Drug Safety Labeling Changes - June 2014

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June 2014

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
Sporanox (itraconazole) CapsulesBoxed WarningContraindicationsWarningsPrecautionsAdverse Reactions---
Sporanox (itraconazole) Oral SolutionBoxed WarningContraindicationsWarningsPrecautionsAdverse Reactions---
Alsuma (sumatriptan) injection-ContraindicationsWarningsPrecautions----
Androderm (testosterone) transdermal system--Warnings-Adverse Reactions---
AndroGel (testosterone) gel 1% and 1.62% --Warnings-Adverse Reactions---
Avalide (irbesartan and hydrochlorothiazide) tablets--WarningsPrecautions----
Aveed (testosterone undecanoate) injection --Warnings-Adverse Reactions---
Axiron (testosterone) topical solution--Warnings-Adverse Reactions---
Cleocin Phosphate (Clindamycin injection, USP) and (clindamycin injection in 5 percent dextrose)--WarningsPrecautionsAdverse Reactions---
Cleocin HCL (clindamycin hydrochloride) Capsules--WarningsPrecautionsAdverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Complera (emtricitabine, rilpivirine, tenofovir disoproxilfumarate) tablets, for oral use--WarningsPrecautions----
Delatestryl (testosterone enanthate) injection--Warnings-Adverse Reactions---
Ella (ulipristal acetate) tablet--WarningsPrecautions----
Fortesta (testosterone) gel--Warnings-Adverse Reactions---
Gazyva (obinutuzumab) Injection--WarningsPrecautions----
Herceptin (trastuzumab) Intravenous Infusion--WarningsPrecautionsAdverse Reactions---
Lupron Depot (leuprolide acetate) for depot suspension--WarningsPrecautions----
Nutropin AQ (somatropin [rDNA origin]) for injection --WarningsPrecautions----
Prolia (denosumab) Injection--WarningsPrecautions----
Saizen (somatropin [rDNA origin]) for injection--WarningsPrecautions----
Drug Name BW C W P AR PPI MG PCI
Serostim (somatropin [rDNA origin] for injection)--WarningsPrecautions----
Striant (testosterone) buccal system--Warnings-Adverse Reactions---
Sutent (sunitinib malate) capsules, oral--WarningsPrecautions----
Symlin (pramlintide acetate) injection--WarningsPrecautionsAdverse Reactions---
Testim (testosterone) gel--Warnings-Adverse Reactions---
Testosterone gel--Warnings-Adverse Reactions---
Thalomid (thalidomide) capsules--WarningsPrecautions----
Trileptal (oxcarbazepine) film-coated tablets and oral suspension--WarningsPrecautions----
Xgeva (denosumab) injection for subcutaneous use--WarningsPrecautions----
Zestril (lisinopril) tablets--WarningsPrecautionsAdverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Benicar (olmesartan medoxomil) tablets, for oral use---PrecautionsAdverse Reactions---
Benicar HCT (olmesartan medoxomil-hydrochlorothiazide) tablets---PrecautionsAdverse Reactions---
Caverject (alprostadil for injection)---Precautions----
Caverject Impulse Dual Chamber System (alprostadil for injection)  ---Precautions----
Cerebyx (Fosphenytoin Sodium Injection)---Precautions----
Comtan (entacapone) Tablets---Precautions----
Hycamtin (topotecan) capsules---Precautions----
Jetrea (ocriplasmin) Intravitreal Injection, 2.5 mg/mL---Precautions----
Ravicti (glycerol phenylbutyrate) Oral Liquid---Precautions----
Tev-Tropin (somatropin [rDNA origin]) for injection ---Precautions----
Drug Name BW C W P AR PPI MG PCI
Tribenzor (olmesartan medoxomil, amlodipine, hydrochlorothiazide) Tablets---PrecautionsAdverse Reactions---
Votrient (pazopanib) tablets---Precautions----
Adagen (pegademase bovine) Injection----Adverse Reactions---
Azor (amlodipine and olmesartan medoxomil) tablets, for oral use----Adverse Reactions---
Depakene (valproic acid) CapsulesDepakene (valproic acid) Oral SolutionDepakote (divalproex sodium) Delayed ReleaseDepakote Sprinkle Capsules (divalproex sodium coated particles in capsules)Depacon (valproate sodium) InjectionDepakote ER (divalproex sodium) Extended Release Tablets----Adverse Reactions---
Gattex (teduglutide [rDNA origin]) for subcutaneous injection----Adverse Reactions---
Increlex (mecasermin [rDNA origin]) injection----Adverse Reactions---
Micronor (norethindrone) Tablets----Adverse Reactions---
NuvaRing (etonogestrel/ethinyl estradiol) vaginal ring----Adverse Reactions---
Vistaril (hydroxyzine pamoate) capsules and oral suspension----Adverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Alli (orlistat) capsules--------
Lamictal (lamotrigine) tabletsLamictal (lamotrigine) chewable dispersible tabletsLamictal ODT (lamotrigine) orally disintegrating tabletsLamictal XR (lamotrigine) extended-release tablets--------
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