Home : Unsafe Drugs : Yasmin : FDA Information : October 2006 Monthly Safety Labeling

October 2006 Monthly Safety Labeling

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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
Avastin (bevacizumab) for Intravenous Use X   X X X  
ChloraPrep with Tint (2% chlorhexidine gluconate (w/v) topical solution) 26-mL Applicator X   X      
Coumadin Tablets (warfarin sodium tablets, USP) Crystalline

Coumadin for Injection (warfarin sodium for injection, USP)

 X     X X MG
Remicade (infliximab) for IV Injection X X X X X MG
Seroquel (quetiapine fumarate) Tablets X   X X X MG
(Click on drug name to go to detailed view)

BW

C

W

P

AR

 PPI/MG
Allegra (fexofenadine hydrochloride) Tablets and Oral Suspension   X   X X  
Opana (oxymorphone hydrochloride) Injection  

X

 X X X  
0.9% Sodium Chloride Irrigation, USP   X X X X  
Vicoprofen (hydrocodone bitartrate and ibuprofen tablets)   X X X   MG
(Click on drug name to go to detailed view)

BW

C

W

P

AR

 PPI/MG
Depacon (valproate sodium injection)     X      
Depakene (valproic acid capsules and oral solution, USP)     X      
Depakote (divalproex sodium) Delayed-Release Tablets     X      
Depakote ER (divalproex sodium) Extended-Release Tablets     X      
Depakote (divalproex sodium coated particles in capsules) Sprinkle Capsules     X      
Heparin Sodium Injection, USP     X X X  
Hep-Lock (heparin lock flush solution, USP)     X X X  
Hep-Lock U/P Preservative-Free (heparin lock flush solution, USP)     X X X  
Strattera (atomoxetine HCl) Capsules     X     MG
Taxotere  (docetaxel) Injection Concentrate     X X X PPI
Vytorin (ezetimibe/simvastatin tablets)     X X X PPI
(Click on drug name to go to detailed view)

BW

C

W

P

AR

 PPI/MG
Abilify (aripiprazole) Tablets and Oral Solution

Abilify Discmelt (aripiprazole) Orally Disintegrating Tablets

       X    
Avandaryl (rosiglitazone maleate and glimepiride) Tablets       X X PPI
Byetta (exenatide injection)       X X PPI
Cubicin (daptomycin for injection)       X    
Factive (gemifloxacin mesylate) Tablets       X   PPI
Ferrlecit (sodium ferric gluconate complex in sucrose injection)       X X  
Flovent HFA (fluticasone propionate) Inhalation Aerosol       X   PPI
Gleevec (imatinib mesylate) Tablets       X X  
Gleevec (imatinib mesylate) Tablets       X    
Namenda (memantine hydrochloride) Tablets and Oral Solution       X    
Neulasta (pegfilgrastim)       X   PPI
Neupogen (filgrastim)       X   PPI

Nexium (esomeprazole magnesium) Delayed-Release Capsules

Nexium (esomeprazole magnesium) for Delayed-Release Oral Suspension

       X    
Prinivil (lisinopril) Tablets       X    
Prinzide (lisinopril/hydrochlorothiazide) Tablets        X    
Risperdal Consta (risperidone) Long Acting Injection       X    

Risperdal (risperidone) Tablets and Oral Solution

Risperdal M-TAB (risperidone) Orally Disintegrating Tablets

       X    
Viagra (sildenafil citrate) Tablets       X    
(Click on drug name to go to detailed view)

BW

C

W

P

AR

 PPI/MG
Aricept (donepezil hydrochloride) Oral Solution         X  

Aricept (donepezil hydrochloride tablets)

Aricept ODT (donepezil hydrochloride) Orally Disintegrating Tablets

         X  
Cialis (tadalafil) Tablets         X  
Hepsera (adefovir dipivoxil) Tablets         X PPI
Rapamune (sirolimus) Oral Solution and Tablets         X  
Yaz (drospirenone and ethinyl estradiol) Tablets         X PPI
(Click on drug name to go to detailed view)

BW

C

W

P

AR

 PPI/MG
Humatrope (somatropin [rDNA origin] for Injection)           PPI
Intron A (interferon alfa-2b, recombinant) for Injection           MG

Topamax (topiramate) Tablets

Topamax (topiramate capsules) Sprinkle Capsules

          PPI

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