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Summary View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- November 2005

 

The summary view includes drug products with safety labeling changes to the CONTRAINDICATIONS, BOXED WARNING, WARNINGS, PRECAUTIONS, or ADVERSE REACTIONS 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 Contraindications or Warnings sections and a link to the revised prescribing information.

Key: C=CONTRAINDICATIONS, BW=BOXED WARNING, W=WARNINGS, P=PRECAUTIONS, AR=ADVERSE REACTIONS

 

DRUG NAME

SECTIONS MODIFIED

(Click on drug name to go to detailed view)

C

BW

W

P

AR

Cipro I.V. (ciprofloxacin) for Intravenous Infusion X   X  X  

Cipro (ciprofloxacin hydrochloride) Tablets

Cipro (ciprofloxacin) Oral Suspension

X    X  X  
Cipro XR (ciprofloxacin extended-release tablets) X   X X  
DDAVP Injection (desmopressin acetate)  X     X  

DDAVP Nasal Spray (desmopressin acetate)

X     X  

DDAVP Rhinal Tube (desmopressin acetate)

X     X  
DDAVP Tablets (desmopressin acetate) X     X  
Norvir (ritonavir capsules) Soft Gelatin & (ritonavir oral solution) X   X X  

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Strattera (atomoxetine hydrochloride) Capsules   X X X  
Tracleer (bosentan) Film-coated Tablets   

X

X X X
Xyrem (sodium oxybate) Oral Solution   X X X  

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Agenerase (amprenavir) Oral Solution      X X  
Aranesp (darbepoetin alfa) for Injection     X   X
Effexor XR (venlafaxine hydrochloride) Extended-Release Capsules      X X X
Mevacor (lovastatin) Tablets     X X  
NovoSeven Coagulation Factor VIIa (Recombinant)     X   X
Ortho Evra (norelgestromin /ethinyl estradiol transdermal system)      X    
Tarceva (erlotinib) Tablets      X    

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Amaryl (glimepiride tablets)        X X
Aredia (pamidronate disodium for injection) for Intravenous Infusion        X  

Avelox (moxifloxacin hydrochloride) Tablets

Avelox I.V. (moxifloxacin hydrochloride in sodium chloride injection)  

      X  X
Bicillin C-R (penicillin G benzathine and penicillin G procaine injectable suspension) Disposable Syringe 4 mL for deep IM injection only        X  
Bicillin C-R (penicillin G benzathine and penicillin G procaine injectable suspension) Tubex 1 mL and 2 mL for deep IM injection only        X  
Bicillin C-R 900/300 (penicillin G benzathine and penicillin G procaine injectable suspension) Tubex 2 mL for deep IM Injection only        X  
Bicillin L-A (penicillin G benzathine injectable suspension) Disposable Syringe for deep IM injection only        X  
Bicillin L-A (penicillin G benzathine injectable suspension) Tubex 1 mL and 2 mL for deep IM injection only        X  
Derma-Smoothe/FS (fluocinolone acetonide) Topical Oil, 0.01%        X  X
Effexor XR (venlafaxine hydrochloride) Extended-Release Capsules        X  
Fosamax (alendronate sodium) Tablets and Oral Solution        X
Fosamax Plus D (alendronate sodium/cholecalciferol) Tablets        X X
Hiprex (methenamine hippurate tablets, USP)       X  
Ketek (telithromycin) Tablets        X X
Kytril (granisetron hydrochloride) Injection        X  
Kytril (granisetron hydrochloride) Tablets and Oral Solution        X  
Lamisil (terbinafine hydrochloride tablets)       X X
Lexiva (fosamprenavir calcium) Tablets        X  
Neutrexin (trimetrexate glucuronate for injection)       X  

Pamidronate Disodium Injection 

Pamidronate Disodium for Injection  

      X  
Parlodel SnapTabs (bromocriptine mesylate) Tablets and Capsules       X X
PEG-Intron (peginterferon alfa-2b) Powder for Injection       X  
Pletal (cilostazol) Tablets       X  
Revatio (sildenafil citrate) Tablets       X X
Singulair (montelukast sodium) Tablets, Chewable Tablets, and Oral Granules       X X
Valtrex (valacyclovir hydrochloride) Caplets       X  

Zyvox (linezolid) Tablets and Injection

Zyvox (linezolid) for Oral Suspension 

      X  

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Angiomax (bivalirudin)         X
Avalide (irbesartan-hydrochlorothiazide) Tablets         X
Avapro (irbesartan) Tablets         X