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

Arixtra (fondaparinux sodium) Injection X   X X X
Cordarone (amiodarone HCl) Tablets X   X X X
Robaxin Injectable (methacarbamol injection, USP) X   X X X

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Viramune (nevirapine) Tablets and Oral Suspension   X X X X

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Angiomax (bivalirudin) for Injection     X X X
Avandamet (rosiglitazone maleate and metformin HCl) Tablets     X X  
Campath (alemtuzumab)     X    
Capoten (captopril) Tablets     X    
Celexa (citalopram hydrobromide) and Oral Solution     X X  
Crixivan (indinavir sulfate) Capsules     X X  
Decadron (dexamethasone tablets, USP)     X X X
Duramorph (morphine sulfate injection)      X   X
Effexor (venlafaxine hydrochloride) Tablets     X X  
Effexor XR (venlafaxine hydrochloride) Extended Release Capsules     X X  
8.5% FreAmine III (amino acid injection)     X X  
10% FreAmine III (amino acid injections)     X X  
3% FreAmine III (amino acid injection) with Electrolytes     X X  
8.5% FreAmine III (amino acid injection) with Electrolytes     X X  
6.9% FreAmine HBC (amino acid injection)     X X  
Infumorph (preservative-free morphine sulfate sterile solution)     X   X
Lexapro (escitalopram oxalate) Tablets and  Oral Solution     X X  
5.4% NephrAmine (essential amino acid injection)     X X  
Neumega (oprelvekin)     X   X
Paxil (paroxetine hydrochloride) Tablets and Oral Suspension     X X  
Paxil (paroxetine hydrochloride) Controlled Release Tablets     X X  
Serzone (nefazodone hydrochloride) Tablets     X X  
Taxotere (docetaxel) for Injection Concentrate     X X X
Twinject (epinephrine) Auto-Injector     X X  
Wellbutrin (bupropion hydrochloride) Tablets     X X  
Wellbutrin SR (bupropion hydrochloride) Sustained-Release Tablets     X X  
Wellbutrin XL (bupropion hydrochloride extended-release tablets)     X X  

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Aricept (donepezil hydrochloride tablets)       X  
Avandia (rosiglitazone maleate) Tablets       X  
Brevital Sodium (methohexital sodium for injection)       X  
Cantil (mepenzolate bromide USP) Tablets       X  
Combivir (lamivudine/zidovudine) Tablets       X X
Copegus (ribavirin, USP) Tablets       X  
Estraderm (estradiol transdermal system)       X  

Fortaz (ceftazidime for injection)

Fortaz (ceftazidime injection)

      X  
Invanz (ertapenem for injection)       X  
Iressa (gefitinib tablets)       X  
Klor-Con (potassium chloride) Extended-Release 8 & 10 mEq Tablets       X  
Metopirone (metyrapone USP) Capsules       X  
Minocin (minocycline for injection) Intravenous       X X
Minocin (minocycline hydrochloride) Oral Suspension       X X
Minocin (minocycline hydrochloride) Pellet-filled Capsules       X X
Primaxin I.M. Injectable (imipenem and cilastatin for injectable suspension)       X  
Primaxin I.V. (imipenem and cilastatin for Injection)       X  
Prinivil (lisinopril) Tablets       X  
Protonix (pantoprazole sodium) Delayed-Release Tablets       X  
Protonix I.V. (pantoprazole sodium) for Injection       X  
Relpax (eletriptan) Tablets       X  

Ritalin (methylphenidate HCl tablets)

Ritalin SR (methylphenidate HCl sustained- release tablets)

      X  
Vancocin (vancomycin hydrochloride capsules, USP) Pulvules       X  
Velcade (bortezomib) for Injection       X X
Verelan PM capsules (verapamil hydrochloride) Extended-Release Capsules Controlled-Onset       X  

Zinacef (cefuroxime for injection)

Zinacef (cefuroxime injection)

      X  

(Click on drug name to go to detailed view)

C 
BW
W
P
AR

Augmentin (amoxicillin/clavulanate potassium) Tablets

        X

Augmentin XR (amoxicillin/clavulanate potassium) Extended Release Tablets

        X
Enbrel (etanercept)         X
Gemzar (gemcitabine HCl) for Injection         X
Lactated Ringer's and 5% Dextrose Injection, USP         X
Lovenox (enoxaparin sodium injection)         X
Zovirax (acyclovir) Capsules, Tablets, and Suspension         X
Zovirax (acyclovir sodium) for Injection         X