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

Safety

  • Print
  • Share
  • E-mail

April 2009

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
Extraneal (icodextrin) Peritoneal Dialysis Solution
X
X
X
X  
Remicade (inflximab) IV Infusion X   X   X MG
(Click on drug name to go to detailed view) BW C W P AR PPI/MG
Orap (pimozide) 1 and 2 mg tablets   X   X    
Prevpac (lansoprazole 30 mg/amoxicillin 500 mg/clarithromycin 500 mg)   X   X X  
Soma Compound (200 mg of carisoprodol and 325 mg of aspirin)   X X X X  
(Click on drug name to go to detailed view) BW C W P AR PPI/MG
Aleve (220 mg naproxen sodium) caplet, tablet, and gelcap [OTC]     X      
Aleve Liquid Gels (220 mg naproxen sodium) capsules     X      
Aleve-D Sinus & Cold and Aleve-D Sinus & Headache (naproxen sodium, 220 mg and pseudoephedrine HCl, 120 mg) extended-release tablets     X      
Axert (almotriptan) tablets     X X    

Carbatrol (carbamazepine) Extended-Release Capsules

 

*antiepileptic drugs label change

    X X    

Celontin (methsuximide) Capsules

 

*antiepileptic drugs label change

    X X    

Depakene (valproic acid) Capsules and Oral Solution

 

*antiepileptic drugs label change

    X X    

Depakote (divalproex sodium) Delayed Release Tablets

 

Depakote ER (divalproex sodium) Extended Release Tablets

 

Depakote (divalproex sodium) Sprinkle Capsules

 

*antiepileptic drugs label change

    X X    
Depo-Medrol (methylprednisolone acetate injectable suspension, USP)     X X X  

Dilantin-125 (phenytoin oral suspension, USP) Suspension

 

*antiepileptic drugs label change

    X X    
Doribax (doripenem for injection)     X X X  
Enlon Plus (edrophonium chloride and atropine sulfate, USP) Injection     X      

Equetro (carbamazepine) Extended-Release Capsules

 

*antiepileptic drugs label change

    X X    
Exjade (deferasirox) Tablets for oral suspension     X X    
Felbatol (felbamate) Tablets and Oral Suspension     X X    

Gabitril (tiagabine hydrochloride) Tablets

 

*antiepileptic drugs label change

    X X    
Heparin Sodium Injection, USP     X      
Ibuprofen 200 mg capsules     X      

Kaletra (lopinavir/ritonavir) 200 mg/50 mg, 100 mg/25 mg Tablets

 

Kaletra (lopinavir/ritonavir) 80 mg/20mg per ml Oral Solution

    X X X MG

Keppra (levetiracetam) Tablets and Oral Solution

 

Keppra XR (levetiracetam) Extended-Release Tablets

 

*antiepileptic drugs label change

    X X    

Klonopin (clonazepam) Tablets

 

Klonopin (clonazepam orally disintegrating tablet) Wafers

 

*antiepileptic drugs label change

    X X    

Lamictal (lamotrigine) Tablets and Chewable Dispersible Tablets

 

*antiepileptic drugs label change

    X X    

Lyrica (pregabalin) Capsules

 

*antiepileptic drugs label change

    X X    
Midol Extended Relief (220 mg naproxen sodium) caplet [OTC]     X      

Motrin

 

Children’s Motrin (100 mg/5 mL ibuprofen) suspension [OTC]

 

Motrin IB (200 mg ibuprofen) tablets [OTC]

 

Motrin Infants’ Drops (50 mg/1.25 mL ibuprofen oral suspension) [OTC]

 

Motrin Junior Strength (100 mg ibuprofen) chewable tablets & Junior Strength Motrin (100 mg ibuprofen) tablets [OTC]

    X      
Children’s Motrin Cold (100 mg/5 ml ibuprofen and 15 mg/5 ml pseudoephedrine HCl) suspension     X      

Mysoline (primidone) 50 mg and 250 mg Tablets

 

*antiepileptic drugs label change

    X X    

Neurontin (gabapentin) Capsules, Tablets, and Oral Solution

 

*antiepileptic drugs label change

    X X    

Peganone (ethotoin) 250 mg Tablets

 

*antiepileptic drugs label change

    X X    
Sarafem (fluoxetine hydrochloride) Tablets     X   X  

Stavzor (valproic acid) Delayed Release Capsules

 

*antiepileptic drugs label change

    X X    
Tarceva (erlotinib) Tablets     X X    
Tegretol (carbamazepine) Tablets, Chewable Tablets, Suspension, and Extended-Release Tablets     X X    
Topamax (topiramate) 25, 50, 100 and 200 mg Tablets and 15 mg and 25 mg Sprinkle Capsules     X X X  

Tranxene (clorazepate dipotassium) Tablets

 

*antiepileptic drugs label change

    X X    
Treanda (bendamustine hydrochloride) for Injection, 100 mg     X X    

Tridione (trimethadione) Tablets

 

*antiepileptic drugs label change

    X X    

Trileptal (oxcarbazepine) Tablets and Suspension

 

*antiepileptic drugs label change

    X X    

Zarontin (ethosuximide) Capsules

 

*antiepileptic drugs label change

    X X    

Zonegran (zonisamide) Capsules

 

*antiepileptic drugs label change

    X X    
(Click on drug name to go to detailed view) BW C W P AR PPI/MG
Arava (leflunomide) oral tablets, 10mg, 20mg, 100mg       X    
CeeNu (lomustine) Capsules       X    
Cordarone (amiodarone HCl) 200 mg Tablets       X X  
Glycet (miglitol) Tablets       X    
Kayexalate (sodium polystyrene sulfonate, USP) Powder       D & A    
Mavik (trandolopril) 1, 2, and 4 mg Tablets       X    
Minipress (prazosin hydrochloride) 1, 2, and 5 mg Capsules       X X  
(Click on drug name to go to detailed view) BW C W P AR PPI/MG
Copegasus-ß (ribavirin) 200 mg tablets in combination with Pegasys-ß (peginterferon alfa-2a)         X MG
Duraclon (clonidine hydrochloride) injection, solution         X  
Lovaza (omega-3-acid ethyl esters) Capsules         X  
Metadate CD (methylphenidate HCl, USP) 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg Extended-Release Capsules         X  
Mifeprex (mifepristone) Tablets         X  
Suprane (desflurane, USP)         X  
(Click on drug name to go to detailed view) BW C W P AR PPI/MG

Avelox (moxifloxacin hydrochloride) Tablets

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

            MG

Cipro (ciprofloxacin hydrochloride) Tablets

Cipro IV (ciprofloxacin) 1% Solution in Vials

Cipro IV (ciprofloxacin) 0.2% Solution in 5% Dextrose

Cipro (ciprofloxacin) Oral Suspension

Cipro XR (ciprofloxacin extended-release tablets)

          MG
Detrol (tolterodine tartrate) tablets, 1 and 2 mg           MG
Factive (gemifloxacin mesylate) Tablets           MG

Levaquin (levofloxacin) Tablets

Levaquin (levofloxacin) Injection

Levaquin (levofloxacin in 5% dextrose) Injection

Levaquin (levofloxacin) Oral Solution

          MG
Noroxin (norfloxacin) Tablets           MG
Proquin XR (ciprofloxacin HCl extended-release) Tablets           MG