Home : Unsafe Drugs : Bisphosphonates : FDA Information : December 2006 Monthly Safety Labeling

December 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
Activella (estradiol/norethindrone acetate) Tablets X   X X X PPI
Diskets Dispersible Tablets (methadone hydrochloride tablets, USP) X  X X X X  
Trasylol (aprotinin injection) X X X X X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

 PPI/MG
Crixivan (indinavir sulfate) Capsules   X   X   PPI
Vfend I.V. (voriconazole) for Injection

Vfend (voriconazole) Tablets

Vfend (voriconazole) for Oral Suspension

  

X

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

BW

C

W

P

AR

 PPI/MG
Colazal (balsalazide disodium) Capsules     X X X PPI
Emtriva (emtricitabine) Capsules and Oral Solution     X X X PPI
Ibuprofen Capsules, 200 mg     X      
Pexeva (paroxetine mesylate) Tablets     X X X  
Suprane (desflurane, USP) Volatile Liquid for Inhalation     X X X  
Twinject Auto-Injector (epinephrine injection, USP 1:1000)     X     PPI
(Click on drug name to go to detailed view)

BW

C

W

P

AR

 PPI/MG
Byetta (exenatide) Injection       X X PPI
Celebrex (celecoxib) Capsules       X X  
Clarinex (desloratadine) Tablets, Syrup, and RediTabs Tablets       X X  
Dostinex (cabergoline) Tablets       X X  
Equetro (carbamazepine) Extended-Release Capsules       X    
Fuzeon (enfuvirtide) for Injection       X X PPI
Inderal (propranolol hydrochloride) Tablets       X    
Inderide (propranolol hydrochloride and hydrochlorothiazide) Tablets       X    
Kaletra (lopinavir/ritonavir) Capsules and Oral Solution       X   PPI
Kaletra (lopinavir/ritonavir) Tablets and Oral Solution       X   PPI
Kineret (anakinra)        X    
Singulair (montelukast sodium) Tablets, Chewable Tablets, and Oral Granules       X    
Velcade (bortezomib) for Injection       X X PPI
Viracept (nelfinavir mesylate) Tablets and Oral Powder       X   PPI
(Click on drug name to go to detailed view)

BW

C

W

P

AR

 PPI/MG
Evoxac (cevimeline hydrochloride) Capsules         X  
Fosamax (alendronate sodium) Tablets and Oral Solution         X  
Fosamax Plus D (alendronate sodium/cholecalciferol) Tablets         X PPI
Gliadel Wafer (polifeprosan 20 with carmustine implant)         X PPI
Santura (trospium chloride) Tablets         X  
Spiriva HandiHaler (tiotropium bromide inhalation powder) for Oral Inhalation Only         X PPI
(Click on drug name to go to detailed view)

BW

C

W

P

AR

 PPI/MG
Depakote Sprinkle Capsules (divalproex sodium coated particles in capsules)           PPI
Hyzaar (losartan potassium-hydrochlorothiazide tablets)           PPI
PegIntron (peginterferon alfa-2b) Powder for Injection           MG
PegIntron (peginterferon alfa-2b) Redipen Single Dose Delivery System           MG

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