Drug Safety Labeling Changes - January 2010

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January 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
Exjade (deferasirox) tablets for oral suspensionBoxed WarningContraindicationsWarningsPrecautions----
Aristocort Forte (triamcinolone diacetate) injectable suspension-ContraindicationsWarningsPrecautionsAdverse Reactions---
Effexor (venlafaxine HCl) tablets and Effexor XR (venlafaxine HCl) extended-release capsule-Contraindications--Adverse Reactions---
Kaletra (lopinavir/ritonavir) oral solution and tablets-Contraindications-Precautions----
RotaTeq (rotavirus vaccine, live, pentavalent) oral solution-Contraindications--Adverse ReactionsPatient Package Insert--
Cardene (nicardipine hydrochloride) premixed injection--WarningsPrecautionsAdverse Reactions---
Coumadin (warfarin sodium) tablet and injection--Warnings-----
Kenalog (triamcinolone acetonide) injectable suspension--Warnings-----
R-Gene 10 (arginine hydrochloride) injection--Warnings-Adverse Reactions---
Remodulin (treprostinil) injection--WarningsPrecautionsAdverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Toprol-XL (metoprolol succinate) extended release tablets--WarningsPrecautionsAdverse Reactions---
Videx EC (didanosine) delayed release capsules and Videx(didanosine) pediatric powder for oral solution--WarningsPrecautions----
Viramune (nevirapine) oral suspension and tablets--WarningsPrecautions----
Zyprexa (olanzapine) tablets, orally disintegrating tablets and IM injection--Warnings-----
Clozaril (clozapine HCl) tablets---PrecautionsAdverse Reactions---
Sandostatin (octreotide acetate) injection and Sandostatin LAR Depot Injection---Precautions----
Uniretic (moexipril hydrochloride and hydrochlorothiazide) tablets---Precautions----
Zostavax (zoster vaccine live) suspension for subcutaneous injection---Precautions-Patient Package Insert--
Bumex (bumetanide) tablets----Adverse Reactions---
Ethrane (enflurane) liquid for inhalation----Adverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Indocin I.V. (indomethacin) injection----Adverse Reactions---
Rapamune (sirolimus) tablets and oral solution----Adverse Reactions---
Ultane (sevoflurane) liquid for inhalation----Adverse Reactions---
Cardura (doxazosin mesylate) tablets-----Patient Package Insert--
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