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

Alora (estradiol transdermal system) X  X X X
Arixtra (fondaparinux sodium) injection  X   X  X  X

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Atacand (candesartan cilexetil) Tablets      X X X
Cefuroxime for Injection USP and Dextrose Injection USP     X X  
Clozaril (clozapine) Tablets     X    
Lodine (etodolac capsules and tablets)     X X X
Midol Extended Relief (220 mg naproxen sodium)      X    
Pegasys (peginterferon alfa-2a)      X   X
Requip (ropinirole hydrochloride) Tablets     X X X
Tagamet HB (200mg cimitidine) Tablets     X    
Zestoretic (lisinopril/hydrochlorothiazide) Tablets     X    
Zestril (lisinopril) Tablets     X    
Zocor (simvastatin) Tablets     X X  

(Click on drug name to go to detailed view)

C 
BW
W
P
AR

0.45% Sodium Chloride Injection

0.9% Sodium Chloride Injection 

      X  
Actonel (risedronate sodium) Tablets        X X
Cefazolin for Injection USP and Dextrose Injection USP       X  X

Cipro (ciprofloxacin hydrochloride) Tablets

Cipro (ciprofloxacin) Oral Suspension

      X  X
Cipro XR (ciprofloxacin extended-release tablets)       X  X
Doryx (doxycycline hyclate) Delayed-Release Capsules       X  
DynaCirc (isradipine)  Capsules        X  X
Dynacirc CR (isradipine) Controlled-Release Tablets       X X
Gleevec (imatinib mesylate) Tablets       X  
Invanz (ertapenem for Injection)       X X
Leukeran (chlorambucil) Tablets       X  
Levitra (vardenafil hydrochloride) Tablets       X  
Lodine XL (etodolac extended-release tablets)        X X
Namenda (memantine hydrochloride) Tablets       X  
Ortho Tri-Cyclen (norgestimate/ethinyl estradiol) Tablets

Ortho-Cyclen (norgestimate/ethinyl estradiol) Tablets

      X  
Potassium Chloride in Sodium Chloride Injection        X  
Potassium Chloride in 5% Dextrose Injection       X  
Regranex (becaplermin) Gel 0.01%       X  
Remicade (infliximab) for IV Injection       X X
Reminyl (galantamine hydrobromide) Tablets, Oral Solution and Extended-Release Capsules       X  
Strattera (atomoxetine hydrochloride) Capsules       X  
Thallous Chloride Tl 201 (Thallous Chloride Tl 201 Injection)       X  
Viread (tenofovir disoproxil fumarate) Tablets       X X
Zinecard (dexrazoxane for injection)       X  
Zyvox (linezolid) Tablets, Injection and for Oral Suspension       X X

(Click on drug name to go to detailed view)

C 
BW
W
P
AR

Casodex (bicalutamide) Tablets

        X

Cipro (ciprofloxacin) I.V. for Intravenous Infusion

        X

Floxin Otic (Ofloxacin Otic) Solution 0.3%

        X

Lidoderm (lidocaine Patch 5%)

        X