistimethate sodium, USP)  X   
EC-Naprosyn (naproxen delayed-release tablets)  X   
Erbitux (cetuximab)  XXX 
Firmagon (degarelix for injection)  XX  
Geodon (ziprasidone HCl) Capsules and Oral Suspension
Geodon (ziprasidone mesylate) Injection
  
  XX  

Humalog (insulin lispro [rDNA origin] injection) 

*Use of TZDs in combination with insulin

  XX PPI
Humalog Mix 50/50 (50% insulin lispro protamine suspension/50% insulin lispro [rDNA origin] injection)

*Use of TZDs in combination with insulin 

  XX PPI
Humalog Mix 75/25 (75% insulin lispro protamine suspension/25% insulin lispro [rDNA origin] injection)

*Use of TZDs in combination with insulin 

  XX PPI
INOmax (nitric oxide) for Inhalation   XXX 

Levemir (insulin detemir [rDNA origin] injection) 

*Use of TZDs in combination with insulin

  XX PPI
Lopressor (metoprolol tartrate) 50 mg / 100 mg Tablets
Lopressor (metoprolol tartrate) 5 mg / 5 ml injection

 
  XX  
Maxipime (cefepime hydrochloride, USP) for Injection  XXX 
Merrem I.V. (meropenem for injection)  XX PCI
Naglazyme (galsulfase)  XX  
Naprosyn (naproxen tablets)  X   

NovoLog (insulin aspart [rDNA origin] injection) 

*Use of TZDs in combination with insulin

  XX PPI

NovoLog Mix 50/50 (50% insulin aspart protamine suspension and 50% insulin aspart [rDNA origin] injection)

*Use of TZDs in combination with insulin

  XX PPI

NovoLog Mix 70/30 (70% insulin aspart protamine suspension and 30% insulin aspart [rDNA origin] injection)

*Use of TZDs in combination with insulin

  XX PPI
Remicade (infliximab)  XXX 
Rythmol (propafenone HCl) Tablets  XX  
Silvadene (silver sulfadiazine) Cream  X   
Tegretol (carbamazepine) Tablets, Chewable Tablets, Oral Suspension, and Tegretol-XR (carbamazepine extended-release) Tablets  XX  
Vectibix (panitumumab)   XX  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Arthrotec (diclofenac sodium/misoprostol) Oral Tablets    X  
Carbatrol (carbamazepine) Extended Release Capsules    XX 
Cerebyx (fosphenytoin sodium) Injection   X  
Dilantin-125 (phenytoin) Oral Suspension    X  
Dilantin (phenytoin sodium, USP) Injection    X  
Toradol (ketorolac tromethamine) Oral Tablets    X  
Visicol (sodium phosphate monobasic monohydrate, USP and sodium phosphate dibasic anhydrous, USP) Tablets    X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
ADDERALL XR (dextroamphetamine mixed salts of a single-entity amphetamine product) Capsules     
X
 
Mirapex (pramipexole dihydrochloride) Tablets and Mirapex ER (pramipexole dihydrochloride) Extended Release Tablets     
X
 
Multaq (dronedarone hydrochloride) Tablets    X 
Noroxin (norfloxacin) Tablets    X 
Rapamune (sirolimus) Oral Solution and Tablets    X 
Saphris (asenapine) Sublingual Tablets    XPCI
Trelstar (triptorelin pamoate for injectable suspension)    X 
VESIcare (solifenacin succinate) Tablets    X 
Voraxaze (glucarpidase)    X 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Cozaar (losartan potassium) Tablets      PI

Humulin 70/30 (70% human insulin isophane suspension/30% insulin human injection, rDNA origin)

*Use of TZDs in combination with insulin

     PPI

Humulin N NPH (human insulin isophane suspension [rNDA origin])

*Use of TZDs in combination with insulin

     PPI

Humulin R (insulin human injection, USP [rDNA origin])

*Use of TZDs in combination with insulin

     PPI
Hyzaar (losartan potassium/HCTZ) Tablets     PI

Novolin 70/30 (70% NPH, human insulin isophane suspension and 30% regular human insulin [rDNA origin]) Injection 

*Use of TZDs in combination with insulin

     PPI

Novolin N (NPH, human insulin isophane suspension [rDNA origin]) Injection 

*Use of TZDs in combination with insulin

     PPI