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September 2014

Drug Safety Labeling Changes

The summary view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. The “quick view” table below provides the drug name and sections modified. Click on the drug name to go to the detailed view. The detailed view includes sections and subsections modified, a description of new or modified safety information in the BOXED WARNING, CONTRAINDICATIONS, or WARNINGS sections, and a link to the revised prescribing information.

Key to Label Section Acronyms:

BW=BOXED WARNING, C=CONTRAINDICATIONS, W=WARNINGS, P=PRECAUTIONS
AR=ADVERSE REACTIONS, PPI/MG=PATIENT PACKAGE INSERT/MEDICATION GUIDE

DRUG NAME	SECTIONS MODIFIED
(Click on drug name to go to detailed view)	BW	C	W	P	AR	PPI/MG
Lumizyme (aglucosidase alfa)	X		X	X	X	PCI
Pegasys (peginterferon alfa-2a)	X	X	X	X		MG
Revlimid (lenalidomide) Capsules 2.5, 5, 10, 15, 20, and 25 mg	X		X	X		PCI
Xylocaine Viscous (lidocaine HCl) Solution, 2 percent	X		X	X
(Click on drug name to go to detailed view)	BW	C	W	P	AR	PPI/MG
Arthrotec (diclofenac sodium/misoprostol) Oral Tablets		X	X	X	X
Halcion (triazolam) tablets, 0.25 mg		X	X	X
Ozurdex (dexamethasone intravitreal implant) 0.7 mg		X	X	X		MG
(Click on drug name to go to detailed view)	BW	C	W	P	AR	PPI/MG
Aloxi (palonosetron hydrochloride) Injection *Serotonin Syndrome			X	X		PCI
Aloxi (palonosetron hydrochloride) Oral Capsules *Serotonin Syndrome			X	X		PCI
Anzemet (dolasetron mesylate) injection, 20 mg/mL *Serotonin Syndrome			X	X		PCI
Anzemet (dolasetron mesylate) tablets, 50 mg and 100 mg *Serotonin Syndrome			X	X		PCI
Chantix (varenicline) Tablets; 0.5 mg and 1 mg			X	X	X
Clolar (clofarabine) Injection, 1 mg/mL			X	X	X
Docetaxel Injection Concentrate, 20 mg/1 mL, 80 mg/4 mL, and 140 mg/7 mL			X	X	X
Genotropin (somatropin [rDNA origin] for injection)			X	X
Hyzaar (losartan potassium/hydrochlorothiazide) 50/12.5 mg, 100/12.5 mg, and 100/25 mg Tablets			X	X
Latisse (bimatoprost ophthalmic solution), 0.03 percent			X	X	X	PCI
Lexiscan (regadenoson) Injection			X	X	X	PCI
Lumigan (bimatoprost ophthalmic solution), 0.03 percent			X	X
Lumigan (bimatoprost ophthalmic solution), 0.01 percent			X	X	X
MembraneBlue (trypan blue ophthalmic solution) 0.15 percent			X	X
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			X	X	X
Norditropin Cartridges (somatropin [rDNA origin] injection)			X	X
Sancuso (granisetron) *Serotonin Syndrome			X	X		PCI
Vibramycin (doxycycline hyclate) Intravenous			X
Vibramycin Monohydrate (doxycycline monohydrate) for Oral Suspension Vibramycin (doxycycline hyclate) Capsules Vibramycin Calcium (doxycycline calcium oral suspension) Syrup Vibra-Tabs (doxycycline hyclate) Film Coated Tablets			X
Xolair (omalizumab)			X	X		MG
Zofran (ondansetron hydrochloride) Injection *Serotonin Syndrome			X	X		PCI
Zofran (ondansetron hydrochloride) Tablets *Serotonin Syndrome			X	X		PCI
Zofran (ondansetron hydrochloride) Oral Solution *Serotonin Syndrome			X	X		PCI
Zofran ODT (ondansetron) Orally Disintegrating Tablets *Serotonin Syndrome			X	X		PCI
Zuplenz (ondansetron) oral soluble film *Serotonin Syndrome			X	X		PCI
(Click on drug name to go to detailed view)	BW	C	W	P	AR	PPI/MG
Azor (amlodipine/olmesartan medoxomil) 5/20 mg, 10/20 mg, 5/40 mg, and 10/40 mg Tablets * RAS Dual Blockade				X
Benicar (olmesartan medoxomil) 5 mg, 20 mg, and 40 mg Tablets * RAS Dual Blockade				X
Benicar HCT (olmesartan medoxomil/hydrochlorothiazide) 20/12.5 mg, and 40.12.5 mg, and 40/25 mg Tablets * RAS Dual Blockade				X
Cozaar (losartan potassium) 25 mg, 50 mg, and 100 mg Tablets				X		PI
Diovan (valsartan) 80 mg and 160 mg Capsules * RAS Dual Blockade				X
Diovan (valsartan) 40 mg, 80 mg, 160 mg, and 320 mg Tablets * RAS Dual Blockade				X
Emsam (Selegiline Transdermal System) 6 mg/24 hours, 9 mg/24 hours, and 12 mg/24 hours				X		PCI
Exforge (amlodipine/valsartan) 5/160 mg, 10/160 mg, 5/320 mg, and 10/320 mg Tablets * RAS Dual Blockade				X
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 * RAS Dual Blockade				X
Fosrenol (lanthanum carbonate) chewable tablets 500 mg, 750 mg and 1000 mg				X
Namenda XR (memantine hydrochloride extended-release) Capsule, 7 mg, 14 mg, 21 mg, and 28 mg				X	X
Nulojix (belatacept)				X
Olysio (simeprevir), 150 mg capsules				X
Qsymia (phentermine and topiramate extended-release) capsules				X	X
Tasigna (nilotinib) capsules, 150 and 200 mg				X
Tegretol (carbamazepine) Tablets, Chewable Tablets, Oral Suspension, Tegretol-XR (carbamazepine extended-release)				X	X
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 * RAS Dual Blockade				X
Velphoro (sucroferric oxyhydroxide) Chewable Tablets, 500 mg Iron				X		PCI
Zoloft (sertraline hydrochloride) 20mg/mL Oral Concentrate				X
(Click on drug name to go to detailed view)	BW	C	W	P	AR	PPI/MG
Clozaril (clozapine) 25 mg and 100 mg tablets					X
Invanz (ertapenem) Injection, 1 gm					X
Megace ES (megestrol acetate) oral suspension, 125 mg/mL					X
Pradaxa (dabigatran etexilate mesylate) 75 and 150 mg Capsules					X
(Click on drug name to go to detailed view)	BW	C	W	P	AR	PPI/MG

September 2014

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