Drug Safety Labeling Changes - October 2009

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October 2009

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
Azulfidine (sulfasalazine) and Azulfidine EN  (sulfasalazine delayed release) tablets-ContraindicationsWarnings-Adverse Reactions---
Lotrel (amlodipine besylate/benazepril hydrochloride) capsules-Contraindications-Precautions----
CellCept (mycophenolate mofetil) capsules, tablets, intravenous injection and oral suspension--Warnings-Adverse Reactions---
Hepsera (adefovir dipivoxil) 10 mg tablets--WarningsPrecautionsAdverse ReactionsPatient Package Insert--
Invega (paliperidone) ER tablets--WarningsPrecautionsAdverse Reactions---
Ixempra kit (ixabepilone) for intravenous infusion--WarningsPrecautions----
Neoral (cyclosporine) Modified soft gelatin capsules and oral solution--Warnings-Adverse Reactions---
Pulmicort Respules (budesonide) inhalation suspension--Warnings-Adverse ReactionsPatient Package Insert--
Rapamune (sirolimus) oral solution and tablets--Warnings-Adverse Reactions---
Sandimmune (cyclosporine) injection, oral solution, and soft gelatin capsules--Warnings-Adverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Viread (tenofovir disoproxil fumarate) tablets--Warnings-Adverse Reactions---
Albenza (albendazole) 200 mg tablets---Precautions----
Flomax (tamsulosin hydrochloride) capsule---Precautions----
Kytril (granisetron hydrochloride) injection, tablets and oral solution---PrecautionsAdverse Reactions---
Miacalcin (calcitonin-salmon) nasal spray---PrecautionsAdverse Reactions---
Lialda (mesalamine) delayed-release tablet----Adverse Reactions---
Miacalcin (calcitonin-salmon) injection----Adverse Reactions---
Byetta (exenatide) injection--------
Chantix (varenicline) tablets--------
Visicol (sodium phosphate monobasic monohydrate and sodium phosphate dibasic anhydrous) tablets--------
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