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U.S. Department of Health and Human Services

Safety

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May 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

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

BW

C

W

P

AR

PPI/MG

Lotensin (benazepril) 

*Fetal Toxicity
X
  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Divigel (estradiol gel) XXX  

Focalin (dexmethylphenidate hydrochloride)

Focalin XR (dexmethylphenidate hydrochloride) 

 X  MG 
Gilenya (Fingolimod) XXXXMG
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
2% Chlorhexidine Gluconate (CHG) Cloth  X   
Aciphex (rabeprazole sodium) Delayed-Release Tablets  XX  
Actoplus Met (pioglitazone hydrochloride plus metformin hydrochloride) Tablets  XXXMG
Aredia (pamidronate disodium) for Injection   XXX 
Avagard Surgical and Healthcare Personnel Hand Antiseptic (chlorhexidine gluconate 1% solution and ethyl alcohol 61% w/w) Lotion  X   

Biaxin Filmtabs (clarithromycin tablets, USP)

Biaxin Granules (clarithromycin for oral suspension, USP)

Biaxin XL Filmtabs (clarithromycin extended release tablets) 

  X  
Catapres (clonidine hydrochloride) Tablets   X  
Catapres-TTS (clonidine) Transdermal Therapeutic System  XX  
Chlorascrub Swabsticks  X   
Dexilant (dexlansoprazole) delayed-release capsules  XX  
Folotyn (pralatrexate injection)  XXX 
Hibiclens (4% w/v chlorhexidine gluconate) solution  X   
Hibistat (0.5% chlorhexidine gluconate solution and 70% isopropyl alcohol w/w)  X   
Omeprazole/Sodium Bicarbonate/Magnesium Hydroxide Tablets     
Prevacid (lansoprazole) Delayed-Release Capsules
Prevacid (lansoprazole) Delayed-Release Orally Disintegrating Tablets
  XX  
Protonix (pantoprazole sodium) For Injection  XX  
Protonix (pantoprazole sodium) For Delayed-Release Oral Suspension
Protonix (pantoprazole sodium) Delayed-Release Tablets
  XX  
Scrub-Stat 2% and Scrub-Stat 4% (chlorhexidine gluconate 2% and 4%) Solutions  X   

Ultravist (brand of iopromide) Injection 

Ultravist (brand of iopromide) Injection Pharmacy Bulk Pack

  XXX 
Zarontin (ethosuximide) Capsules  XXX 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Cubicin (daptomycin for injection) Intravenous    X  
Effexor (venlafaxine HCl) Tablets
Effexor XR (venlafaxine HCl) Extended-Release Capsules
 
   X  
Ella (ulipristal acetate)    X  
Levemir (insulin detemir [rDNA origin]), Injection   XX 
Prolia (denosumab)    X MG
Stelara (ustekinumab) Injection   XX 
Tradjenta (linagliptin) Tablets    XX 
Venlafaxine HCl Extended-release Tablets   X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Amevive (alefacept)     
X
MG 
Avastin (bevacizumab)    X 
DuoNeb (albuterol sulfate and ipratropium bromide) Inhalation Solution    X 
Humira (adalimumab)    X 
Neupogen (filgrastim)    XPPI
Zestril (lisinopril) tablets     
X
 
Zestoretic (lisinopril/hydrochlorothiazide) tablets    X 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Dysport (abobotulinumtoxinA)      MG 
Revlimid (lenalidomide) Capsules      MG