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Summary View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- April 2006

 

The summary view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, 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: BW=BOXED WARNING, C=CONTRAINDICATIONS, W=WARNINGS, P=PRECAUTIONS, AR=ADVERSE REACTIONS

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

BW

C

W

P

AR

Premarin (conjugated estrogens tablets, USP) X   X X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

Prozac (fluoxetine hydrochloride)   X   X X
Sarafam (fluoxetine hydrochloride)  

X

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

BW

C

W

P

AR

Advil (200 mg ibuprofen) Capsules and Tablets     X    
Advil Cold & Sinus Liqui-Gels (200 mg ibuprofen/30 mg pseudoephedrine HCl capsules)     X    
Advil Cold & Sinus (200 mg ibuprofen/ 30 mg pseudoephedrine HCl) Tablets     X    
Avandamet (rosiglitazone maleate/metformin HCl)     X    
Avandia (rosiglitazone maleate) Tablets     X    
Avastin (bevacizumab) for Intravenous Use     X    
Children's Advil Cold (100 mg/5 ml ibuprofen and 15 mg/5 ml pseudoephedrine) Suspension     X    
Children's Advil Allergy Sinus (100 mg ibuprofen, 15 mg pseudoephedrine, and 1mg chlorpheniramine per 5 mL) Suspension     X    
Children's Advil Chewables (50 mg ibuprofen) Chewable Tablet

Junior Strength Advil Chewables (100 mg ibuprofen) Chewable Tablet

    X    
Infant's Advil (50 mg ibuprofen/1.25 mL) Concentrated Drops     X    
Focalin XR (dexmethylphenidate HCl) Extended-Release Capsules     X    
Lidoderm (lidocaine 5%) Patch     X   X

Razadyne (galantamine HBr) Extended-Release Capsules

Razadyne (galantaine HBr) Tablets and Oral Solution

    X X X
Synarel (nafarelin acetate) Nasal Solution     X X X
(Click on drug name to go to detailed view)

BW

C

W

P

AR

Catapres-TTS (clonidine) Transdermal Therapeutic System       X  
Cosopt (dorzolomide hydrochloride-timolol maleate ophthalmic solution) Sterile Ophthalmic Solution       X  
Desoxyn (methamphetamine HCl tablets, USP)       X  
Emla (lidocaine 2.5% and prilocaine 2.5%) Cream       X  
Gemzar (gemcitabine HCl) for Injection       X X
Genotropin (somatropin [rDNA origin] for injection)       X X
Hyzaar (losartan potassium-hydrochlorothiazide tablets)       X  
Klor-Con (potassium chloride extended-release tablets, USP)       X X

Lescol (fluvastatin sodium) Capsules

Lescol XL (fluvastatin sodium) Extended-Release Tablets

      X X
Nexium (esomeprazole magnesium) Delayed-Release Capsules       X X

Prevacid (lansoprazole) Delayed-Release Capsules

Prevacid (lansoprazole) for Delayed-Release Oral Suspension

Prevacid SoluTab (lansoprazole) Delayed-Release Orally Disintegrating Tablets

      X  
Prevacid NapraPAC (lansoprazole delayed-release capsules and naproxen tablets kit), 15 mg /250 mg, 15 mg/375 mg, and 15 mg/500 mg       X  

Prograf (tacrolimus) Capsules

Prograf (tacrolimus) Injection (for intravenous infusion only)

      X  

Rescriptor (delavirdine mesylate) Oral Tablets

      X  
Revex (nalmefene hydrochloride injection)       X  
Timoptic (timolol maleate ophthalmic solution) Sterile Ophthalmic Solution       X  
Timoptic-XE (timolol maleate ophthalmic gel forming solution) Sterile Ophthalmic Gel Forming Solution       X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

Avalide (irbesartan-hydrochlorothiazide) Tablets

        X

Avapro (irbesartan) Tablets

        X
Caduet (amlodipine besylate/atorvastatin calcium) Tablets         X
Hepsera (adefovir dipivoxil) Tablets         X
Namenda (memantine hydrochloride) Tablets and Oral Solution         X

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