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U.S. Department of Health and Human Services

Safety

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February 2011

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

Avandia (rosiglitazone maleate)

Avandamet (rosiglitazone maleate/metformin hydrochloride)

Avandaryl (rosiglitazone maleate/glimepiride) Tablets

X XXX 

Avelox (moxifloxacin hydrochloride) tablets and Avelox (moxifloxacin hydrochloride in NaCl injection) I.V.

* Exacerbation of myasthenia gravis 

X
 XXXMG
Cipro (ciprofloxacin hydrochloride) Tablets, Oral Suspension, IV and Cipro XR (ciprofloxacin extended-release tablets)
* Exacerbation of myasthenia gravis
X
 XXXMG

Factive (gemifloxacin mesylate) Tablets

* Exacerbation of myasthenia gravis

X
 XXXMG

Floxin (ofloxacin) Tablets

* Exacerbation of myasthenia gravis

X
 XXXMG

Levaquin (levofloxacin) Tablets, Oral Solution and Injection

* Exacerbation of myasthenia gravis

X
 XXXMG

Noroxin (norfloxacin) Tablets

* Exacerbation of myasthenia gravis

X
 XXXMG

Proquin XR (ciprofloxacin) Extended-Release Tablets

* Exacerbation of myasthenia gravis

X
 XXXMG
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Flector Patch (diclofenac epolamine topical patch) X    
Increlex (mecasermin [rDNA origin] injection
 
 X X  X  
Toviaz (fesoterodine fumarate) extended release tablets XX X   
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Heparin Sodium Injection  X   
Humatrope (somatropin [rDNA origin]) for injection
 
  XXX 
Kaletra (lopinavir/ritonavir) Tablets and Oral Solution  XX  MG 
Multaq (dronedarone hydrochloride) Tablets  XXX 
Prilosec OTC (omeprazole magnesium) delayed-release tablets  X   
Promacta (eltrombopag) Tablets
  XX  
Remicade (Infliximab)
 
  X X X 

Tekturna (aliskiren)and Tekturna HCT(aliskiren/hydrochlorothiazide) Tablets

  XXX 
Valturna (aliskiren/valsartan) Tablets  XXX 

Zebeta (bisoprolol fumarate) Tablets

  X   
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Adalat CC (nifedipine)  Extended Release Tablets   XX 
Betapace (sotalol hydrochloride) and Betapace AF (sotalol hydrochloride) Tablets   X  
Cataflam (diclofenac potassium immediate-release tablets)
 
   XX 
NebuPent (pentamidine isethionate)
 
   X  
Talwin Nx (pentazocine hydrochloride and naloxone Hydrochloride) Tablets   X  
Tazorac (tazarotene) Gel
 
   X X  
Viracept (nelfinavir mesylate) Oral Powder and Tablets
 
   X PPI 
Voltaren (diclofenac sodium enteric-coated tablets) and Voltaren-XR (diclofenac sodium extended-release) tablets   XX 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Adenoscan (adenosine) Injection    
X
 

Diabinese (chlorpropamide) tablets

*sulfonylurea agent class change

    
X
 

Glucotrol and Glucotrol XL (glipizide) tablets

*sulfonylurea agent class change

    
X
 

Glynase (micronized glyburide) tablets

*sulfonylurea agent class change

    
X
 
Isentress (raltegravir potassium) Tablets
 
    
X
PCI

Metaglip (glipizide/metformin HCl fixed-dose combination) tablets

*sulfonylurea agent class change

    
X
 

Micronase (glyburide) tablets

*sulfonylurea agent class change

    
X
 
Pegasys (ß (peginterferon alfa-2a)
 
    
X
 
Simcor (niacin extended release/simvastatin) Tablets    
X
 
Vantas (histrelin acetate) subcutaneous implant    
X
 
Zometa (zoledronic acid for injection)
 
    X 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Brovana (arformoterol) Inhalation Solution     MG
Perforomist (formoterol fumarate) Inhalation Solution     MG
Plavix (clopidogrel bisulfate) Tablets
 
      MG 
Symbicort (budesonide and formoterol) Inhalation Aerosol
 
     MG