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Drug Safety Labeling Changes - July 2016

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July 2016

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
Avelox (moxifloxacin hydrochloride)Boxed Warning-WarningsPrecautionsAdverse Reactions---
Cipro (ciprofloxacin hydrochloride) Tablets, Solution, Oral SuspensionCipro XR (ciprofloxacin extended release) TabletsBoxed Warning-WarningsPrecautionsAdverse Reactions---
Factive (gemifloxacin mesylate)Boxed Warning-WarningsPrecautionsAdverse Reactions---
Levaquin (levofloxacin)Boxed Warning-WarningsPrecautionsAdverse Reactions---
Moxifloxacin InjectionBoxed Warning-WarningsPrecautionsAdverse Reactions---
Noroxin (norfloxacin)Boxed Warning-WarningsPrecautionsAdverse Reactions---
Synjardy (empagliflozin and metformin hydrochloride)Boxed WarningContraindicationsWarningsPrecautions----
Evotaz (atazanavir/cobicistat)-ContraindicationsWarningsPrecautions----
Hicon (for the preparation of sodium iodide I 131 solution or sodium iodide I 131 capsules)-ContraindicationsWarningsPrecautionsAdverse Reactions---
Isoniazid Tablets-Contraindications--Adverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Lamprene (clofazimine)-ContraindicationsWarningsPrecautionsAdverse Reactions---
Mirvaso (brimonidine)-ContraindicationsWarningsPrecautionsAdverse Reactions---
Prismasol and Phoxillum Renal Replacement Solution-ContraindicationsWarningsPrecautionsAdverse Reactions---
Acetadote (acetylcysteine) Injection--WarningsPrecautionsAdverse Reactions---
Aromasin (exemestane)--WarningsPrecautions----
Caprelsa (vandetanib)--WarningsPrecautions----
Eliquis (apixaban)--WarningsPrecautions----
Epivir (lamivudine) Tablets and Oral Solution--WarningsPrecautions----
Faslodex (fulvestrant)--WarningsPrecautionsAdverse Reactions---
Glyxambi (empagliflozin and linagliptin) --WarningsPrecautionsAdverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Humulin R U-500 (insulin human injection)--WarningsPrecautions----
Ilaris (canakinumab)--WarningsPrecautions----
Jardiance (empagliflozin)--WarningsPrecautions----
Kepivance (palifermin) Injection--WarningsPrecautionsAdverse Reactions---
Namzaric (memantine and donepezil hydrochlorides) Extended-release--WarningsPrecautions----
Thallous Chloride T1201 Injection--WarningsPrecautionsAdverse Reactions---
Yondelis (trabectedin)--WarningsPrecautionsAdverse Reactions---
Alinia (nitazoxanide)---PrecautionsAdverse Reactions---
Asmanex HFA (mometasone furoate)---Precautions----
Clinolipid (lipid injectable emulsion)---PrecautionsAdverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Dexilant (dexlansoprazole delayed-release capsules)---PrecautionsAdverse Reactions---
Dulera (formoterol fumarate, mometasone furoate)---Precautions----
Dysport (abobotulinumtoxinA)---PrecautionsAdverse Reactions---
Effient (prasugrel)---PrecautionsAdverse Reactions---
Flovent Diskus (fluticasone propionate inhalation powder)---PrecautionsAdverse Reactions---
Flovent HFA (fluticasone propionate)---Precautions----
Kadcyla (ado-trastuzumab emtansine)---Precautions----
Mirapex (pramipexole)---Precautions----
Mirapex ER (pramipexole) extended-release---PrecautionsAdverse Reactions---
Plegridy (peginterferon beta-1a)---Precautions----
Drug Name BW C W P AR PPI MG PCI
Pravachol (pravastatin sodium)---PrecautionsAdverse Reactions---
Tarka (trandolapril/verapamil hydrochloride ER tablets)---Precautions----
Xolair (omalizumab) Lyophilized Powder---PrecautionsAdverse Reactions---
Brilinta (ticagrelor)----Adverse Reactions---
Cubicin (daptomycin for injection)----Adverse Reactions---
Decadron (dexamethasone)----Adverse Reactions---
Docetaxel Injection----Adverse Reactions---
Durezol (difluprednate) ----Adverse Reactions---
Merrem I.V. (meropenem for injection)----Adverse Reactions---
Fluoroplex (fluorouracil)--------
Drug Name BW C W P AR PPI MG PCI
Habitrol Patch (nicotine transdermal system)--------
Repatha (evolocumab)--------
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