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Summary View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- January 2004

 

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

Cenestin (synthetic conjugated estrogens, A) Tablets X X X X X
Climara (estradiol transdermal system) X X X X X

Clinimix - Sulfite Free
Clinimix E - Sulfite Free Injection

X     X  
Diabinese (chlorpropamide) Tablets X     X X
Femhrt (norethindrone acetate/ethinyl estradiol tablets) X X X X X
Vivelle (estradiol) X X X X X
Vivelle-Dot (estradiol) X X X X X

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Methotrexate Sodium for Injection
Methotrexate Sodium Injection
  X   X X

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Aggrenox (aspirin/extended-release dipyridamole) Capsules     X X  

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Ancef (cefazolin for injection)       X X
Aredia (pamidronate disodium injection)       X  
Celebrex (celecoxib) Capsules       X  

Cleocin HCl (clindamycin hydrochloride capsules)
Cleocin Phosphate Sterile Solution  (clindamycin injection)
Cleocin Phosphate IV Sterile Solution (clindamycin injection,
in 5% dextrose

      X  
Crixivan (indinavir sulfate) Capsules       X  
Eloxatin (oxaliplatin) for Injection       X X
Keflex (cephalexin) Pulvules       X  
Lamictal (lamotrigine) Tablets and Chewable Dispersible Tablets       X  
Lamisil (terbinafine hydrochloride tablets)       X X
Myleran (busulfan) Tablets       X  
Norvasc (amlodipine besylate) Tablets       X  
Oxistat (oxiconazole nitrate) Cream and Lotion       X  
Phenergan with dextromethorphan (promethazine HCl and dextromethorphan hydrobromide) Syrup       X  
Protonix (pantoprazole) Delayed-Release Tablets       X  
Proventil HFA (albuterol sulfate) Inhalation Aerosol       X  
Provigil (modafinil) Tablets       X X
Silvadene Cream (silver sulfadiazine cream)       X  
Tequin (gatifloxacin) Tablets and Injection       X X
 

Videx (didanosine) Chewable/Dispersible Tablets
Videx (didanosine) Buffered Powder for Oral Solution
Videx (didanosine) Pediatric Powder for Oral Solution
Videx (didanosine) Delayed-Release Capsules Enteric Coated Beadlets

 
      X  
Zithromax  IV (azithromycin for injection)       X X
Zithromax (azithromycin) for Oral Suspension and Tablets       X X
Zyvox IV (linezolid) Injection, Tablets and Oral Suspension        X  

(Click on drug name to go to detailed view)

C 
BW
W
P
AR

Clarinex (desloratadine) Tablets
Clarinex Reditabs (desloratadine rapidly disintegrating) Tablets

        X
Detrol (tolterodine tartrate) Tablets         X
Detrol LA (tolterodine tartrate) Extended Release Capsules         X
Emend (aprepitant) Capsules         X
Norplant System (levonorgestrel implants)         X
Paxil CR (paroxetine hydrochloride) Controlled-Release Tablets         X
Protonix I.V. (pantoprazole sodium) for Injection         X
Zomig and Zomig-ZMT (zolmitriptan) Tablets         X