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U.S. Department of Health and Human Services

Safety

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August 2010

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
Biltricide (praziquantel) tablets X 
Meridia (sibutramine hydrochloride) capsules X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG

Advil Allergy Sinus (ibuprofen 200 mg, chlorpheniramine maleate 2 mg, and pseudoephedrine 30 mg tablets) caplets

*Organ-Specific Warnings

  X   

Aleve (naproxen sodium) capsules

*Organ-Specific Warnings

  X   
Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate) tablets  X X X PPI

Childrens Advil Cold (ibuprofen 100mg and pseudoephedrine 15 mg/5 mL) oral suspension

*Organ-Specific Warnings

  X   
Cubicin (daptomycin) for injection  X  X 
Exelon Patch (rivastigmine) transdermal system  X X 
Flagyl (metronidazole) tablets, capsules, and Flagyl ER tablets   X    X  
Heparin Sodium in the 5% Dextrose injection and in the 0.9% Sodium Chloride injection     
Plavix (clopidogrel bisulfate) tablets  X  
Risperdal (risperidone) tablets, Risperdal (risperidone) oral solution, and Risperdal M-Tab (risperidone) oral disintegrating tablets  X X 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG

Amerge (naratriptan) tablets

*Serotonin Syndrome

   X PI 
Augmentin XR (amoxicillin/clavulanate potassium) extended release tablets   X  
Imitrex (sumatriptan) tablets   X PI 

Maxalt (rizatriptan benzoate) tablets and rapidisk tablets

*Serotonin Syndrome

   X  PI

Taxol (paclitaxel) for injection

   X 

Zomig (zolmitriptan) tablets and orally disintegrating tablets

*Serotonin Syndrome

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

BW

C

W

P

AR

PPI/MG
Lupron Depot - Ped (leuprolide acetate for depot suspension) Injection, Powder for Suspension    
X
 
Risperdal Consta (risperidone) long-acting injection    
X
 

Tekturna (aliskiren) tablets and Tekturna HCT (aliskiren/hydrochlorothiazide) tablets

    
X
 
Valturna (aliskiren/valsartan) combination tablets    
X
 
Xalatan (latanoprost) ophthalmic solution     X  
Zithromax (azithromycin) tablet, single-dose packet, IV for injection, and oral suspension    X