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U.S. Department of Health and Human Services

Safety

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May 2009

Drug Safety Labeling Changes

 

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

Advil

 

Advil (200 mg ibuprofen) tablets [OTC]

 

Advil Allergy Sinus (2mg clorpheniramine maleate, 200 mg ibuprofen, and 30 mg pseudoephedrine HCl) tablets [OTC]

 

Advil Cold & Sinus (200 mg ibuprofen and 30 mg pseudoephedrine HCl) tablets [OTC]

 

Advil Cold & Sinus Liqui-Gels (200 mg ibuprofen and 30 mg pseudoephedrine HCl) capsules [OTC]

 

Advil Liquigels (200 mg ibuprofen) capsules [OTC]

 

Advil PM (200 mg ibuprofen/ 38 mg diphenhydramine citrate)tablets [OTC]

 

Advil PM Liqui-Gels (200 mg ibuprofen/ 25 mg diphenhydramine HCl) capsules [OTC]

 

Children’s Advil (100 mg/ 5 mL ibuprofen) Suspension [OTC]

 

Children’s Advil Chewables (50 mg ibuprofen) chewable tablets [OTC]

 

Children’s Advil Cold (100 mg ibuprofen and 15mg/5ml pseudoephedrine HCl) suspension [OTC]

 

Infant’s Advil (50 mg ibuprofen/ 1.25 mL) Concentrated Drops [OTC]

 

Junior Strength Advil (100 mg ibuprofen) tablets [OTC]

    X      
Campath (alemtuzumab) Injection for intravenous use     X X X  
Coly-Mycin M Parenteral (colistimethate for Injection, USP)     X X    
Kerlone (betaxolol hydrochloride) 10 mg and 20 mg tablets     X X X  
Letairis (ambrisentan) 5 and 10 mg Tablets     X X   REMS/MG
Meridia (sibutramine hydrochloride monohydrate) 5, 10, and 15 mg Capsules     X   X  
(Click on drug name to go to detailed view) BW

C

W

P

AR

PPI/MG
Ancobon (flucytosine) 250 mg and 500 mg Capsules       X X  
Kepivance (palifermin)       X    
Plavix (clopidogrel bisulfate) 75 mg tablets       X    
Stromectol (ivermectin) 3 mg tablet       X    
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Claforan Sterile (cefotaxime for injection, USP) and Injection (cefotaxime injection, USP)        
X
 
Combivent Inhalation Aerosol (ipratropium bromide and albuterol sulfate) Inhalation Aerosol        
X
 
Lotrisone (clotrimazole and betamethasone dipropionate) Cream and Lotion        
X
PPI
PegIntron (peginterferon alfa-2b) Injection, Powder for Solution for Subcutaneous Use        
X
 
Uroxatral (alfuzosin HCl extended release tablets)        
X
 
Vectibix (panitumumab)        
X
 
Vyvanse (lisdexamfetamine dimesylate) 20mg, 30mg, 40mg, 50mg, 60mg, 70mg capsules         X  
Zestoretic (lisinopril and hydrochlorothiazide) tablets         X  
Zestril (lisinopril) tablets         X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Femring (estradiol acetate vaginal ring)           PPI
Prempro 0.3 mg/1.5 mg and 0.45 mg/1.5 mg(conjugated estrogens/medroxyprogesterone acetate tablets)           PPI
Tyzeka (telbivudine) 600 mg tablet           MG