Drug Safety Labeling Changes - October 2011

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October 2011

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
Definity Vial for (Perflutren Lipid Microsphere) Injectable SuspensionBoxed Warning-WarningsPrecautionsAdverse Reactions---
Evamist (estradiol transdermal spray)Boxed Warning-WarningsPrecautions-Patient Package Insert--
Demerol (meperidine hydrochloride)-Contraindications-Precautions----
Premarin (conjugated estrogens tablets, USP)-ContraindicationsWarnings--Patient Package Insert--
Suprenza (phentermine hydrochloride) ODT-Contraindications------
Avelox (moxifloxacin hydrochloride) Tablets and IV--WarningsPrecautions----
Byetta (exenatide) injection--WarningsPrecautionsAdverse Reactions---
Clozaril (clozapine) Tablets--WarningsPrecautions----
Ciprofloxacin Tablets Ciprofloxacin IV for Inusion Vial Ciprofloxacin 0.2 % Solution in 5% Dextrose Ciprofloxacin Oral Suspension Cipro XR Tablets--Warnings-----
Factive (gemifloxacin mesylate) Tablets--Warnings-----
Drug Name BW C W P AR PPI MG PCI
Gallium Citrate Ga 67 Injection--Warnings-----
Sodium Lactate (M/6 sodium lactate) injections in viaflex plastic container--WarningsPrecautionsAdverse Reactions---
Levaquin (levofloxacin) Tablets--WarningsPrecautions----
Lithium Carbonate 150 mg, 300 mg, and 600 mg capsules--Warnings-Adverse Reactions---
Lithobid (lithium carbonate) Extended-Release tablets--Warnings-Adverse Reactions---
Nexavar (sorafenib)--WarningsPrecautionsAdverse Reactions---
Noroxin (norfloxacin) Tablets--Warnings-----
OxyContin (oxycodone hydrochloride) Controlled-Release Tablets--WarningsPrecautions----
Veramyst, (fluticasone furoate) Nasal Spray--WarningsPrecautionsAdverse Reactions---
Vumon (teniposide) Injection--Warnings-Adverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Accuretic (quinapril HCl/hydrochlorothiazide)---Precautions----
Azor (amlodipine and olmesartan medoxomil) Tablets---Precautions----
Ixempra kit (ixabepilone) for injection---Precautions----
Leukeran (chlorambucil) Tablet---Precautions----
Lotrel (amlodipine besylate and benazepril hydrochloride) Capsules---Precautions----
Macugen (pegaptanib sodium injection)---Precautions----
Norvasc (amlodipine besylate) Tablets---Precautions----
Prevacid (lansoprazole) Delayed-Release Capsules and Prevacid Solutab (lansoprazole) Delayed-Release Orally Disintegrating Tablets---Precautions----
Protonix (pantoprazole sodium) For Delayed Release Oral Suspension and Delayed Release Tablets---Precautions----
Tekturna (aliskiren) Tablets---Precautions----
Drug Name BW C W P AR PPI MG PCI
Prezista (darunavir) Tablets----Adverse ReactionsPatient Package Insert--
Reyataz (atazanavir sulfate)----Adverse Reactions---
Symbyax (olanzapine and fluoxetine HCl)----Adverse Reactions---
Humalog Mix 75/25 (75% insulin lispro protamine suspension/25% insulin lispro injection [rDNA origin]) Humalog Mix 50/50 (50% insulin lispro protamine suspension/50 insulin lispro injection [rDNA origin])-----Patient Package Insert--
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