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Drug Safety Labeling Changes - July 2015

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July 2015

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
Droxia (hydroxyurea)Boxed Warning-------
Dysport (abobotulinumtoxinA) InjectionBoxed Warning-------
Ortho Tri-Cyclen Lo (norgestimate/ethinyl estradiol) TabletsBoxed Warning-------
Lantus (insulin glargine injection)-ContraindicationsWarningsPrecautionsAdverse Reactions---
Stribild (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate) Tablets-Contraindications------
Viekira Pak (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets), Copackaged for Oral Use-Contraindications-Precautions----
Aczone (dapsone topical gel) 5 %--WarningsPrecautions----
Aranesp (darbepoetin alfa)--WarningsPrecautions----
Cellcept (Mycophenolate Mofetil) Capsules Cellcept (Mycophenolate Mofetil) Tablets Cellcept (Mycophenolate Mofetil) HCL) Injection Cellcept (Mycophenolate Mofetil) Oral Suspension--WarningsPrecautionsAdverse Reactions---
Ceftriaxone for Injection and Dextrose Injection, for Intravenous Use--WarningsPrecautionsAdverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Etopophos (etoposide phosphate) for Injection--WarningsPrecautions----
Evotaz (atazanavir/cobicistat) Tablets--WarningsPrecautions----
Exjade (deferasirox) Tablets--WarningsPrecautionsAdverse Reactions---
Gelnique (oxybutynin chloride), 3 percent gel  --Warnings-Adverse Reactions---
Gelnique (oxybutynin chloride), 10 percent gel  --Warnings-Adverse Reactions---
Gilenya (fingolimod) Capsules--WarningsPrecautions----
Lotensin (benazepril) Tablets--WarningsPrecautionsAdverse Reactions---
Neupogen (filgrastim)--WarningsPrecautionsAdverse Reactions---
Oxytrol (oxybutynin transdermal system)--Warnings-Adverse Reactions---
Prinivil (lisinopril) Tablets--WarningsPrecautionsAdverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Zykadia (ceritinib) Capsules--WarningsPrecautionsAdverse Reactions---
Zyprexa (olanzapine) Tablets--WarningsPrecautions----
Zyprexa Zydis (olanzapine) Orally Disintegrating Tablets--WarningsPrecautions----
Zyprex Intramuscular (olanzapine) --WarningsPrecautions----
Zyprexa Relprevv (olanzapine) For Extended Release Injectable Suspension --WarningsPrecautions----
Aricept (donepezil HCl) Tablet Aricept ODT (donepezil HCl) Tablet Aricept (donepezil HCl) Film Coated Tablet---Precautions----
Auryxia (ferric citrate) Tablets---Precautions----
Digoxin 0.05 mg/mL Oral Solution USP---Precautions----
Diovan (valsartan) Capsules Diovan (valsartan) Tablets Diovan HCT (valsartan/hydrochlorothiazide) Tablets---Precautions----
Eylea (aflibercept) Injection---Precautions----
Drug Name BW C W P AR PPI MG PCI
Exforge (amlodipine/valsartan) Tablets---Precautions----
Exforge HCT (amlodipine/valsartan/hydrochlorothiazide) Tablets---Precautions----
Lanoxin (digoxin) Tablets---Precautions----
Lanoxin (digoxin) Injection Lanoxin (digoxin) Injection Pediatric ---Precautions----
Lexiva (fosamprenavir calcium) Tablets and Oral Solution---Precautions----
Vitekta (elvitegravir) Tablet---Precautions----
Zmax (azithromycin extended release) for Oral Suspension---PrecautionsAdverse Reactions---
Agrylin (anagrelide hydrochloride) Capsules----Adverse Reactions---
Cholografin Meglumine (iodipamide meglumine) Injection----Adverse Reactions---
Cleocin Vaginal Cream Cleocin Vaginal Ovules----Adverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Conray (Iothalamate Meglumine) Injection Conray 43 (Iothalamate Meglumine) Injection Conray 30 (Iothalamate Meglumine) Injection ----Adverse Reactions---
Cystografin (diatrizoate meglumine) Injection Cystografin Dilute (diatrizoate meglumine) Injection----Adverse Reactions---
Hexabrix (ioxaglate meglumine 39.3%; ioxaglate sodium 19.6%) Injection----Adverse Reactions---
Isovue (iopamidol) Injection Isovue-M (iopamidol) Injection Isovue (iopamidol) Injection Pharmacy Bulk Pack and Imaging Bulk Pack----Adverse Reactions---
Jentadueto (linagliptin and metformin hydrochloride) Tablets----Adverse Reactions---
MD-76R (Diatrizoate Meglumine; Diatrizoate Sodium) Injection----Adverse Reactions---
Mycobutin (rifabutin) Capsules----Adverse Reactions---
Omnipaque (iohexol) Injection Omnipaque (iohexol) Injection Pharmacy Bulk Pack----Adverse Reactions---
Optiray (ioversol) Injection Optiray (ioversol) Injection Pharmacy Bulk Package----Adverse Reactions---
Plavix (clopidogrel bisulfate) Tablets----Adverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Tradjenta (linagliptin) Tablets----Adverse Reactions---
Ultravist (iopromide) Injection Ultravist (iopromide) Injection Pharmacy Bulk Pack----Adverse Reactions---
Visipaque (iodixanol) Injection Visipaque (iodixanol) Injection Pharmacy Bulk Pack----Adverse Reactions---
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