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U.S. Department of Health and Human Services

Safety

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January 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

Accupril (quinapril hydrochloride) 5 mg, 10 mg 20 mg, 40 mg Tablets 

 

* Anti-Hypertensive Drugs

X
  

Accuretic (quinapril HCl/ hydrochlorothiazide) 10/12.5 mg, 20/12.5 mg, 20/25 mg Tablets

 

* Anti-Hypertensive Drugs

 X   X

Altace (ramipril) 1.25, 2.5, 5, and 10 mg Tablets

 

* Anti-Hypertensive Drugs

X XX X

Avalide (irbesartan/hydrochlorothiazide) Tablets, 150/12.5 mg and 300/12.5 mg

 

* Anti-Hypertensive Drugs

X XX X

Avapro (irbesartan) 75 mg, 150 mg, and 300 mg Tablets

 

* Anti-Hypertensive Drugs

X XX X

Azor (amlodipine/olmesartan) 5/20 mg, 10/20 mg, 5/40 mg, and 10/40 mg Tablets

 

* Anti-Hypertensive Drugs

X XX X

Benicar HCT (olmesartan medoxomil/hydrochlorothiazide) 20/12.5 mg, 40/12.5 mg, and 40/25 mg Tablets

 

* Anti-Hypertensive Drugs

X XX X

Diovan (valsartan) 40 mg, 80 mg, 160 mg, and 320 mg Tablets

 

* Anti-Hypertensive Drugs

X XX X

Diovan HCT (valsartan/hydrochlorothiazide) 80/12.5 mg, 160/12.5 mg,160/25 mg, 320/12.5 mg, and 320/25 mg Tablets

 

* Anti-Hypertensive Drugs

X XX X

Exforge (amlodipine/valsartan) 5/160 mg, 10/160 mg, 5/320 mg, and 10/320 mg Tablets

 

* Anti-Hypertensive Drugs

X XX X

Exforge HCT (amlodipine/valsartan/hydrochlorothiazide) 5/160/12.5 mg, 10/160/12.5 mg, 5/160/25 mg, 10/160/25 mg, and 10/320/25 mg Tablets

 

* Anti-Hypertensive Drugs

X XX X

Lotensin (benazepril) 5 mg, 10 mg, 20 mg, and 40 mg Tablets

 

* Anti-Hypertensive Drugs

X XX X

Lotensin HCT (benazepril/hydrochlorothiazide) 5/6.25 mg, 10/12.5 mg, 20/12.5 mg, and 25/25/mg Tablets

 

* Anti-Hypertensive Drugs

X XX X

Lotrel (amlodipine besylate and benazepril hydrochloride) 2.5/10 mg, 5/10 mg, 5/20 mg, 10/20 mg, 5/40 mg, and 10/40 mg Tablets

 

* Anti-Hypertensive Drugs

X XX X

Mavik (trandolapril) 1 mg, 2 mg and 4 mg Tablets

 

* Anti-Hypertensive Drugs

X XX X

Micardis (telmisartan) 20 mg, 40 mg, and 80 mg Tablets

 

* Anti-Hypertensive Drugs

X XX X

Micardis HCT (telmisartan/hydrochlorothiazide) 40/12.5 mg, 80/12.5 mg, and 80/25 mg Tablets

 

* Anti-Hypertensive Drugs

X XX X

Tarka (trandolapril/verapamil hydrochloride) 2/180 mg, 1/240 mg 2/240 mg and 4/240 mg Tablets

 

* Anti-Hypertensive Drugs

X XX X

Teveten (eprosartan mesylate) 400 mg and 600 mg Tablets

 

* Anti-Hypertensive Drugs

X XX X

Teveten HCT (eprosartan mesylate/hydrochlorothiazide) 600/12.5 mg and 600/25 mg Tablets

 

* Anti-Hypertensive Drugs

X XX X

Tribenzor (olmesartan medoxomil/amlodipine/hydrochlorothiazide) 20/5/12.5 mg, 40/5/12.5 mg, 40/5/25 mg, 40/10/12.5 and 40/10/25 mg Tablets 
 

 

* Anti-Hypertensive Drugs

X XX X

Univasc (moexipril hydrochloride) 7.5 mg and 15 mg Tablets

Uniretic (moexipril hydrochloride/hydrochlorothiazide) 7.5/12.5 mg, 15/12.5 mg and 15/25 mg Tablets 

