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Drug Safety Labeling Changes - March 2016

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March 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
Invega (paliperidone) Extended-Release Tablets-Contraindications------
Invega Sustenna (paliperidone palmitate) Extended-release Injectable Suspension-Contraindications------
Invega Trinza (paliperidone palmitate) Extended-release Injectable Suspension-Contraindications------
Invokamet (canagliflozin and metformin hydrochloride) Tablets-ContraindicationsWarningsPrecautionsAdverse Reactions---
Invokana (canagliflozin) Tablets-ContraindicationsWarningsPrecautionsAdverse Reactions---
PLASMA-LYTE 56 and 5% Dextrose Injection-Contraindications-Precautions----
Renagel (sevelamer hydrochloride) Tablets-Contraindications--Adverse Reactions---
Renvela (sevelamer carbonate) Powder for Oral Suspension-Contraindications--Adverse Reactions---
Risperdal (risperidone) Tablets, Oral Solution and Risperdal M-TAB (risperidone) Orally Disintegrating Tablets-Contraindications------
Risperdal Consta (risperidone) Long Acting Injection-Contraindications------
Drug Name BW C W P AR PPI MG PCI
Tudorza Pressair (aclidinium bromide inhalation powder) -ContraindicationsWarningsPrecautionsAdverse Reactions---
Adcetris (brentuximab vedotin) for Injection--WarningsPrecautions----
Angiomax (bivalirudin) Lyophilized Powder for Injection--WarningsPrecautionsAdverse Reactions---
Droxia (hydroxyurea) and Hydrea (hydroxyurea) Capsules--WarningsPrecautionsAdverse Reactions---
Faslodex (fulvestrant) Solution for Injection--WarningsPrecautions----
Herceptin (trastuzumab) Intravenous Infusion--WarningsPrecautionsAdverse Reactions---
Implanon (etonogestrel) Implant--WarningsPrecautionsAdverse Reactions---
Jakafi (ruxolitinib phosphate) Tablet--WarningsPrecautions----
Juxtapid (lomitapide) Capsules--WarningsPrecautions----
Nexplanon (etonogestrel) Implants--WarningsPrecautionsAdverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Oxytrol for Women (oxybutynin) Transdermal System--Warnings-----
Truvada (emtricitabine/tenofovir disoproxil fumarate) Tablets--WarningsPrecautions----
Xgeva (denosumab, AMG 162; Human Monoclonal Antibody to RANK Ligand)--WarningsPrecautionsAdverse Reactions---
Zarxio (filgrastim-sndz)--WarningsPrecautionsAdverse Reactions---
Furosemide Tablets, Injection and  Lasix (furosemide) Tablets---Precautions----
Genvoya (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) Fixed-dose Combination Tablet---Precautions----
Klonopin (clonazepam) Tablets---Precautions----
Prezcobix (darunavir and cobicistat) Tablet---Precautions----
Sustiva (efavirenz) Capsules and Tablets---Precautions----
Cleocin HCl (clindamycin hydrochloride) Capsules----Adverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Cleocin Phosphate (clindamycin) Injection and (clindamycin injection in 5% dextrose) Solution in Galaxy Plastic Containers ----Adverse Reactions---
Increlex (mecasermin [rDNA origin] injection)----Adverse Reactions---
Jetrea (ocriplasmin intravitreal) Injection----Adverse Reactions---
Zaltrap (ziv-aflibercept) Injection----Adverse Reactions---
Zometa (zoledronic acid) Injection----Adverse Reactions---
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