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Drug Safety Labeling Changes - April 2016

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April 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
Kadcyla (ado-trastuzumab emtansine) for Injection, for Intravenous Use Boxed Warning-------
Aciphex (rabeprazole sodium) Delayed-release Tablets, for Oral Use and Aciphex Sprinkle (rabeprazole sodium delayed-release capsules)-Contraindications------
Lopid (gemfibrozil Tablets, USP)-ContraindicationsWarningsPrecautions----
Ringer’s Injection, USP in VIAFLEX Plastic Container-ContraindicationsWarningsPrecautions----
Betaseron (interferon beta-1b) for Injection, for Subcutaneous Use--WarningsPrecautions----
Cimzia (certolizumab pegol) for Injection, for Subcutaneous Use --WarningsPrecautionsAdverse Reactions---
Cordarone (amiodarone HCl) Tablets--WarningsPrecautionsAdverse Reactions---
Gilotrif (afatinib) Tablets, for Oral Use--WarningsPrecautions----
Lenvima (lenvatinib) Capsules, for Oral Use--WarningsPrecautions----
Nesina (alogliptin) Tablets, for Oral Use--WarningsPrecautions----
Drug Name BW C W P AR PPI MG PCI
Onglyza (saxagliptin) Tablets, for Oral Use--WarningsPrecautions----
Oxaliplatin Injection for Intravenous Use--WarningsPrecautionsAdverse Reactions---
Precedex (dexmedetomidine hydrochloride) Injection and Precedex (dexmedetomidine hydrochloride) in 0.9% Sodium Chloride Injection--WarningsPrecautionsAdverse Reactions---
Skyla (levonorgestrel-releasing intrauterine system)--WarningsPrecautionsAdverse Reactions---
Vibramycin Monohydrate (doxycycline monohydrate) for Oral Suspension, Vibramycin Hyclate (doxycycline hyclate capsules, USP), Vibramycin Calcium (doxycycline calcium oral suspension) Syrup, Vibra-Tabs (doxycycline hyclate tablets, USP)--WarningsPrecautions----
Vibramycin (doxycycline hyclate) Intravenous--WarningsPrecautions----
Zonegran (zonisamide) Capsules, for Oral Administration--Warnings-----
Cialis (tadalafil) Tablets, For Oral Use---PrecautionsAdverse Reactions---
Limbitrol (chlordiazepoxide and amitriptyline HCI) and Limbitrol DS ---Precautions----
Nplate (romiplostim) for Injection, for Subcutaneous Use---PrecautionsAdverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Tivicay (dolutegravir) Tablets, For Oral Use---PrecautionsAdverse Reactions---
Triumeq (abacavir, dolutegravir, and lamivudine) Tablets, For Oral Use---PrecautionsAdverse Reactions---
Viekira PAK (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets), Co-packaged for Oral Use---Precautions----
Zestril (lisinopril) Tablets, for Oral Use---Precautions----
Cancidas (caspofungin acetate) for Injection, for Intravenous Use----Adverse Reactions---
Reclast (zoledronic acid) Injection----Adverse Reactions---
Victoza (liraglutide) Injection, for Subcutaneous Use----Adverse Reactions---
Wellbutrin and Wellbutrin SR (bupropion hydrochloride) Tablets, For Oral Use----Adverse Reactions---
Xalkori (crizotinib) Capsules, for Oral Use----Adverse Reactions---
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