 

* Anti-Hypertensive Drugs

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

BW

C

W

P

AR

PPI/MG
Ceftriaxone for Injection and Dextrose Injection in Duplex Container XX X 
Evoclin (clindamycin phosphate) Foam  PPI 
Mavik (trandolapril) 1 mg, 2 mg, and 4 mg Tablets  XX 
Micardis (telmisartan) 20 mg, 40 mg, and 80 mg Tablets X  X 
Micardis HCT (telmisartan/hydrochlorothiazide) 40/12.5 mg, and 80/12.5 mg, and 80/25 mg Tablets XX X 
Micardis HCT (telmisartan/hydrochlorothiazide) Tablets XX X 
Twynsta (telmisartan/amlodipine) Tablets X  XPPI
Xenical (orlistat) Capsules XX  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Chantix (varenicline) Tablets 0.5 mg and 1 mg  XXX 
Erbitux (cetuximab)  XX  
Fanapt (iloperidone) Tablets   XX  
Fazaclo (clozapine) Orally Disintegrating Tablets  XXX 
Gralise (gabapentin) Tablets, 300 mg and 600 mg  XX  
Morphine Sulfate Oral Solution, 10 mg/5 mL, 20 mg/5 mL, and 100 mg/5 mL  XXXMG
Morphine Sulfate Tablets, 15 mg and 30 mg  XXXPCI
Nexium (esomeprazole sodium) For Injection  XXX 
Nexium (esomeprazole magnesium) Delayed-Release Capsules, 20 mg and 40 mg;
Delayed-Release Oral Suspension, 10 mg, 20 mg, and 40 mg
  XXXMG
Perforomist (formoterol fumarate) Inhalation Solution  XXX 
Pradaxa (dabigatran etexilate mesylate) Capsules   XX MG 
Vimovo (naproxen/esomeprazole magnesium) Delayed-Release Tablets  XXXMG
Vytorin (ezetimibe/simvastatin) Tablets  XXX 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG

Amturnide (amlodipine/aliskiren/hydrochlorothiazide) 150/5/12.5 mg, 300/5/12.5 mg, 300/5/25 mg, 300/10/12.5 mg and 300/10/25 mg Tablets 

 

*Renin Inhibitors

   X 
Droxia (hydroxyurea capsules, USP) 200 mg, 300 mg, 400 mg and Hydrea (hydroxyurea capsules, USP) 500 mg    X  
Marcaine and Marcaine with Epinephrine Injection
Marcaine Spinal Injection
Bupivacaine hydrochloride and epinephrine bitartrate injection
 
   X  
Multaq (dronedarone hydrochloride) 400 mg Tablets    X  
Parlodel SnapTabs (bromocriptine mesylate) Tablets and Capsules    X  

Tekamlo (aliskiren/amlodipine) 150 mg/5 mg, 150 mg/10 mg, 300 mg/5 mg and 300 mg/10 mg Tablets 

 

*Renin Inhibitors

   X 

Tekturna (aliskiren) 150 mg, 300 mg Tablets

 

*Renin Inhibitors

      

Tekturna HCT (aliskiren/hydrochlorothiazide) 150/12.5 mg, 150/25 mg, 300/12.5 mg, and 300/25 mg Tablets

 

*Renin Inhibitors

   XX 

Valturna (aliskiren and valsartan) 150/160 mg and 300/320 mg Tablets 

 

*Renin Inhibitors

   X 
Zetia (ezetimibe) Tablets    X  
Zyban (bupropion hydrochloride) Sustained-Release Tablets   X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Astelin (azelastine) Nasal Spray     
X
 
Enablex (darifenacin) extended-release tablets    X 
Fibricor (fenofibric acid) Tablets    X 

Lupron Depot (leuprolide acetate for depot suspension), 11.25 mg

Lupron Depot (leuprolide acetate for depot suspension), 3.75 mg

    X 
Synarel (nafarelin acetate) nasal solution, 2 mg/mL     X 
VESIcare (solifenacin succinate) Tablets    X 
Vidaza (azacitidine) for Injection    X 
Welchol (colesevelam HCL) Tablets and Welchol (colesevelam HCl) for Oral Suspension    X 
Zonegran (zonisamide) Capsules     
X