Drug Safety Labeling Changes - December 2010

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December 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
Magnevist (gadopentetate dimeglumine) injection and pharmacy bulk package injectionBoxed WarningContraindicationsWarningsPrecautions----
Omniscan (gadodiamide) injection and pharmacy bulk package injectionBoxed WarningContraindicationsWarningsPrecautions----
Optimark (gadoversetamide) injection and pharmacy bulk package injectionBoxed WarningContraindicationsWarnings-----
Prohance (gadoteridol) injection and multipack injectionBoxed Warning-WarningsPrecautions----
Copegus (ribavirin) tablets-ContraindicationsWarningsPrecautions----
Terconazole Vaginal Cream-Contraindications--Adverse Reactions---
Innopran XL (propranolol hydrochloride) capsules--WarningsPrecautionsAdverse Reactions---
Remicade (inflximab ) for Intravenous (IV) injection--Warnings-Adverse Reactions---
Zegerid OTC capsules--Warnings-----
Campral (acamprosate calcium) delayed-release tablets---Precautions----
Drug Name BW C W P AR PPI MG PCI
Dermatop (prednicarbate cream) Cream and Dermatop (prednicarbate ointment) ointment---Precautions----
Inomax (nitric oxide) inhalation---Precautions----
Ketek (telithromycin) tablets---Precautions----
Riomet (metformin HCl) oral solution---Precautions----
Uroxatral (alfuzosin HCL) extended-release tablets---Precautions----
Zyprexa Relprevv (olanzapine) for extended release injectable suspension---Precautions----
Chantix (varenicline) tablets----Adverse Reactions---
Intelence (etravirine) tablet----Adverse Reactions---
Timentin (sterile ticarcillin disodium and clavulanate potassium) for intravenous administration----Adverse Reactions---
Treanda (bendamustine hydrochloride) lyophilized solid for injection----Adverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Xolegel (ketoconazole) topical gel----Adverse Reactions---
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