Drug Safety Labeling Changes - August 2013

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August 2013

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
Letairis (Ambrisentan) Tablets-ContraindicationsWarningsPrecautionsAdverse Reactions---
Omniscan (Gadodiamide) Injection-Contraindications------
Optimark (Gadoversetamide) Injection-Contraindications------
Xgeva (Denosumab) Injection-ContraindicationsWarningsPrecautions----
Ablavar (Gadofosveset Trisodium) Injection--WarningsPrecautions----
Avelox (Moxifloxacin Hydrochloride) Tablets and Injection--WarningsPrecautionsAdverse Reactions---
Cipro (Ciprofloxacin Hydrochloride) Tablets and Oral Suspension--WarningsPrecautionsAdverse Reactions---
Cipro IV (Ciprofloxacin Hydrochloride) Injection--WarningsPrecautionsAdverse Reactions---
Cipro XR (Ciprofloxacin extended-release) Tablets--WarningsPrecautionsAdverse Reactions---
Colyte (Peg-3350 & electrolytes) For oral solution--WarningsPrecautionsAdverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Daliresp (Roflumilast) Tablets--WarningsPrecautions----
Desoxyn (Methamphetamine Hydrochloride) Tablets--WarningsPrecautions----
Doxil (Doxorubicin HCL) Liposome Injection--WarningsPrecautionsAdverse Reactions---
Factive (Gemifloxacin Mesylate) Tablets--Warnings-----
Levaquin (Levofloxacin) Tablets, Oral Solution and Injection--WarningsPrecautionsAdverse Reactions---
Mirena (Levonorgestrel-Releasing Intrauterine System)--WarningsPrecautions----
Noroxin (Norfloxacin) Tablets--WarningsPrecautionsAdverse Reactions---
Quillivant XR (Methylphenidate) Extended-release Oral Suspension--WarningsPrecautions----
Relistor (Methylnaltrexone Bromide) Subcutaneous Injection--WarningsPrecautions----
Sutent (Sunitinib Malate) Capsules--WarningsPrecautionsAdverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Zevalin (Ibritumomab Tiuxetan) Injection--WarningsPrecautions----
Aerospan (flunisolilde) Inhalation Aerosol---Precautions----
Firmagon (Degarelix for injection)----Adverse Reactions---
Halaven (Eribulin Mesylate) Injection----Adverse Reactions---
Intuniv (Guanfacine) Extended-release Tablets----Adverse Reactions---
Reyataz (Atazanavir Sulfate) Capsules----Adverse Reactions---
Sirturo (Bedaquiline) Tablets--------
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