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Summary View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- April 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
Enjuvia (synthetic conjugated estrogens, B) Tablets
X
 
 X
 
 
PPI
Fentora (fentanyl buccal tablet)
X
 
 
 
MG
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Ativan (lorazepam) Tablets  

X

X X
 
Femara (letrozole tablets)   X X  
X
 
Invirase (saquinavir mesylate) Capsules and Tablets   X X X
X
PPI
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Advicor (niacin extended-release/lovastatin tablets)     X X
 
 
Baraclude (entecavir) Tablets and Oral Solution     X  
 
PPI
Exjade (deferasirox) Tablets for Oral Suspension     X  
 X
 
Levitra (vardenafil HCl) Tablets     X X
 
PPI
Minocin (minocycline hydrochloride) Pellet-Filled Capsules     X X
 
 
Sarafem (fluoxetine hydrochloride tablets)       X X
 
 

Zerit (stavudine) Capsules

Zerit (stavudine) for Oral Solution 

    X X
 
PPI

Zyvox (linezolid) Injection and Tablets

Zyvox (Iinezolid) for Oral Suspension

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

BW

C

W

P

AR

PPI/MG
Actonel (risedronate sodium tablets)       X X PPI
Apidra (insulin glulisine [rDNA origin] injection)       X   PPI
Aranesp (darbepoetin alfa) for Injection       X   PPI
Asacol (mesalamine) Delayed Release Tablets       X X  
Avandamet (rosiglitazone maleate and metformin hydrochloride) Tablets       X X  
Avandia (rosiglitazone maleate) Tablets       X X  
Azmacort (triamcinolone acetonide) Inhalation Aerosol       X X  
BAL in Oil Ampules (dimercaprol injection, USP)       X    
IV Busulfex (busulfan) Injection       X
 
Carafate (sucralfate) Suspension       X
 
 
Carafate (sucralfate) Tablets       X
 
 
Cardizem LA (diltiazem hydrochloride) Extended Release Tablets       X
 
 
Focalin (dexmethylphenidate hydrochloride) Tablets       X
 
MG
Focalin XR (dexmethylphenidate hydrochloride) Extended-Release Capsules       X
 
MG
Fortamet (metformin hydrochloride) Extended-Release Tablets       X
 
PPI
Isoniazid Tablets, USP       X
 
 
Lantus (insulin glargine [rDNA origin] injection)       X
 
PPI
Mevacor (lovastatin) Tablets       X
 
 

Nexium (esomeprazole magnesium) Delayed-Release Capsules

Nexium (esomeprazole magnesium) for Delayed-Release Oral Suspension

      X
 
 
Nexium I.V. (esomeprazole sodium) for Injection       X
 
 
Potassium Chloride in 5% Dextrose and Sodium Chloride Injection, USP in Aviva Plastic Container       X
 
 
Prilosec (omeprazole) Delayed-Release Capsules       X
 
 
Remicade (infliximab) for IV Injection       X
 
 

Ritalin hydrochloride (methylphenidate hydrochloride tablets, USP)

Ritalin-SR (methylphenidate hydrochloride, USP sustained-release tablets)

      X
 
MG
Ritalin LA (methylphenidate hydrochloride) Extended-Release Capsules       X
 
MG
Singulair (montelukast sodium) Tablets, Chewable Tablets, and Oral Granules       X
 
PPI
Strattera (atomoxetine HCl) Capsules       X
MG
Symbyax (olanzapine and fluoxetine HCl capsules)       X
 
 
Tarceva (erlotinib) Tablets       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
Combivir (lamivudine/zidovudine) Tablets            
DepoCyt (cytarabine liposome injection) for Intrathecal Use Only         X  
Fosamax Plus D (alendronate sodium/cholecalciferol) Tablets         X PPI
Kaletra (lopinavir/ritonavir) Capsules and Oral Solution        
X
 
Kaletra (lopinavir/ritonavir) Tablets and Oral Solution        
X
 
Methergine (methylergonovine maleate) Tablets and Injection, USP        
X
 
Prialt (ziconotide intrathecal infusion)        
X
 
Rebetol (ribavirin, USP) Capsules and Oral Solution        
X
 
Solagé (mequinol 2%, tretinoin 0.01%) Topical Solution         
X
PPI
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG

EC-Naprosyn (naproxen delayed-release tablets)

Naprosyn (naproxen tablets)

Anaprox/Anaprox DS (naproxen sodium tablets)

Naprosyn (naproxen suspension)

 
 
 
 
 
 MG
NicoDerm CQ (nicotine transdermal system)
 
 
 
 
 
PPI 

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