Drug Safety Labeling Changes - April 2013

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April 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
Ambien (Zolpidem Tartrate) Tablets-ContraindicationsWarningsPrecautionsAdverse Reactions---
Ambien CR (Zolpidem Tartrate) Extended-release Tablets-ContraindicationsWarningsPrecautionsAdverse Reactions---
Atacand (Candesartan Cilexetil) Tablets-ContraindicationsWarningsPrecautionsAdverse Reactions---
Atacand HCT (Candesartan Cilexetil/Hydrodchlorothiazide) Tablets-ContraindicationsWarningsPrecautionsAdverse Reactions---
Boniva (Ibandronate) Injection-ContraindicationsWarningsPrecautionsAdverse Reactions---
Dificid (Fidaxomicin) Tablets-ContraindicationsWarningsPrecautions----
Jalyn (Dutasteride and Tamsulosin Hydrochloride) Capsules-ContraindicationsWarningsPrecautionsAdverse Reactions---
Amrix (Cyclobenzaprine Hydrochloride) Extended-Release Capsules--WarningsPrecautions----
Atripla (Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate) Tablets--WarningsPrecautions----
Coartem (Artemether/Lumefantrine) Tablets--WarningsPrecautions----
Drug Name BW C W P AR PPI MG PCI
Edluar (Zolpidem Tartrate) Sublingual Tablets--WarningsPrecautions----
Emtriva (Emtricitabine) Capsulests and Oral Solution--WarningsPrecautions-Patient Package Insert--
Flexeril (Cyclobenzaprine Hydrochloride) Tablets--WarningsPrecautionsAdverse Reactions---
Incivek (Telaprevir) Film Coated Tablets--WarningsPrecautions----
Nulojix (Belatacept) Intravenous Injection--WarningsPrecautions----
Qualaquin (Quinine Sulfate) Capsules--WarningsPrecautions----
Samsca (Tolvaptan) Tablets--WarningsPrecautionsAdverse Reactions---
Seroquel XR (Quetiapine fumarate) Extended-release Tablets--WarningsPrecautions----
Supprelin LA (Histrelin Acetate) Subcutaneous Implant--WarningsPrecautionsAdverse Reactions---
Victozo (Liraglutide [rDNA orgin]) Injection--WarningsPrecautions----
Drug Name BW C W P AR PPI MG PCI
Victoza (Liraglutide [rDNA orgin]) Injection--WarningsPrecautions----
Viread (Tenofovir Disoprixil Fumarate) Tablets and Oral Powder--WarningsPrecautions----
Actonel (Risedronate Sodium) Tablets---PrecautionsAdverse Reactions---
Actonel with Calcium (Risedronate Sodium with Calcium Carbonate) Tablets---PrecautionsAdverse Reactions---
Atelvia (Risedronate Sodium) Delayed-release Tablets---PrecautionsAdverse Reactions---
Binosto (Alendronate Sodium) Effervescent Tablets---PrecautionsAdverse Reactions---
Boniva (Ibandronate Sodium) Tablets---PrecautionsAdverse Reactions---
Cogentin (Benztropine Mesylate) Injection---Precautions----
Didronel (Itidronate Disodium) Tablets ---PrecautionsAdverse Reactions---
Fosamax (Alendronate Sodium) Tablets and Oral Solution---PrecautionsAdverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Aldurazyme (Laronidase) Solution for Intravenous Infusion----Adverse Reactions---
Avodart (Dutasteride) Gelatin Capsules----Adverse Reactions---
Differin (Adapalene) Lotion----Adverse Reactions---
Doribax (Doripenem) For Injection----Adverse Reactions---
Famvir (Famciclovir) Tablets----Adverse Reactions---
Sonata (Zaleplon) Capsules----Adverse Reactions---
Stelara (Ustekinumab) Injection----Adverse Reactions---
Tyvaso (Treprostinil) Inhalation Solution----Adverse Reactions---
Vimpat (Lacosamide) Tablets, Injection and Oral Solution----Adverse Reactions---
Xeomin (Incobotulinumtoxin A) for Injection----Adverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Zenpep (Pancrelipase) Delayed-release Capsules----Adverse Reactions---
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