• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Safety

  • Print
  • Share
  • E-mail

November 2012

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

PCI=PATIENT COUNSELING INFORMATION

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

BW

C

W

P

AR

PPI/MG

Exforge (amlodipine/valsartan) Tablets

*Dual Blockade of the RAS

 X X  

Exforge HCT (amlodipine/valsartan/hydrochlorothiazide) Tablets

*Dual Blockade of the RAS

 X X  
Luvox (fluvoxamine) Tablets XX   
Luvox CR (fluvoxamine maleate) Extended-Release Capsules XX   
Norpramin (desipramine hydrochloride) Tablets  XX  MG
Oleptro (trazodone hydrochloride) Extended-Release Tablets  XX   
Twynsta (telmisartan/amlodipine) Tablets X X PI
Victrelis (boceprevir) Capsules XXXXPCI
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Acuvail (ketorolac tromethamine ophthalmic solution) 0.45%   XX  
Cimzia (certolizumab pegol)  XXX 
Cytotec (misoprostol) Tablets  XX  
Effient (prasugrel hydrochloride) Tablets  XX  
Hepsera (adefovir dipivoxil) Tablets  XX PI
Norvir (ritonavir) Soft Gelatin Capsules, Tablets and Oral Solution  XX PCI
PerioChip (chlorhexidine gluconate)  X   
Pradaxa (dabigatran etexilate mesylate) Capsules   XX  
Samsca (tolvaptan) Tablets  XXXMG
Uloric (febuxostat) Tablets   X   
Votrient (pazopanib) Tablets   XX  
Zegerid (omeprazole/sodium bicarbonate) Powder for Oral Suspension
Zegerid (omeprazole/sodium bicarbonate) Capsules
 
  XXX 
Zofran (ondansetron hydrochloride) Injection  XX  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Arava (leflunomide) Tablets    X 
Ditropan XL (oxybutynin chloride) Extended Release Tablets    X 
Metvixia (methyl aminolevulinate HCl) Cream    X 
NegGram (Nalidixic acid, USP) Caplet    X 
Nplate (romiplostim)     
X
 
Simponi (golimumab)    X 
Sutent (sunitinib malate) Capsules    X 
Zometa (zoledronic acid) Injection Single Dose Vial    X 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Amitiza (lubiprostone) Capsule      PCI