Drug Safety Labeling Changes - May 2008

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May 2008

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 (perflutren lipid microsphere) Injectable SuspensionBoxed Warning-Warnings-Adverse Reactions---
Ceftriaxone for Injection and Dextrose Injection-ContraindicationsWarningsPrecautionsAdverse Reactions---
Accolate (zafirlukast) Tablet, Film Coated--Warnings-----
Caduet (amlodipine besylate/atorvastatin calcium) Tablets--WarningsPrecautions----
CellCept (mycophenolate mofetil capsules)--Warnings-Adverse Reactions---
CellCept (mycophenolate mofetil tablets)--Warnings-Adverse Reactions---
CellCept Oral Suspension (mycophenolate mofetil for oral suspension)--Warnings-Adverse Reactions---
CellCept Intravenous (mycophenolate mofetil hydrochloride for injection)--Warnings-Adverse Reactions---
Chantix (varenicline) Tablets--WarningsPrecautions----
Furadantin (nitrofurantoin) Oral Suspension--WarningsPrecautions----
Drug Name BW C W P AR PPI MG PCI
Herceptin (trastuzumab) Intravenous Infusion--WarningsPrecautionsAdverse Reactions---
Intron A (interferon alfa-2b, recombinant) For Injection--Warnings-----
Keflex (cephalexin) Capsules--WarningsPrecautions----
Keppra (levetiracetam) Injection for Intravenous Use--WarningsPrecautionsAdverse Reactions---
Levaquin (levofloxacin) Tablets and Oral Solution--WarningsPrecautions-Patient Package Insert--
Levaquin (levofloxacin) Injection, for Intravenous Use--WarningsPrecautions-Patient Package Insert--
Levaquin (levofloxacin in 5% dextrose) Injection, for Intravenous Use--WarningsPrecautions-Patient Package Insert--
Mycobutin (rifabutin capsules, USP)--WarningsPrecautions----
Myfortic (mycophenolic acid) Delayed-Release Tablets--Warnings-Adverse Reactions---
Primaxin I.M. (imipenem and cilastatin for injectable suspension)--WarningsPrecautions----
Drug Name BW C W P AR PPI MG PCI
Primaxin I.V. (imipenem and cilastatin) For Injection--WarningsPrecautions----
Abilify (aripiprazole) Tablets and Oral Solution---Precautions----
Abilify Discmelt (aripiprazole) Orally Disintegrating Tablets---Precautions----
Abilify (aripiprazole) Injection for Intramuscular Use Only---Precautions----
Aranesp (darbepoetin alfa) For Injection---PrecautionsAdverse Reactions---
Argatroban Injection---Precautions----
Biaxin Filmtab (clarithromycin tablets, USP)---Precautions----
Biaxin XL Filmtab (clarithromycin extended-release tablets)---Precautions----
Dexedrine (dextroamphetamine sulfate) Spansule Sustained-Release Capsules---Precautions----
E.E.S. (erythromycin ethylsuccinate)---Precautions----
Drug Name BW C W P AR PPI MG PCI
Ery-Ped (erythromycin ethylsuccinate, USP)---Precautions----
Inderal (propranolol hydrochloride) Tablets---Precautions----
Inspra (eplerenone) Tablets---Precautions----
Lotensin (benazepril hydrochloride) Tablets---PrecautionsAdverse Reactions---
Lotensin HCT (benazepril hydrochloride and hydrochlorothiazide, USP)---PrecautionsAdverse Reactions---
Malarone (atovaquone and proguanil hydrochloride) Tablets---Precautions----
Mepron (atovaquone) Suspension---PrecautionsAdverse Reactions---
PCE (erythromycin particles in tablets) Dispertabs Tablets---Precautions----
Sensipar (cinacalcet) Tablets---Precautions----
Tekturna (aliskiren) Tablets---Precautions-Patient Package Insert--
Drug Name BW C W P AR PPI MG PCI
Timentin (ticarcillin disodium and clavulanate potassium) Injection---Precautions----
Timentin (sterile ticarcillin disodium and clavulanate potassium) for Intravenous Administration---Precautions----
Vfend I.V. (voriconazole) for Injection---Precautions----
Vfend (voriconazole) Tablets---Precautions----
Vfend (voriconazole) for Oral Suspension---Precautions----
Effexor (venlafaxine hydrochloride) Tablets----Adverse Reactions---
Effexor XR (venlafaxine hydrochloride) Extended-Release Capsules----Adverse Reactions---
Emtriva (emtricitabine) Capsules and Oral Solution----Adverse Reactions---
Geodon (ziprasidone HCl) Capsules----Adverse Reactions---
Geodon (ziprasidone mesylate) for Injection For IM Use Only----Adverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Haldol (brand of haloperidol injection)For Immediate Release----Adverse Reactions---
Haldol Decanoate (haloperidol) For IM Injection Only----Adverse Reactions---
Invega (paliperidone) Extended-Release Tablets----Adverse Reactions---
Lariam (mefloquine hydrochloride) Tablets----Adverse Reactions---
Levitra (vardenafil hydrochloride) Tablets----Adverse Reactions---
Seroquel (quetiapine fumarate) Tablets----Adverse Reactions---
Seroquel XR (quetiapine fumarate) Extended-Release Tablets----Adverse Reactions---
Uroxatral (alfuzosin HCl extended-release tablets)----Adverse Reactions---
Viread (tenofovir disoproxil fumarate) Tablets----Adverse Reactions---
Actos (pioglitazone HCl) Tablets-----Patient Package Insert--
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