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Summary View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- August 2007

 

The summary view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE 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 BOXED WARNING, CONTRAINDICATIONS, or WARNINGS sections, and a link to the revised prescribing information.

Key to Label Section Acronyms:

BW=BOXED WARNING, C=CONTRAINDICATIONS, W=WARNINGS, P=PRECAUTIONS
AR=ADVERSE REACTIONS, PPI/MG=PATIENT PACKAGE INSERT/MEDICATION GUIDE

 
DRUG NAME
SECTIONS MODIFIED
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Actos (pioglitazone hydrochloride) Tablets
X
X
X
X
 
 
Avandamet (rosiglitazone maleate and metformin hydrochloride) Tablets
X
X
X
 
 
 
Avandaryl (rosiglitazone maleate and glimepiride) Tablets
X
X
X
 
 
 
Avandia (rosiglitazone maleate) Tablets
X
X
X
 
 
 
Celexa (citalopram hydrobromide) Tablets and Oral Solution
X
 
X
X
  MG
Cymbalta (duloxetine hydrochloride) Delayed-Release Capsules
X
 
X
X
  MG
Diovan (valsartan) Tablets
X
 
X
X
   
Effexor (venlafaxine hydrochloride) Tablets
X
 
X
X
  MG
Effexor XR (venlafaxine hydrochloride) Extended-Release Capsules
X
 
X
X
  MG
Lexapro (escitalopram oxalate) Tablets and Oral Solution
X
 
X
X
  MG
Limbitrol (chlordiazepoxide) (amitriptyline HCI) DS (double strength) Tablets
X
 
X
X
  MG
Marplan (isocarboxazid) Tablets
X
 
X
X
  MG
Nardil (phenelzine sulfate tablets, USP)
X
 
X
X
  MG
Parnate (tranylcypromine sulfate) Tablets
X
 
X
X
  MG
Paxil (paroxetine hydrochloride) Tablets and Oral Suspension
X
 
X
X
  MG
Paxil CR (paroxetine hydrochloride) Controlled-Release Tablets
X
 
X
X
  MG
Pexeva (paroxetine mesylate) Tablets
X
 
X
X
  MG
Prozac (fluoxetine capsules, USP, fluoxetine oral solution, USP, fluoxetine delayed-release capsules, USP)
X
 
X
X
  MG
Sertraline Hydrochloride Tablets and Oral Concentrate
X
 
X
X
  MG
Sinequan (doxepin HCl) Capsules and Oral Concentrate
X
 
X
X
  MG
Surmontil (trimipramine maleate)
X
 
X
X
  MG
Symbyax (olanzapine and fluoxetine HCl capsules)
X
 
X
X
  MG
Tekturna (aliskiren) Tablets
X
 
X
X
   
Wellbutrin (bupropion hydrochloride) Tablets
X
 
X
X
  MG
Wellbutrin SR (bupropion hydrochloride) Sustained-Release Tablets
X
 
X
X
  MG
Wellbutrin XL (bupropion hydrochloride extended-release tablets)
X
 
X
X
  MG
Zyban (bupropion hydrochloride) Sustained-Release Tablets
X
 
X
X
  MG
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Reclast (zoledronic acid) Injection   X X X
X
PPI

Risperdal (risperidone) Tablets and Oral Solution

Risperdal M-TAB (risperidone) Orally Disintegrating Tablets

 

X

X X
X
 

Tegretol (carbamazepine, USP) Chewable Tablets and Suspension

Tegretol-XR (carbamazepine extended-release tablets)

  X X X
 
 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Albenza (albendazole) Tablets     X X
X
 

Ceftin Tablets (cefuroxime axetil tablets)

Ceftin for Oral Suspension (cefuroxime axetil powder for oral suspension)

    X X
 
 
NegGram Suspension (nalidixic acid, USP) Oral Suspension     X X
 
 

Neoral Soft Gelatin Capsules (cyclosporine capsules, USP) MODIFIED

Neoral Oral Solution (cyclosporine oral solution, USP) MODIFIED

    X X
 
 
Proquin XR (ciprofloxacin hydrochloride) Extended-Release Tablets     X X
 
PPI
Provigil (modafinil) Tablets     X X
 
PPI
Pulmicort Turbuhaler (budesonide inhalation powder) for Oral Inhalation Only     X X
X
PPI
Rituxan (rituximab)     X X
 
 
Trileptal (oxcarbazapine) Tablets and Oral Suspension     X X X  
Tykerb (lapatinib) Tablets     X X X  
Viramune (nevirapine) Tablets and Oral Suspension     X   X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Clinoril (sulindac) Tablets       X
X
MG

Coumadin Tablets (warfarin sodium tablets, USP) Crystalline

Coumadin for Injection (warfarin sodium for injection, USP)

      X
X
 
Diuril (chlorothiazide) Oral Suspension       X
 
 
Humalog (insulin lispro injection, USP [rDNA origin]), U-100       X
 
PPI
Humalog Mix 50/50 (50% insulin lispro protamine suspension and 50% insulin lispro injection [rDNA origin]), U-100       X
 
PPI
Humalog Mix 75/25 (75% insulin lispro protamine suspension and 25% insulin lispro injection [rDNA origin]), U-100       X
 
PPI
Mycamine (micafungin sodium) for Injection       X
 
 
Renagel (sevelamer hydrochloride) Tablets       X
X
 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Astelin (azelastine hydrochloride) Nasal Spray (for Intranasal Use Only)        
X
 
Elidel (pimecrolimus) Cream 1%        
X
 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Arthrotec (diclofenac sodium/misoprostol) Tablets
 
 
 
 
 
 
MG
Coreg CR (carvedilol phosphate) Extended Release Capsules
 
 
 
 
 
 
PPI
Humulin 50/50 (50% human insulin isophane suspension and 50% human insulin injection [rDNA origin]), U-100
 
 
 
 
 
 
PPI
Humulin 70/30 (70% human insulin isophane suspension and 30% human insulin injection [rDNA origin]), U-100
 
 
 
 
 
 
PPI
Humulin N NPH (human insulin [rDNA origin] isophane suspension), U-100          
PPI
Humulin R Regular (insulin human injection, USP [rDNA origin]), U-100          
PPI
Nalfon (fenoprofen calcium capsules, USP)          
MG

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