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Summary View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- January 2006

 

The summary view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, 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)

BW

C

W

P

AR

Anaprox /Anaprox DS (naproxen sodium tablets) X X X X  
Ansaid (flurbiprofen tablets, USP) X X X X  
Arthrotec (diclofenac sodium/misoprostol) Tablets X X X X  
Cataflam (diclofenac potassium immediate-release tablets) X X X X  
Clinoril (sulindac) Tablets X X X X  
Daypro (oxaprozin) Caplets X X X X  
Daypro Alta (oxaprozin potassium) Tablets X X X X  
Depacon (valproate sodium injection) X     X  
Depakene (valproic acid capsules and syrup) X     X  
Depakote (divalproex sodium coated particles in capsules) Sprinkle Capsules X     X  
Dolobid (diflunisal) Tablets X X X X  
Elidel (pimecrolimus) Cream 1% X   X    
Feldene (piroxicam) Capsules X X X X  
Indocin (indomethacin) Capsules, Oral Suspension, and Suppositories X X X X  
Lodine (etodolac capsules and tablets) X X X X  
Lodine XL (etodolac extended-release tablets) X X X X  
Motrin (ibuprofen) Suspension 100 mg/5 mL X X X X  
Motrin (ibuprofen tablets, USP) X X X X  
Nalfon (fenoprofen calcium capsules, USP) X X X X  
Naprelan (naproxen sodium) Controlled-Release Tablets X X X X  
Naprosyn (naproxen tablets)

Naprosyn (naproxen suspension)

EC-Naprosyn (naproxen delayed-release tablets)

X X X X  
Nimotop (nimodipine) Capsules For Oral Use X   X X  
Orudis (ketoprofen) Capsules

Oruvail (ketoprofen) Extended-Release Capsules)

X X X X  
Ponstel (mefenamic acid capsules, USP) X X X X  
Protopic (tacrolimus) Ointment, 0.03% and 0.1% X   X    
Relafen (nabumetone) Tablets X X X X  
Voltaren (diclofenac sodium enteric-coated tablets) X X X X  
Voltaren-XR (diclofenac sodium extended-release tablets) X X X X  

(Click on drug name to go to detailed view)

BW
C
W
P
AR
Parnate (tranylcypromine sulfate tablets)   X      

(Click on drug name to go to detailed view)

BW 
C
W
P
AR
Aleve (220 mg naproxen sodium) Tablets     X    
Aleve Cold & Sinus (220 mg naproxen sodium and 120 mg pseudoephedrine HCl) Extended Release Tablets     X    
Aleve Sinus & Headache (220 mg naproxen sodium and 120 mg pseudoephedrine HCl) Extended Release Tablets     X    
Carbatrol (carbamazepine) Extended-Release Capsules     X X  
Children's ElixSure IB (100 mg/5 mL ibuprofen) Suspension     X    
Junior Strength Advil (100 mg ibuprofen) Tablets     X    
Effexor (venlafaxine hydrochloride) Tablets     X    
Effexor XR (venlafaxine hydrochloride) Extended-Release Capsules     X    
Midol Extended Relief (220 mg naproxen sodium) Tablets     X    

(Click on drug name to go to detailed view)

BW
C
W
P
AR
Amoxil (amoxicillin capsules, tablets, chewable tablets, and powder for oral suspension)       X  
Coly-Mycin M Parenteral (colistimethate for injection, USP)       X  
Crixivan (indinavir sulfate) Capsules       X  
Depakote (divalproex sodium delayed release tablets) Tablets       X  
Depakote ER (divalproex sodium extended-release tablets)       X  
Didronel (etidronate disodium) Tablets       X  
Eryc (erythromycin delayed-release capsules, USP)       X  
Floxin (ofloxacin tablets) Tablets       X  
Keppra (levetiracetam) Tablets and Oral Solution       X  
Levaquin (levofloxacin) Tablets, Oral Solution, and Injection

Levaquin (levofloxacin in 5% dextrose) Injection

      X  
Miacalcin (calcitonin-salmon) Nasal Spray       X  
Prilosec (omeprazole) Delayed-Release Capsules       X  
Proloprim (trimethoprim) Tablets       X  
Reyataz (atazanavir sulfate) Capsules       X  
Stromectol (ivermectin) Tablets       X X

(Click on drug name to go to detailed view)

BW 
C
W
P
AR

Actonel (risedronate sodium tablets)

        X

Actonel with Calcium (risedronate sodium tablets with calcium carbonate tablets, USP)

        X

Aristopan (triamcinolone hexacetonide injectabale suspension, USP) 5 mg/mL, Parenteral

        X

Aristopan (triamcinolone hexacetonide injectabale suspension, USP) 20 mg/mL, Parenteral

        X

Mylotarg (gemtuzumab ozogamicin for injection)

        X

Nexium I.V. (esomeprazole sodium) for Injection

        X

Zetia (ezetimibe) Tablets

        X