Drug Safety Labeling Changes - May 2013

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May 2013

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
Codeine Sulfate Solution Boxed WarningContraindicationsWarningsPrecautions----
Codeine Sulfate TabletsBoxed WarningContraindicationsWarningsPrecautions----
Fiorinal with Codeine (butalbital, aspirin, caffeine, and codeine phosphate, USP) CapsulesBoxed WarningContraindicationsWarningsPrecautions----
Promethazine and Codeine SyrupBoxed WarningContraindicationsWarningsPrecautions----
Promethazine, Phenylephrine and Codeine SyrupBoxed WarningContraindicationsWarningsPrecautions----
Soma Compound with Codeine (carisoprodol, aspirin, and codeine phosphate) TabletsBoxed WarningContraindicationsWarningsPrecautions----
SynalgosDC (dihydrocodeine bitartrate, aspirin and caffeine) CapsulesBoxed WarningContraindicationsWarningsPrecautions----
Vivelle-Dot (estradiol transdermal system)Boxed WarningContraindicationsWarningsPrecautionsAdverse Reactions---
Kombiglyze XR (saxagliptin + metformin XR FDC) tablets-Contraindications-PrecautionsAdverse Reactions---
Onglyza (saxagliptin)-Contraindications-PrecautionsAdverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Dyna-Hex 0.75 (chlorhexidine gluconate 0.75% solution)--Warnings-----
Gemzar (Gemcitabine for injection), 1g and 200 mg--WarningsPrecautionsAdverse Reactions---
Inspra (eplerenone) 25 mg and 50 mg Tablets--WarningsPrecautions----
Magnesium Sulfate in dextrose 5 percent injection, USP--WarningsPrecautions----
Magnesium Sulfate Injection, USP, 50 percent--WarningsPrecautions----
Magnesium Sulfate in Water for Injection, USP, in Flexible Plastic Container--WarningsPrecautions----
Neoral Soft Gelatin Capsules (cyclosporine capsules, USP) Neoral Oral Solution (cyclosporine oral solution, USP)--WarningsPrecautionsAdverse Reactions---
Sandimmune Injection (schizophrenics USP)Sandimmune Oral Solution (cyclosporine USP)Sandimmune Soft Gelatin Capsules (cyclosporine USP)--WarningsPrecautions----
Sandimmune Injection (cyclosporine USP)Sandimmune Oral Solution (cyclosporine USP)Sandimmune Soft Gelatin Capsules (cyclosporine USP)--WarningsPrecautions----
Tasmar (tolcapone) 100 mg Tablets--WarningsPrecautions----
Drug Name BW C W P AR PPI MG PCI
Exjade (deferasirox) Tablets---PrecautionsAdverse Reactions---
Megace ES (megestrol acetate) Oral Suspension, 625 mg/5 ml ---Precautions----
Metadate CD (methylphenidate HCl) Extended-Release Capsules 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg ---PrecautionsAdverse Reactions---
Prilosec (omeprazole) Delayed- Release Granules for Oral Suspension, 2.5 mg and 10 mgPrilosec (omeprazole) Delayed-Release Capsules, 10 mg, 20 mg, and 40 mg---Precautions----
Ritalin LA 10mg, 20mg, 30mg, and 40mg Capsules---Precautions----
Stivarga (regorafenib) Tablets---Precautions----
Viracept (nelfinavir mesylate) Oral Powder, 50 mg/gViracept (nelfinavir mesylate) Tablets, 250 mgViracept (nelfinavir mesylate) Tablets, 625 mg---Precautions----
Zyvox (linezolid) TabletsZyvox (linezolid) IV InjectionZyvox (linezolid) for Oral Suspension---Precautions----
Arimidex (anastrozole) Tablets, 1 mg----Adverse Reactions---
Concerta (methylphenidate HCL) 18 mg, 27 mg, 36 mg, and 54 mg Extended-Release Capsules ----Adverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Optimark and Optimark Pharmacy Bulk Package Injection----Adverse Reactions---
Stelara (ustekinumab)----Adverse Reactions---
Uroxatral (alfuzosin hydrochloride) extended-release tablets ----Adverse Reactions---
PegIntron (peginterferon alfa-2b)--------
Samsca (tolvaptan) 15 mg, and 30 mg Tablets--------
Rebetol (ribavirin USP) 200 mg Capsules and 40 mg/mL Oral Solution--------
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