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Summary View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- January 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
Combipatch (estradiol/norethindrone acetate transdermal system)
 X
 X      
Phenergan (promethazine hydrochloride) Tablets and Suppositories
X
   X    

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Anafranil (clomipramine hydrochloride capsules)
 
X X X  
Aventyl (nortriptyline hydrochloride) Oral Solution
 

X

X X  
Desyrel (trazodone hydrochloride) Tablets
 
X X X  
Doxil (doxorubicin HCl liposome injection)
 
X X X X
Femhrt (norethindrone acetate/ethinyl estradiol tablets)
 
X X X X
Limbitrol (chlordiazepoxide and amitriptyline hydrochloride) Tablets
 
X X X  
Marplan (isocarboxazid) Tablets
 
X X X  
Norpramin (desipramine hydrochloride) Tablets
 
X X X  
Pamelor (nortriptyline HCl) Capsules and  Solution
 
X X X  
Parnate (tranylcypromine sulfate) Tablets
 
X X X  
Paxil (paroxetine hydrochloride)  Controlled-Release Tablets 
 
X X X  
Paxil (paroxetine hydrochloride) Tablets
 
X X X  
Pexeva [paroxetine (as mesylate)] Tablets
 
X X X  
Remeron SolTab (mirtazapine) Orally Disintegrating Tablets 
 
X X X  
Remeron (mirtazapine) Tablets
 
X X X  
Serzone (nefazodone hydrochloride) Tablets
 
X X X  
Surmontil (trimipramine maleate) Capsules
 
X X X  
Tofranil-PM (imipramine pamoate)  Capsules
 
X X X  
Wellbutrin (bupropion hydrochloride) Tablets
 
X X X  
Wellbutrin SR (bupropion hydrochloride) Sustained-Release Tablets  
 
X X X  
Wellbutrin XL (bupropion hydrochloride extended-release tablets) 
 
X X X  
Zyban (bupropion hydrochloride) Sustained-Release Tablets
 
X X X  

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Aranesp (darbepoetine alfa)
 
  X X  
Avastin (bevacizumab)
 
  X X X
Intron A (interferon alfa-2b, recombinant) For Injection
 
  X X  
Novamine 15% Amino Acid Injection Pharmacy Bulk Package 
 
  X X  
Zometa (zoledronic acid) Injection
 
  X X  

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Ancef (cefazolin for injection)
 
    X  
Avandia (rosiglitazone maleate) Tablets
 
    X  X
Avandamet (rosiglitazone maleate and metformin hydrochloride) Tablets
 
    X  X
Dopamine Hydrochloride in 5% Dextrose Injection, USP 
 
    X  
Magnevist (brand of gadopentetate dimeglumine) Injection
 
    X  
PEG-Intron (peginterferon alfa-2b) Powder for Injection   
    X  
Zevalin (ibritumomab tiuxetan)
 
    X  

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
 
       X
 
       X
 
       X
  
      X
 
       X