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U.S. Department of Health and Human Services

Safety

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November 2013

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

Prevpac (Lansoprazole 30 mg delayed-release, Amoxicillin 500 mg capsules and Clarithromycin 500 mg tablets)

 XX X 
Zestoretic (Lisinopril/Hydrochlorothiazide) Tablets X  X 
Zestril (Lisinopril) Tablets X  X 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Amturnide (Aliskiren, Amlodipine and Hydrochlorothiazide) Tablets   XX  
Aralen (Chloroquine Phosphate) Tablets   X X 
Jakafi (Ruxolitinib) Tablets   X   
Lysodren (Mitotane) Tablets  X 
Nexavar (Sorafenib) Tablets   X   
Noxafil (Posaconazole) Delayed-release tablets and Oral Suspension   X   
Onfi (Clobazam) Tablets and Oral Suspension   XX  
Remicade (Infliximab) Lyophilized Concentrate for Injection
 
  XX  
Revlimid (Lenalidomide) Capsules  XX MG
Simponi (Golimumab) Injection  XXX 
Tekamlo (Aliskiren and Amlodipine) Tablets  XX  
Tekturna (Aliskiren) Tablets  XX  
Tekturna HCT (Aliskiren and Hydrochlorothiazide) Tablets  XX  
Xalkori (Crizotinib) Capsules   XX  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Actoplus Met XR (Pioglitazone Hydrochloride and Metformin Hydrochloride)   X  
Actos (Pioglitazone) Tablets    X  
Caduet (Atorvastatin/Amlodipine) Tablets    X  
Duetact (Pioglitazone Hydrochloride) Tablet    X  
Fosamax Plus D (Alendronate Sodium/Cholecalciferol) Tablets    XX 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Cubicin (Daptomycin) for Injection     
X
 
Furadantin (Nitrofurantoin) Oral Suspension     
X
 
Somatuline Depot (Lanreotide) Injection     
X
 
Votrient (Pazopanib Hydrochloride) Tablets     X 
Xyzal (Levocetirizine Dihydrochloride) Tablets and Oral Solution    X