Safety Information > July 2012

Safety Information > July 2012

 

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 X X X X   MG Butrans (buprenorphine) Transdermal System * Extended-Release and Long-Acting Opioids REMS X X X X   MG Dantrium (dantrolene sodium) Oral Capsule X   X X X   Dolophine (methadone hydrochloride) Tablets * Extended-Release and Long-Acting Opioids REMS X X X X   MG Duragesic (Fentanyl Transdermal System) * Extended-Release and Long-Acting Opioids REMS X X X X   MG Embeda (morphine sulfate and naltrexone hydrochloride) Extended-Release Capsules  * Extended-Release and Long-Acting Opioids REMS X X X X   MG Exalgo (hydromorphone HCl) Extended-Release Tablets  * Extended-Release and Long-Acting Opioids REMS X X X X   MG Kadian (morphine sulfate) Extended-Release Capsules * Extended-Release and Long-Acting Opioids REMS X X X X   MG Methadone hydrochloride Oral Solution and Concentrate * Extended-Release and Long-Acting Opioids REMS X X X X   MG MS Contin (Morphine Sulfate Controlled-Release) Tablets * Extended-Release and Long-Acting Opioids REMS X X X X   MG Nucynta ER (tapentadol) Extended-Release Oral Tablets * Extended-Release and Long-Acting Opioids REMS X X X X   MG Opana ER (oxymorphone hydrochloride) Extended-Release Tablets * Extended-Release and Long-Acting Opioids REMS X X X X   MG Oxycontin (oxycodone hydrochloride controlled-release) Tablets * Extended-Release and Long-Acting Opioids REMS X X X X   MG Truvada (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) Tablets X X X X     (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)     X X X X   Diovan (valsartan) Tablets and Diovan HCT (valsartan/hydrochlorothiazide)   X X X X   (Click on drug name to go to detailed view) BW C W P AR PPI/MG Caduet (amlodipine/atorvastatin) Tablets     X X X   Eraxis (anidulafungin) Powder for Injection     X X     Mirapex (pramipexole dihydrochloride)     X X X   Natrecor (nesiritide) for Injection      X X  X   Prograf (tacrolimus) Capsules and Injection      X X  X   Sanctura (trospium chloride)     X X X   Strattera (atomoxetine hydrochloride) capsule     X X     Zinecard (dexrazoxane) for injection      X 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 X    Somavert (pegvisomant for injection)        X X    Sylatron (peginterferon alfa-2b)        X     Thyrogen (thyrotropin alfa for injection)       X X   Trental (pentoxifylline) Extended-Release Tablets        X 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