Drug Safety Labeling Changes - June 2011

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June 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
Simcor (niacin extended-release/simvastatin) tablets-ContraindicationsWarningsPrecautionsAdverse Reactions---
Sumavel DosePro (sumatriptan) injection for subcutaneous use-Contraindications------
Avalide (irbesartan/hydrochlorothiazide) tablets--WarningsPrecautions----
Corzide (nadolol and bendroflumethiazide) tablets--Warnings-----
Diflucan (fluconazole) tablets, I.V, and oral suspension--Warnings-----
Ditropan XL (oxybutynin chloride) tablets--WarningsPrecautions----
Jalyn (dutasteride and tamsulosin) capsules--WarningsPrecautions----
Nexium (esomeprazole magnesium) for delayed-release oral suspension,  delayed-release capsules and (esomeprazole sodium) for injection--WarningsPrecautionsAdverse ReactionsPatient Package Insert--
Photofrin (porfimer sodium) for injection--WarningsPrecautionsAdverse Reactions---
Prilosec (omeprazole magnesium) for delayed-release oral suspension and delayed-release capsules--WarningsPrecautions-Patient Package Insert--
Drug Name BW C W P AR PPI MG PCI
Proscar (finasteride) tablets--WarningsPrecautions----
Prozac Pulvules (fluoxetine hydrochloride) capsules for oral use and Prozac Weekly (fluoxetine hydrochloride) delayed-release capsules--WarningsPrecautionsAdverse Reactions---
Renagel (sevelamer hydrochloride) tablets and Renvela (sevelamer carbonate) powder for oral suspension and tablets--WarningsPrecautions----
Torisel (temsirolimus) injection--WarningsPrecautions----
Venofer (iron sucrose) injection--WarningsPrecautions----
Atacand (candesartan cilexetil) tablets and Atacand HCT (candesartan/cilexetil hydrochlorothiazide) tablets---Precautions----
Benicar (olmesartan medoxomil) tablets---Precautions----
Dilacor XR (diltiazem hydrochloride) extended release capsules---Precautions----
Lotrel (amlodipine besylate and benazepril hydrochloride) tablets---Precautions----
Twynsta (telmisartan/amlodipine) tablets  ---Precautions----
Drug Name BW C W P AR PPI MG PCI
Busulfex (busulfan) injection----Adverse Reactions---
Lupron Depot (leuprolide acetate) suspension----Adverse Reactions---
Mycamine (micafungin sodium) for injection----Adverse Reactions---
Neulasta (pegfigrastim) injection----Adverse Reactions---
Temodar (temozolomide) for Injection; vial and capsules----Adverse Reactions---
Omeprazole delayed-release tablets [OTC generic]--------
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