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Drug Safety Labeling Changes - February 2015

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February 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
Osphena (ospemifene) Oral Tablets-Contraindications--Adverse Reactions---
Suprane (desflurane, USP) Volatile Liquid for Inhalation-ContraindicationsWarningsPrecautionsAdverse Reactions---
Apidra (insulin glulisine [rDNA origin]) injection --WarningsPrecautions----
Byetta (exenatide) injection --WarningsPrecautions----
Dianeal Peritoneal Dialysis Solution in Plastic Container, Low Calcium Peritoneal Dialysis Solution in ULTRABAG Plastic Container, and Dianeal PD-2 Peritoneal Dialysis Solution in ULTRABAG Plastic Container--Warnings-----
Ditropan XL (oxybutynin chloride) Extended Release Tablets--WarningsPrecautions----
Epivir (lamivudine) Tablets and Oral Solution--WarningsPrecautions----
Exelon (rivastigmine tartrate) Capsule and Oral Solution--WarningsPrecautionsAdverse Reactions---
Exelon Patch (rivastigmine) transdermal system--WarningsPrecautionsAdverse Reactions---
Firmagon (degarelix for injection) Lyophilized Powder for Injection--WarningsPrecautions----
Drug Name BW C W P AR PPI MG PCI
Gablofen (baclofen) Injection--WarningsPrecautions----
Humalog (insulin lispro [rDNA origin]) injection--WarningsPrecautions----
Humalog Mix 75/25 (75% insulin lispro protamine suspension /25% insulin lispro [rDNA origin]) injection--WarningsPrecautions----
Humalog Mix 50/50 (50% insulin lispro protamine suspension /50% insulin lispro [rDNA origin]) injection--WarningsPrecautions----
Humulin 70/30 (70% human insulin isophane suspension/30% insulin human injection, rDNA origin)--WarningsPrecautions----
Humulin N NPH (human insulin isophane suspension [rNDA origin])--WarningsPrecautions----
Humulin R (insulin human injection, USP [rDNA origin])--WarningsPrecautions----
Lantus (insulin glargine [rDNA origin]) injection--WarningsPrecautions----
Levemir (insulin detemir [rDNA origin]) injection --WarningsPrecautions----
Minipress (prazosin hydrochloride) Capsules--Warnings-----
Drug Name BW C W P AR PPI MG PCI
Minocin (minocycline hydrochloride) Oral Suspension--Warnings-----
Neupro Patch (rotigotine) Transdermal System--WarningsPrecautionsAdverse Reactions---
NovoLog (insulin aspart [rDNA origin]) injection --WarningsPrecautions----
NovoLog Mix 50/50 (50% insulin aspart protamine suspension and 50% insulin aspart [rDNA origin]) injection--WarningsPrecautions----
NovoLog Mix 70/30 (70% insulin aspart protamine suspension and 30% insulin aspart [rDNA origin]) injection--WarningsPrecautions----
Novolin N (NPH, human insulin isophane suspension [rDNA origin]) injection --WarningsPrecautions----
Razadyne (galantamine HBr) Tablets, Oral Solution--WarningsPrecautions----
Razadyne ER (galantamine HBr) Extended-Release Capsules--WarningsPrecautions----
Symlin (pramlintide acetate) injection--WarningsPrecautions----
VFEND (voriconazole) Tablets, for Oral Suspension, and for Injection--WarningsPrecautions----
Drug Name BW C W P AR PPI MG PCI
Victoza (liraglutide [rDNA origin]) injection--WarningsPrecautions----
Zoladex (goserelin acetate) Implant--WarningsPrecautions----
Atacand (candesartan cilexetil) Tablets---Precautions----
Atacand HCT (candesartan cilexetil/hydrochlorothiazide) Tablets---Precautions----
Binosto (alendronate sodium) Effervescent Tablets for Oral Solution---Precautions----
Feldene (piroxicam) Capsules---PrecautionsAdverse Reactions---
Ferriprox (deferiprone) Tablets---Precautions----
Isentress (raltegravir) for Oral Suspension, Chewable Tablets, and Film-coated Tablets---Precautions----
Trental (pentoxifylline) 400 mg Extended-Release Tablets---Precautions----
Caduet (atorvastatin calcium/amlodipine besylate) Tablets----Adverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Casodex (bicalutamide) Tablets----Adverse Reactions---
CISplatin Injection, Sterile Aqueous Injection----Adverse Reactions---
Kynamro (mipomersen) Injection----Adverse Reactions---
Miacalcin (calcitonin-salmon) Injection----Adverse Reactions---
Propylthiouracil Tablets----Adverse Reactions---
Torisel (temsirolimus) Injection----Adverse Reactions---
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