Drug Safety Labeling Changes - September 2014

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September 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
Lumizyme (aglucosidase alfa)Boxed Warning-WarningsPrecautionsAdverse Reactions---
Pegasys (peginterferon alfa-2a)Boxed WarningContraindicationsWarningsPrecautions----
Revlimid (lenalidomide) Capsules 2.5, 5, 10, 15, 20, and 25 mgBoxed Warning-WarningsPrecautions----
Xylocaine Viscous (lidocaine HCl) Solution, 2 percentBoxed Warning-WarningsPrecautions----
Arthrotec (diclofenac sodium/misoprostol) Oral Tablets -ContraindicationsWarningsPrecautionsAdverse Reactions---
Halcion (triazolam) tablets, 0.25 mg-ContraindicationsWarningsPrecautions----
Ozurdex (dexamethasone intravitreal implant) 0.7 mg-ContraindicationsWarningsPrecautions----
Aloxi (palonosetron hydrochloride) Injection--WarningsPrecautions----
Aloxi (palonosetron hydrochloride) Oral Capsules--WarningsPrecautions----
Anzemet (dolasetron mesylate) injection, 20 mg/mL--WarningsPrecautions----
Drug Name BW C W P AR PPI MG PCI
Anzemet (dolasetron mesylate) tablets, 50 mg and 100 mg--WarningsPrecautions----
Chantix (varenicline) Tablets; 0.5 mg and 1 mg--WarningsPrecautionsAdverse Reactions---
Clolar (clofarabine) Injection, 1 mg/mL--WarningsPrecautionsAdverse Reactions---
Docetaxel Injection Concentrate, 20 mg/1 mL, 80 mg/4 mL, and 140 mg/7 mL--WarningsPrecautionsAdverse Reactions---
Genotropin (somatropin [rDNA origin] for injection)--WarningsPrecautions----
Hyzaar (losartan potassium/hydrochlorothiazide) 50/12.5 mg, 100/12.5 mg, and 100/25 mg Tablets--WarningsPrecautions----
Latisse  (bimatoprost ophthalmic solution), 0.03 percent--WarningsPrecautionsAdverse Reactions---
Lexiscan (regadenoson) Injection--WarningsPrecautionsAdverse Reactions---
Lumigan (bimatoprost ophthalmic solution), 0.03 percent--WarningsPrecautions----
Lumigan (bimatoprost ophthalmic solution), 0.01 percent--WarningsPrecautionsAdverse Reactions---
Drug Name BW C W P AR PPI MG PCI
MembraneBlue (trypan blue ophthalmic solution) 0.15 percent--WarningsPrecautions----
Minivelle (estradiol transdermal system) 0.025 mg/day, 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day, and 0.1 mg/day--WarningsPrecautionsAdverse Reactions---
Norditropin Cartridges (somatropin [rDNA origin] injection)--WarningsPrecautions----
Sancuso (granisetron)--WarningsPrecautions----
Vibramycin (doxycycline hyclate) Intravenous--Warnings-----
Vibramycin Monohydrate (doxycycline monohydrate) for Oral Suspension Vibramycin (doxycycline hyclate) CapsulesVibramycin Calcium (doxycycline calcium oral suspension) SyrupVibra-Tabs (doxycycline hyclate) Film Coated Tablets--Warnings-----
Xolair (omalizumab)--WarningsPrecautions----
Zofran (ondansetron hydrochloride) Injection --WarningsPrecautions----
Zofran (ondansetron hydrochloride) Tablets--WarningsPrecautions----
Zofran (ondansetron hydrochloride) Oral Solution--WarningsPrecautions----
Drug Name BW C W P AR PPI MG PCI
Zofran ODT (ondansetron) Orally Disintegrating Tablets--WarningsPrecautions----
Zuplenz (ondansetron) oral soluble film--WarningsPrecautions----
Azor (amlodipine/olmesartan medoxomil) 5/20 mg, 10/20 mg, 5/40 mg, and 10/40 mg Tablets ---Precautions----
Benicar (olmesartan medoxomil) 5 mg, 20 mg, and 40 mg Tablets---Precautions----
Benicar HCT (olmesartan medoxomil/hydrochlorothiazide) 20/12.5 mg, and 40.12.5 mg, and 40/25 mg Tablets---Precautions----
Cozaar (losartan potassium) 25 mg, 50 mg, and 100 mg Tablets---Precautions----
Diovan (valsartan) 80 mg and 160 mg Capsules---Precautions----
Diovan (valsartan) 40 mg, 80 mg, 160 mg, and 320 mg Tablets---Precautions----
Emsam (Selegiline Transdermal System) 6 mg/24 hours, 9 mg/24 hours, and 12 mg/24 hours ---Precautions----
Exforge (amlodipine/valsartan) 5/160 mg, 10/160 mg, 5/320 mg, and 10/320 mg Tablets ---Precautions----
Drug Name BW C W P AR PPI MG PCI
Exforge HCT (amlodipine/valsartan/hydrochlorothiazide) 5/160/12.5 mg, 10/160/12.5 mg, 5/160/25 mg, 10/160/25 mg, and 10/320/25 mg Tablets---Precautions----
Fosrenol (lanthanum carbonate) chewable tablets 500 mg, 750 mg and 1000 mg ---Precautions----
Namenda XR (memantine hydrochloride extended-release) Capsule, 7 mg, 14 mg, 21 mg, and 28 mg---PrecautionsAdverse Reactions---
Nulojix (belatacept) ---Precautions----
Olysio (simeprevir), 150 mg capsules---Precautions----
Qsymia (phentermine and topiramate extended-release) capsules---PrecautionsAdverse Reactions---
Tasigna (nilotinib) capsules, 150 and 200 mg---Precautions----
Tegretol (carbamazepine) Tablets, Chewable Tablets, Oral Suspension,---PrecautionsAdverse Reactions---
Tegretol-XR (carbamazepine extended-release)  ---PrecautionsAdverse Reactions---
Tribenzor (olmesartan /medoxomil / amlodipine / hydrochlorothiazide) 20/5/12.5 mg, 40/5/25 mg, 40/10/12.5 mg, and 40/10/25 mg Tablets---Precautions----
Drug Name BW C W P AR PPI MG PCI
Velphoro (sucroferric oxyhydroxide) Chewable Tablets, 500 mg Iron ---Precautions----
Zoloft (sertraline hydrochloride) 20mg/mL Oral Concentrate---Precautions----
Clozaril (clozapine) 25 mg and 100 mg tablets----Adverse Reactions---
Invanz (ertapenem) Injection, 1 gm----Adverse Reactions---
Megace ES (megestrol acetate) oral suspension, 125 mg/mL ----Adverse Reactions---
Pradaxa (dabigatran etexilate mesylate) 75 and 150 mg Capsules----Adverse Reactions---
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