Drug Safety Labeling Changes - January 2015

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January 2015

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
Fragmin (dalteparin) InjectionBoxed Warning-WarningsPrecautions----
Remicade (infliximab)Boxed Warning-Warnings-----
Atripla Tablets (efavirenz/emtricitabine/tenofovir disoproxil fumarate)-ContraindicationsWarningsPrecautions----
Isordil Titradose (isosorbide dinitrate) Tablets-Contraindications-Precautions----
Lotensin (benazepril hydrochloride) Tablets-Contraindications------
Nitrolingual Pumpspray (nitroglycerin) Spray-ContraindicationsWarningsPrecautionsAdverse Reactions---
Afinitor (everolimus) Tablets and Afinitor Disperz Tablets--WarningsPrecautions----
Biaxin (clarithromycin) tabs, granules, XL Filmtabs--Warnings-----
Depakene (valproic acid) Capsules and Oral SolutionDepakote (divalproex sodium) Delayed ReleaseDepakote ER (Extended Release) TabletsDepakote Sprinkle Capsules (divalproex sodium coated particles in capsules)Depacon (valproate sodium) Injection--WarningsPrecautions----
Depo Provera and Depo sub-Q Provera (medroxyprogesterone acetate) Injection--WarningsPrecautionsAdverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Gleevec (imatinib) Tablets--WarningsPrecautions----
Imbruvica (ibrutinib) Capsules--WarningsPrecautions----
Reclast (zoledronic acid) Injection--WarningsPrecautions----
Savella (milnacipran) Tablets--WarningsPrecautions----
Tasigna (nilotinib) Capsules--WarningsPrecautions----
Zemuron (rocuronium bromide) Injection--WarningsPrecautions----
Zometa (zoledronic acid) Injection--WarningsPrecautions----
Zortress (everolimus) Tablets--WarningsPrecautions----
Loniten (minoxidil) Tablets---PrecautionsAdverse Reactions---
Pletal (cilostazol) Tablets---Precautions----
Drug Name BW C W P AR PPI MG PCI
Procardia Capsules and Procardia XL (nifedipine) Tablets---Precautions----
Zytiga (Abiraterone) Tablets---Precautions----
Provigil (modafinil) Tablets----Adverse Reactions---
Vyvanse (lisdexamfetamine dimesylate) Tablets----Adverse Reactions---
Busulfex (busulfan) Injection--------
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