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Drug Safety Labeling Changes - January 2016

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January 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
Gleostine (Lomustine) Capsules Boxed Warning-------
Lotronex (alosetron hydrochloride) Tablets Boxed Warning-------
Propylthiouracil TabletsBoxed Warning-WarningsPrecautions----
Topotecan InjectionBoxed Warning-------
Fanapt (iloperidone) Tablets  -Contraindications--Adverse Reactions---
Orbactiv (oritavancin diphosphate) Lyophilized Powder for Injection -ContraindicationsWarningsPrecautions----
Botox (onabotulinumtoxinA) --WarningsPrecautions----
Epaned (enalapril maleate) 1 mg/mL Powder (reconstituted) for Oral Solution --WarningsPrecautions----
Halaven (eribulin mesylate) Injection --WarningsPrecautions----
Kyprolis (carfilzomib) for Injection --WarningsPrecautions----
Drug Name BW C W P AR PPI MG PCI
Mavik (trandolapril) Tablets --WarningsPrecautions----
Miostat (carbachol intraocular solution, USP) --Warnings-Adverse Reactions---
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