Drug Safety Labeling Changes - July 2012

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July 2012

This monthly summary of drug label changes provides a quick view of the sections that have changed. Click on a drug name to view the changes in more detail.

Key to Label Sections
BW - Boxed Warning C - Contraindications W - Warnings P - Precautions
AR - Adverse Reactions PPI - Patient Package Insert MG - Medication Guide PCI - Patient Counseling Information

Sections Modified
Drug Name BW C W P AR PPI MG PCI
Avinza (morphine sulfate) Extended-Release Capsules Boxed WarningContraindicationsWarningsPrecautions----
Butrans (buprenorphine) Transdermal SystemBoxed WarningContraindicationsWarningsPrecautions----
Dantrium (dantrolene sodium) Oral CapsuleBoxed Warning-WarningsPrecautionsAdverse Reactions---
Dolophine (methadone hydrochloride) TabletsBoxed WarningContraindicationsWarningsPrecautions----
Duragesic (Fentanyl Transdermal System)Boxed WarningContraindicationsWarningsPrecautions----
Embeda (morphine sulfate and naltrexone hydrochloride) Extended-Release Capsules Boxed WarningContraindicationsWarningsPrecautions----
Exalgo (hydromorphone HCl) Extended-Release Tablets Boxed WarningContraindicationsWarningsPrecautions----
Kadian (morphine sulfate) Extended-Release CapsulesBoxed WarningContraindicationsWarningsPrecautions----
Methadone hydrochloride Oral Solution and ConcentrateBoxed WarningContraindicationsWarningsPrecautions----
MS Contin (Morphine Sulfate Controlled-Release) TabletsBoxed WarningContraindicationsWarningsPrecautions----
Drug Name BW C W P AR PPI MG PCI
Nucynta ER (tapentadol) Extended-Release Oral TabletsBoxed WarningContraindicationsWarningsPrecautions----
Opana ER (oxymorphone hydrochloride) Extended-Release TabletsBoxed WarningContraindicationsWarningsPrecautions----
Oxycontin (oxycodone hydrochloride controlled-release) TabletsBoxed WarningContraindicationsWarningsPrecautions----
Truvada (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) TabletsBoxed WarningContraindicationsWarningsPrecautions----
AzaSite (azithromycin ophthalmic solution)-Contraindications------
Biaxin Filmtabs (clarithromycin tablets) Biaxin Granules (clarithromycin for oral suspension, USP)Biaxin XL Filmtabs (clarithromycin extended release tablets)-ContraindicationsWarningsPrecautionsAdverse Reactions---
Diovan (valsartan) Tablets and Diovan HCT (valsartan/hydrochlorothiazide)-ContraindicationsWarningsPrecautionsAdverse Reactions---
Caduet (amlodipine/atorvastatin) Tablets--WarningsPrecautionsAdverse Reactions---
Eraxis (anidulafungin) Powder for Injection--WarningsPrecautions----
Mirapex (pramipexole dihydrochloride)--WarningsPrecautionsAdverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Natrecor (nesiritide) for Injection --WarningsPrecautionsAdverse Reactions---
Prograf (tacrolimus) Capsules and Injection--WarningsPrecautionsAdverse Reactions---
Sanctura (trospium chloride)--WarningsPrecautionsAdverse Reactions---
Strattera (atomoxetine hydrochloride) capsule--WarningsPrecautions----
Zinecard (dexrazoxane) for injection--WarningsPrecautions----
Mircette (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets---Precautions----
Qvar (beclomethasone dipropionate HFA) Inhalation---PrecautionsAdverse Reactions---
Somavert (pegvisomant for injection)---PrecautionsAdverse Reactions---
Thyrogen (thyrotropin alfa for injection)---PrecautionsAdverse Reactions---
Trental (pentoxifylline) Extended-Release Tablets---PrecautionsAdverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Faslodex (fulvestrant) Injection----Adverse Reactions---
Lumizyme (alglucosidase alfa)----Adverse Reactions---
Myozyme (alglucosidase alfa)----Adverse Reactions---
Ocufen (flurbiprofen sodium ophthalmic solution, USP)----Adverse Reactions---
Proleukin (aldesleukin)----Adverse Reactions---
Welchol (colesevelam HCl) Tablets and Oral Suspension----Adverse Reactions---
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