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Summary View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- July 2005

 

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

Arthrotec (diclofenac sodium/misoprostol) Tablets X      X  
Celebrex (celecoxib capsules) X  X  X X X
NuvaRing (etonogestrel/ethinyl estradiol vaginal ring) X    X  X  
Pipracil (piperacillin sodium) X     X X
Pravachol (pravastatin sodium) Tablets X    X    X

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Mifeprex (mifepristone) Tablets   X X    

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Enbrel (etanercept) For Subcutaneous Injection     X X X
Flovent Diskus (fluticasone propionate inhalation powder)     X X X
Neoral  Soft Gelatin Capsules (cyclosporine capsules, USP) Modified

Neoral  Oral Solution (cyclosporine oral solution, USP) Modified

    X X  
Norplant System (levonorgestrel implants)     X    
Reytaz (atazanavir sulfate) Capsules     X X  

Sandimmune Soft Gelatin Capsules (cyclosporine capsules, USP)

Sandimmune Oral Solution (cyclosporine oral solution, USP)

Sandimmune  Injection (cyclosporine injection, USP) FOR INFUSION ONLY

    X X  

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Adderall XR (mixed salts of a single-entity amphetamine product) Extended-Release Capsules       X  X
Avandia (rosiglitazone maleate) Tablets       X  X
Camptosar (irinotecan hydrochloride injection)       X X
Cialis (tadalafil) Tablets       X  X
Levitra (vardenafil hydrochloride) Tablets       X  X
Meridia (sibutramine hydrochloride monohydrate) Capsules       X  
Norvasc (amlodipine besylate) Tablets       X  
Paxil (paroxetine hydrochloride) Tablets and Oral Suspension       X  
Paxil (paroxetine hydrochloride) Controlled-Release Tablets        X  
Precose (acarbose tablets)        X X
Renagel (sevelamer hydrochloride) Tablets       X  
Septra (trimethoprim/sulfamethoxazole) Tablets

Septra (trimethoprim/sulfamethoxazole) DS Tablets

Septra (trimethoprim/sulfamethoxazole) Suspension

Septra (trimethoprim/sulfamethoxazole) Grape Suspension

      X  
Singulair (montelukast sodium) Tablets, Chewable Tablets, and Oral Granules       X  X
Viagra (sildenafil citrate) Tablets       X X

(Click on drug name to go to detailed view)

C 
BW
W
P
AR

Adenocard IV (adenosine injection) 

        X

Adenoscan (adenosine injection) 

        X

Benicar (olmesartan medoxomil) Tablets

        X

Benicar HCT (olmesartan medoxomil-hydrochlorothiazide) Tablets

        X

Omnicef (cefdinir) Capsules

Omnicef (cefdinir) Powder for Oral Suspension

        X

Vfend (voriconazole) Tablets

Vfend  I.V. (voriconazole) for Injection

Vfend (voriconazole) for Oral Suspension

        X