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U.S. Department of Health and Human Services

Safety

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March 2012

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

Atacand HCT (candesartan cilextetil/hydrochlorothiazide) Tablets
 

*Fetal Toxicity

X XX  

Benicar (olmesartan medoxomil) Tablets

*Fetal Toxicity

X XX PCI
Sporanox (itraconazole) Oral Solution 
X
 

Twynsta (telmisartan/amlodipine) Tablets

*Fetal Toxicity

X XX PI

Zestoretic (lisinopril/hydrochlorothiazide) Tablets

*Fetal Toxicity

X XX  

Zestril (lisinopril) Tablets

*Fetal Toxicity

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

BW

C

W

P

AR

PPI/MG
Benlysta (belimumab)  XXX 
Celexa (citalopram hydrobromide) Tablets and Oral Solution 
 
  XX  
Enablex (darifenacin) Extended-Release Tablets   XX  
Incivek (telaprevir) Film-Coated Tablets  XX  
Janumet (sitagliptin and metformin fixed-dose combination) Tablets  XX  
Januvia (sitagliptin) Tablets  XX  
Kombiglyze XR (saxagliptin/metformin hydrochloride extended-release) Tablets  XX  
Lidocaine in 5% Dextrose Injection, USP  X  
Magnevist (brand of gadopentetate dimeglumine) Injection and Pharmacy Bulk Package  XXX 
Revlimid (lenalidomide) Capsules   XX  
Reyataz (atazanavir sulfate) Capsules  XX  
Treximet (sumatriptan and naproxen sodium) Tablets   X   
Votrient (pazopanib) Tablets  XXX 
Zometa (zoledronic acid) Injection  XXX 
Zmax (azithromycin extended release) for Oral Suspension  XX  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
AmBisome (amphotericin B) liposome for Injection   XX 
Amerge (naratriptan) Tablets    X  
Imitrex (sumatriptan) Nasal Spray and Tablets    X  
Mobic (meloxicam) Tablets and Oral Suspension    X PCI 
Prandin (repaglinide) Tablets   X  
PrandiMet (repaglinide/metformin HCl fixed-dose combination) Tablets     X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Ditropan (oxybutynin chloride) Tablets    X 
Ditropan XL (oxybutynin chloride) Extended Release Tablets    X 
Invanz (ertapenem) for Injection     
X
 
Ketalar (ketamine HCl) for Injection    X 
Lasix (furosemide) Tablets     X 
Lumigan (bimatoprost ophthalmic solution)    X 
Pristiq (desvenlafaxine) Extended-Release Tablets     
X
 

Razadyne (galantamine hydrobromide) Tablets, Oral Solution

Razadyne ER (galantamine HBr) Extended-Release Capsules 

    X 
Sandostatin (octreotide acetate) Injection    X 
Xalatan (latanoprost ophthalmic solution)    X 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Novantrone (mitoxantrone) Injection     MG
Ziagen (abacavir sulfate) Tablets and Oral Solution      MG