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U.S. Department of Health and Human Services

Safety

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April 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

Avinza (morphine sulfate) Extended-Release Capsules 

*ER/LA opioid analgesics

X XX MG

Butrans (buprenorphine) Transdermal System 

*ER/LA opioid analgesics

X
 XX MG

Dolophine (methadone hydrochloride) Tablets

*ER/LA opioid analgesics

X XX MG

Duragesic (fentanyl transdermal system)

*ER/LA opioid analgesics

X XX MG

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

*ER/LA opioid analgesics

X XX MG

Exalgo (hydromorphone HCl) Extended-Release Tablets

*ER/LA opioid analgesics

X XX MG

Kadian (morphine sulfate) Extended-Release Capsules

*ER/LA opioid analgesics

X XX MG

MS Contin (morphine sulfate) Extended-Release Tablets

*ER/LA opioid analgesics

X XX MG

Nucynta ER (tapentadol) extended-release tablets

*ER/LA opioid analgesics

X XX MG

Opana ER (oxymorphone hydrochloride) Extended-Release Tablets

*ER/LA opioid analgesics

X XX MG

Oxycontin (oxycodone hydrochloride) Extended-Release Tablets

*ER/LA opioid analgesics

X XX MG

Palladone (hydromorphone hydrochloride) Extended-Release Capsules

*ER/LA opioid analgesics

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

BW

C

W

P

AR

PPI/MG
Aptivus (tipranavir) capsules, 250 mg, and Aptivus (tipranavir) oral solution, 100 mg/mL  X X  
VFEND (voriconazole) Tablets
VFEND I.V. (voriconazole) for Injection
VFEND (voriconazole) for Oral Suspension
 
 X X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Adcirca (tadalafil) 20 mg Tablets   XXX 
Benlysta (belimumab)   XX MG
Cialis (tadalafil) tablets 5 mg   XX  
Delflex Peritoneal Dialysis (PD) Solutions (1.5%, 2.5% and 4.25% Dextrose with Standard Calcium/Standard Magnesium and with Standard Calcium/Low Magnesium)
Delflex PD Solutions (1.5%, 2.5% and 4.25% Dextrose with Low Calcium/Low Magnesium)
  XX  
Excedrin Migraine (acetaminophen 250 mg, aspirin 250 mg, caffeine 65 mg) Tablets, Caplets, and Geltabs   X   
Gilenya (fingolimod)   XX  
Kuvan (sapropterin dihydrochloride)   XX PI
Levitra (vardenafil hydrochloride) tablets   XX  
Oncaspar (pegaspargase)  XXX 

Prezista (darunavir) tablets, 75 mg, 150 mg, 600 mg, and 800 mg
Prezista (darunavir) oral suspension, 100 mg/mL

  XX  
Sprycel (dasatinib) 20, 50, 70, 80, 100 and 140 mg tablets   XX  
Staxyn (vardenafil hydrochloride) orally disintegrating tablets   XX  
Stendra (avanafil)   XX  
Suboxone (buprenorphine and naloxone) sublingual film   XX  
Tarceva (erlotinib) tablets, 25mg, 100mg and 150mg   XXX 
Torisel Kit (temsirolimus) Injection, 25 mg/mL   XXX 
Viibryd (vilazodone hydrochloride) 10 mg, 20 mg, and 40 mg tablets   XXX 
Zometa (zoledronic acid) Injection, 4 mg/100 mL single-use,
ready-to-use bottle and 4 mg/5 mL single-use vial of concentrate
 
  XXX 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Cleocin T (clindamycin phosphate) lotion, solution, and gel, 1 Percent    X  
Dilantin - 125 (phenytoin) Oral Suspension and Dilantin (phenytoin) Injection    X  
Dulera (mometasone furoate/formoterol fumarate) Inhalation Aerosol    X MG
Fanapt (iloperidone) 1, 2, 4, 6, 8, 10, and 12 mg tablets    X  
Invega (paliperidone) tablets, and Invega Sustenna (paliperidone) extended-release suspension for intramuscular injection    XX 
Isentress (raltegravir) film-coated tablets, 400 mg,
Isentress (raltegravir) chewable tablets, 25 mg, 100 mg
Isentress (raltegravir) for oral suspension, 100 mg
 
   X  
Nitrostat (nitroglycerin USP) 0.3, 0.4, 0.6 mg Sublingual Tablets    X  
Sprix (ketorolac tromethamine) Nasal Spray     X  
TOBI Podhaler (tobramycin inhalation powder) for oral inhalation, 28 mg    XX 
TOBI (tobramycin inhalation solution, USP) 300 mg/5mL    X  
Trental (pentoxifylline) extended-release tablets, 400 mg    X  
Xyrem (sodium oxybate) oral solution    X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Altoprev (lovastatin) extended-release tablets; 20, 40, and 60 mg     
X
 
Clarinex (desloratadine) Tablets, Clarinex (desloratadine) Oral Solution, and Clarinex (desloratadine) Reditabs     
X
 
Docetaxel Injection Solution for Intravenous Infusion, 10 mg/mL, 20 mg/12mL, 80 mg/8mL, and 160 mg/16mL     
X
 
Edarbi (azilsartan medoxomil) 40 mg and 80 mg Tablets     
X
 
Edaryclor (azilsartan medoxomil and chlorthalidone) 40 mg/12.5 mg and 40/25 mg Tablets     
X
 
Rebif (interferon beta-1a) injection     XMG
Risperdal (risperidone) tablets
Risperdal (risperidone) oral solution
Risperdal M-TAB (risperidone) orally disintegrating tablets Risperdal Consta (risperidone) long acting injection
    X 
Uroxatral (alfuzosin hydrochloride) extended release tablets    X 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Zovirax (acyclovir) 5 Percent Cream      PI