Drug Safety Labeling Changes - March 2012

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March 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
Atacand HCT (candesartan cilextetil/hydrochlorothiazide) TabletsBoxed Warning-WarningsPrecautions----
Sporanox (itraconazole) Oral SolutionBoxed WarningContraindicationsWarningsPrecautionsAdverse Reactions---
Enablex (darifenacin) Extended-Release Tablets--WarningsPrecautions----
Janumet (sitagliptin and metformin fixed-dose combination) Tablets--WarningsPrecautions----
Januvia (sitagliptin) Tablets--WarningsPrecautions----
Kombiglyze XR (saxagliptin/metformin hydrochloride extended-release) Tablets--WarningsPrecautions----
Lidocaine in 5% Dextrose Injection, USP--Warnings-Adverse Reactions---
Magnevist (brand of gadopentetate dimeglumine) Injection and Pharmacy Bulk Package--WarningsPrecautionsAdverse Reactions---
Treximet (sumatriptan and naproxen sodium) Tablets--Warnings-----
Zometa (zoledronic acid) Injection--WarningsPrecautionsAdverse Reactions---
Drug Name BW C W P AR PPI MG PCI
AmBisome (amphotericin B) liposome for Injection---PrecautionsAdverse Reactions---
Amerge (naratriptan) Tablets---Precautions----
Imitrex (sumatriptan) Nasal Spray and Tablets---Precautions----
Mobic (meloxicam) Tablets and Oral Suspension---Precautions----
Prandin (repaglinide) Tablets---Precautions----
PrandiMet (repaglinide/metformin HCl fixed-dose combination) Tablets---Precautions----
Ditropan (oxybutynin chloride) Tablets----Adverse Reactions---
Invanz (ertapenem) for Injection----Adverse Reactions---
Ketalar (ketamine HCl) for Injection----Adverse Reactions---
Lasix (furosemide) Tablets----Adverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Lumigan (bimatoprost ophthalmic solution)----Adverse Reactions---
Razadyne (galantamine hydrobromide) Tablets, Oral Solution----Adverse Reactions---
Razadyne ER (galantamine HBr) Extended-Release Capsules ----Adverse Reactions---
Sandostatin (octreotide acetate) Injection----Adverse Reactions---
Xalatan (latanoprost ophthalmic solution)----Adverse Reactions---
Novantrone (mitoxantrone) Injection--------
Ziagen (abacavir sulfate) Tablets and Oral Solution--------
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