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U.S. Department of Health and Human Services

Safety

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July 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

Avinza (morphine sulfate) Extended-Release Capsules 

* Extended-Release and Long-Acting Opioids REMS

XXXX MG

Butrans (buprenorphine) Transdermal System

* Extended-Release and Long-Acting Opioids REMS

XXXX MG
Dantrium (dantrolene sodium) Oral CapsuleX XXX 

Dolophine (methadone hydrochloride) Tablets

* Extended-Release and Long-Acting Opioids REMS

XXXX MG

Duragesic (Fentanyl Transdermal System)

* Extended-Release and Long-Acting Opioids REMS

XXXX MG

Embeda (morphine sulfate and naltrexone hydrochloride) Extended-Release Capsules 

* Extended-Release and Long-Acting Opioids REMS

XXXX MG

Exalgo (hydromorphone HCl) Extended-Release Tablets 

* Extended-Release and Long-Acting Opioids REMS

X
XXX MG

Kadian (morphine sulfate) Extended-Release Capsules

* Extended-Release and Long-Acting Opioids REMS

XXXX MG

Methadone hydrochloride Oral Solution and Concentrate

* Extended-Release and Long-Acting Opioids REMS

XXXX MG

MS Contin (Morphine Sulfate Controlled-Release) Tablets

* Extended-Release and Long-Acting Opioids REMS

XXXX MG

Nucynta ER (tapentadol) Extended-Release Oral Tablets

* Extended-Release and Long-Acting Opioids REMS

XXXX MG

Opana ER (oxymorphone hydrochloride) Extended-Release Tablets

* Extended-Release and Long-Acting Opioids REMS

XXXX MG

Oxycontin (oxycodone hydrochloride controlled-release) Tablets

* Extended-Release and Long-Acting Opioids REMS

XXXX MG
Truvada (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) TabletsXXXX  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
AzaSite (azithromycin ophthalmic solution)   X    
Biaxin Filmtabs (clarithromycin tablets)
Biaxin Granules (clarithromycin for oral suspension, USP)
Biaxin XL Filmtabs (clarithromycin extended release tablets)

 
 XXXX 
Diovan (valsartan) Tablets and Diovan HCT (valsartan/hydrochlorothiazide) XXXX 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Caduet (amlodipine/atorvastatin) Tablets  XXX 
Eraxis (anidulafungin) Powder for Injection  XX  
Mirapex (pramipexole dihydrochloride)  XXX 
Natrecor (nesiritide) for Injection   XX 
Prograf (tacrolimus) Capsules and Injection   XX 
Sanctura (trospium chloride)  XXX 
Strattera (atomoxetine hydrochloride) capsule  XX  
Zinecard (dexrazoxane) for injection   X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Mircette (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets    X  
Qvar (beclomethasone dipropionate HFA) Inhalation    X 
Somavert (pegvisomant for injection)    X 
Sylatron (peginterferon alfa-2b)    X  
Thyrogen (thyrotropin alfa for injection)   XX 
Trental (pentoxifylline) Extended-Release Tablets    X 
Victrelis (boceprevir) Capsules   X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Faslodex (fulvestrant) Injection    X 
Lumizyme (alglucosidase alfa)     
X
 
Lupron Depot (leuprolide acetate for depot suspension)    X 
Myozyme (alglucosidase alfa)    X 
Ocufen (flurbiprofen sodium ophthalmic solution, USP)    X 
Proleukin (aldesleukin)    X 
VESIcare (solifenacin succinate) Tablets    X 
Welchol (colesevelam HCl) Tablets and Oral Suspension    X 
Zytiga (abiraterone acetate) Tablets     
X