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U.S. Department of Health and Human Services

Safety

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February 2014

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
Promacta (eltrombopag) Tablets 
X
 XXXMG
Nizoral (ketoconazole) Tablet 
X
  X X MG 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Bravelle (urofollitropin for injection, purified) XXX  
Juvisync (sitagliptin and simvastatin) Tablets XXX MG
Menopur (menotropins for injection) XXX  
Mevacor (lovastatin) XXX  
Samsca (tolvaptan) Tablets  X  XMG
Vytorin (ezetimibe/simvastatin) Tablets XXX MG
Zocor (simvastatin) Tablets XXX MG
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Afinitor (everolimus) Tablets for Oral Administration
Afinitor Disperz (everolimus tablets for oral suspension)
 
  XX  
Agrylin (anagrelide hydrochloride) Capsules   XX  
Aloxi (palonosetron hydrochloride) Injection   XX  
Astagraf XL (tacrolimus extended-release capsules)   XXX 
Imuran (azathioprine) Tablets and Imuran (azathioprine) Injection   X   
Lodosyn (carbidopa)  XXX 
Simponi Aria (golimumab) Injection For Intravenous Use  XX  
Victrelis (boceprevir) 200 mg capsules  XXXPCI/MG
Zelboraf (vemurafenib) Tablets  XXX 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Biltricide (praziquantel) Tablets   XX 
Juxtapid (lomitapide) Capsules    X PCI, MG 
Nexium (esomeprazole magnesium) Delayed-Release Oral Suspension   X  
Nexium I.V. (esomeprazole sodium) for Intravenous Injection   X  
Prilosec (omeprazole) Delayed-Release Capsules   X  
Prilosec (omeprazole magnesium) Delayed-Release Oral Suspension   X  
Vimovo (naproxen/esomeprazole magnesium) Delayed-Release Tablets   X  
Xarelto (rivaroxaban) Tablets    X  
Zegerid (omeprazole/sodium bicarbonate) Powder for Oral Suspension   X  
Zegerid (omeprazole/sodium bicarbonate) Capsules   X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Brovana (arformoterol tartrate) Inhalation Solution     
X
 
Lunesta (eszopiclone) Film Coated Oral Tablets     
X
 
Ozurdex (dexamethasone intravitreal implant)     
X
 
Pepcid (famotidine) Tablet    X 
Strattera (atomoxetine hydrochloride) Capsules    X 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Janumet XR (sitagliptin and metformin HCl Extended-Release) Tablets      PCI/MG
Soriatane (acitretin) Capsules      MG