Drug Safety Labeling Changes - November 2010

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November 2010

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
Rifadin (rifampin capsules USP), and Rifadin (rifampin for injection USP) IV-Contraindications-PrecautionsAdverse Reactions---
Rifater (rifampin, isoniazid and pyrazinamide) Tablets-Contraindications-PrecautionsAdverse Reactions---
Feraheme (ferumoxytol) Injection--WarningsPrecautions----
Rapamune (sirolimus) Oral Solution and Tablets--WarningsPrecautionsAdverse Reactions---
Revatio (sildenafil) Tablets and Injection--WarningsPrecautionsAdverse Reactions---
Zemuron (rocuronium bromide) Injection--WarningsPrecautions----
Adderall XR (dextroamphetamine mixed salts of a single-entity amphetamine product) Capsules---Precautions----
Cardizem CD (diltiazem hydrochloride) Capsules and Tablets Cardizem LA (diltiazem hydrochloride) Extended-Release Tablets---PrecautionsAdverse Reactions---
Metopirone (metyrapone USP) 250 mg, Capsules---PrecautionsAdverse Reactions---
Rozerem (ramelteon) Tablets---Precautions----
Drug Name BW C W P AR PPI MG PCI
Tiazac (diltiazem hydrochloride) Extended Release Capsules---PrecautionsAdverse Reactions---
Trandate (labetalol hydrochloride) Tablets and Injection---Precautions----
Vfend (voriconazole) Tablets, Injection, and Oral Suspension---Precautions----
Eraxis (anidulafungin) for Injection----Adverse Reactions---
Nucynta (tapentadol) Immediate-release Oral Tablets----Adverse Reactions---
Olux-E (clobetasol propionate) Foam, 0.05 %----Adverse Reactions---
Paraplatin (carboplatin) for Injection----Adverse Reactions---
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