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Drug Safety Labeling Changes - March 2015

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March 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
Bydureon (exenatide extended-release) for Injectable SuspensionBoxed Warning-WarningsPrecautions----
Estrasorb (estradiol) topical emulsionBoxed WarningContraindicationsWarningsPrecautionsAdverse Reactions---
Feraheme (ferumoxytol) InjectionBoxed WarningContraindicationsWarningsPrecautionsAdverse Reactions---
Tanzeum (albiglutide) Injection, for Subcutaneous UseBoxed Warning-WarningsPrecautions----
Trulicity (dulaglutide) Injection, for Subcutaneous UseBoxed Warning-WarningsPrecautions----
Victoza (liraglutide [rDNA origin]) injection) Solution for Subcutaneous UseBoxed Warning-WarningsPrecautions----
Atelvia (risedronate sodium) Delayed-release TabletsActonel with Calcium (risedronate sodium tablets with calcium carbonate) TabletsActonel (risedronate sodium) Tablets-Contraindications--Adverse Reactions---
Avandaryl (rosiglitazone maleate and glimepiride) Tablets-ContraindicationsWarningsPrecautionsAdverse Reactions---
Cenestin (Synthetic Conjugated Estrogens, A) Tablets -ContraindicationsWarningsPrecautions----
Duetact (pioglitazone hydrochloride and glimepiride) Tablets-ContraindicationsWarningsPrecautionsAdverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Edex (alprostadil) for Injection-Contraindications------
Amturnide (aliskiren/amlodipine besylate/hydrochlorothiazide) Tablets--WarningsPrecautionsAdverse Reactions---
Aptivus (tipranavir) Capsules, Oral Solution --------
Breo Ellipta (fluticasone furoate and vilanterol) inhalation powder--WarningsPrecautions----
Cardizem LA (diltiazem hydrochloride) Extended Release Tablets--WarningsPrecautions----
Cefobid (sterile cefoperazone) Injection--Warnings-Adverse Reactions---
Cordarone (amiodarone hydrochloride) Tablets--WarningsPrecautions----
Crixivan (indinavir sulfate) Capsules--WarningsPrecautions----
Dovonex (calcipotriene cream) Cream and Ointment--Warnings-Adverse Reactions---
Ella (ulipristal acetate) Tablets--WarningsPrecautions----
Drug Name BW C W P AR PPI MG PCI
Erbitux (cetuximab) Injection for Intravenous Infusion--WarningsPrecautionsAdverse Reactions---
Harvoni (ledipasvir/sofosbuvir) Fixed-dose Combination Tablet--WarningsPrecautionsAdverse Reactions---
Invirase (saquinavir mesylate) Capsules, Tablets--WarningsPrecautions----
Kaletra (lopinavir/ritonavir) Oral Solution, Tablets, Capsules--WarningsPrecautions----
Keppra (levetiracetam) Tablets, Oral Solution, Extended-release Tablets--WarningsPrecautionsAdverse Reactions---
Kyprolis (carfilzomib) for Injection--WarningsPrecautions----
Lamictal (lamotrigine) Tablets, Chewable Dispersible Tablets, Orally Disintegrating Tablets, Extended-release Tablets--WarningsPrecautionsAdverse Reactions---
Lexiva (fosamprenavir calcium) Tablets, Oral Suspension--WarningsPrecautions----
Minocin (minocycline hydrochloride) Pellet-filled Capsules--Warnings-----
Nexterone (amiodarone) Premixed Injection--WarningsPrecautionsAdverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Norvir (ritonavir) Capsules, Oral Solution, Tablets--WarningsPrecautions----
Pegasys (peginterferon alfa-2a) Injection, for Subcutaneous Use --WarningsPrecautionsAdverse Reactions---
Prezista (darunavir) Tablets, Oral Suspension--WarningsPrecautions----
Reyataz (atazanavir) Capsules, Oral Powder--WarningsPrecautions----
Sovaldi (sofosbuvir) Tablet--WarningsPrecautionsAdverse Reactions---
Tekamlo (aliskiren/amlodipine besylate) Tablets--WarningsPrecautionsAdverse Reactions---
Tekturna (aliskiren) Tablets--WarningsPrecautionsAdverse Reactions---
Tekturna HCT (aliskiren/hydrochlorothiazide) Tablets--WarningsPrecautionsAdverse Reactions---
Vectibix (panitumumab) Injection for Intravenous Infusion--WarningsPrecautions----
Viagra (sildenafil citrate) Tablets, for Oral Use--WarningsPrecautions----
Drug Name BW C W P AR PPI MG PCI
Viracept (nelfinavir mesylate) Oral Powder, Tablets--WarningsPrecautions----
Votrient (pazopanib) Tablets--WarningsPrecautionsAdverse Reactions---
Ziagen (abacavir sulfate) Tablets, Oral Solution--WarningsPrecautions----
Aceon (perindopril erbumine) Tablets---Precautions----
Caduet (atorvastatin/amlodipine) Tablets---PrecautionsAdverse Reactions---
Claforan (cefotaxime) InjectionClaforan (cefotaxime sodium) Sterile IM/IV---Precautions----
Kalydeco (ivacaftor) Tablets---Precautions----
Kepivance (palifermin) Injection---Precautions----
Neoral (cyclosporine) Soft Gelatin Capsules, Oral Solution---PrecautionsAdverse Reactions---
Norvasc (amlodipine besylate) Tablets---PrecautionsAdverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Norvir (ritonavir) Tablets, Oral Solution, Soft Gelatin Capsules---Precautions----
Precose (acarbose) Tablets---Precautions----
Sandimmune (cyclosporine injection) Injection, Oral Solution, Soft Gelatin Capsules---PrecautionsAdverse Reactions---
Sustiva (efavirenz) Capsules, Tablets ---Precautions----
Xopenex HFA (levalbuterol tartrate) Inhalation Aerosol---Precautions----
Boniva (ibandronate sodium) Tablets----Adverse Reactions---
Coartem (artemether/lumefantrine) Tablets----Adverse Reactions---
Depakene (valproic acid) capsules, oral solution, delayed release tablets Depakote Sprinkle Capsules (divalproex sodium) delayed release capsulesDepacon (valproate sodium) InjectionDepakote ER (divalproex sodium) extended release tablets----Adverse Reactions---
Didronel (etidronate disodium) Tablets----Adverse Reactions---
Invokamet (canagliflozin and metformin HCl) Tablets----Adverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Invokana (canagliflozin) Tablets----Adverse Reactions---
Lipitor (atorvastatin calcium) Tablets----Adverse Reactions---
Rapamune (sirolimus) Oral Solution, Tablets----Adverse Reactions---
Rebif (interferon beta-1a) Injection----Adverse Reactions---
Saphris (asenapine) Sublingual Tablets----Adverse Reactions---
Xeloda (capecitabine) Tablets----Adverse Reactions---
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