Drug Safety Labeling Changes - March 2008

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March 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
Aranesp (darbepoetin alfa) for InjectionBoxed Warning-Warnings-----
Epogen (epoetin alfa) for InjectionBoxed Warning-Warnings-----
Avodart (dutasteride) Soft Gelatin Capsules-Contraindications--Adverse ReactionsPatient Package Insert--
Reyataz (atazanavir sulfate) Capsules-ContraindicationsWarningsPrecautionsAdverse ReactionsPatient Package Insert--
Tussionex Pennkinetic (hydrocodone polistirex and chlorpheniramine polistirex) Extended-Release Suspension-ContraindicationsWarningsPrecautionsAdverse Reactions---
Vfend I.V. (voriconazole) for Injection-Contraindications-Precautions-Patient Package Insert--
Vfend Tablets (voriconazole)-Contraindications-Precautions-Patient Package Insert--
Vfend (voriconazole) for Oral Suspension-Contraindications-Precautions-Patient Package Insert--
Aczone (dapsone) Gel, 5%--WarningsPrecautions-Patient Package Insert--
Advair HFA 45/21 (fluticasone propionate 45 mcg and salmeterol 21 mcg*) Inhalation Aerosol--WarningsPrecautions----
Drug Name BW C W P AR PPI MG PCI
Advair HFA 115/21 (fluticasone propionate 115 mcg and salmeterol 21 mcg*) Inhalation Aerosol--WarningsPrecautions----
Advair HFA 230/21 (fluticasone propionate 230 mcg and salmeterol 21 mcg*) Inhalation Aerosol--WarningsPrecautions----
Amoxil (amoxicillin capsules, tablets, chewable tablets, and powder for oral suspension)--WarningsPrecautions----
Augmentin (amoxicillin/clavulanate potassium) Powder for Oral Suspension and Chewable Tablets--WarningsPrecautions----
Augmentin (amoxicillin/clavulanate potassium) Tablets--WarningsPrecautions----
Depakote ER (divalproex sodium) Extended Release Tablets--WarningsPrecautions----
Depakote (divalproex sodium) Sprinkle Capsules--WarningsPrecautions----
Invanz (ertapenem for injection)--WarningsPrecautions----
Merrem I.V. (meropenem for injection) for Intravenous Use Only--WarningsPrecautionsAdverse Reactions---
Monurol (fosfomycin tromethamine) Sachet--WarningsPrecautions----
Drug Name BW C W P AR PPI MG PCI
NovoLog (insulin aspart [rDNA origin] injection) Solution for Subcutaneous Use--WarningsPrecautionsAdverse ReactionsPatient Package Insert--
Penicillin G Potassium Injection, USP--WarningsPrecautions----
Premarin Intravenous (conjugated estrogens, USP) for Injection--WarningsPrecautionsAdverse ReactionsPatient Package Insert--
Premarin (conjugated estrogens tablets, USP)--WarningsPrecautionsAdverse ReactionsPatient Package Insert--
Premarin (conjugated estrogens) Vaginal Cream in a nonliquefying base--WarningsPrecautionsAdverse ReactionsPatient Package Insert--
Prempro (conjugated estrogens/medroxyprogesterone acetate tablets)--WarningsPrecautionsAdverse Reactions---
Premphase (conjugated estrogens/medroxyprogesterone acetate tablets)--WarningsPrecautionsAdverse Reactions---
Prezista (darunavir) Tablets--WarningsPrecautionsAdverse ReactionsPatient Package Insert--
Primaxin I.M. (imipenem and cilastatin for injectable suspension)--WarningsPrecautions----
Primaxin I.V. (imipenem and cilastatin for injection)--WarningsPrecautions----
Drug Name BW C W P AR PPI MG PCI
Sandostatin LAR Depot (octreotide acetate for injectable suspension)--WarningsPrecautionsAdverse Reactions---
Serevent Diskus (salmeterol xinafoate inhalation powder)--WarningsPrecautions----
Zevalin (ibritumomab tiuxetan) Injection for Intravenous Use--WarningsPrecautionsAdverse Reactions---
Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate (butalbital, acetaminophen, caffeine, and codeine Phosphate) Capsules---Precautions----
Flolan (epoprostenol sodium) for Injection---Precautions----
Pexeva (paroxetine mesylate) Tablets---Precautions----
Ponstel (mefenamic acid capsules, USP)---Precautions----
Prozac (fluoxetine capsules, USP)---Precautions----
Septra I.V. Infusion (trimethoprim and sulfamethoxazole)---Precautions----
Septra Tablets (trimethoprim and sulfamethoxazole tablets)---Precautions----
Drug Name BW C W P AR PPI MG PCI
Septra DS Tablets (trimethoprim and sulfamethoxazole double-strength tablets)---Precautions----
Septra Suspension (trimethoprim and sulfamethoxazole suspension)---Precautions----
Septra Grape Suspension (trimethoprim and sulfamethoxazole grape suspension)---Precautions----
Symbyax (olanzapine and fluoxetine HCl capsules)---Precautions----
Tigan (trimethobenzamide hydrochloride) Capsules---Precautions----
Urex (methenamine hippurate) Tablets---Precautions----
Zometa (zoledronic acid) Injection Concentrate for Intravenous Infusion---Precautions----
Abilify (aripiprazole) Tablets and Oral Solution----Adverse Reactions---
Abilify Discmelt (aripiprazole) Orally Disintegrating Tablets----Adverse Reactions---
Abilify (aripiprazole) Injection for Intramuscular Use Only----Adverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Avastin (bevacizumab) for Intravenous Use----Adverse Reactions---
Azmacort (triamcinolone acetonide) Inhalation Aerosol----Adverse Reactions---
Levitra (vardenafil HCl) Tablets----Adverse Reactions---
PegIntron and Rebetol (peginterferon alfa-2b and ribavirin)----Adverse Reactions---
Moban (molindone hydrochloride tablets, USP)----Adverse Reactions---
Ventavis (iloprost) Inhalation Solution----Adverse ReactionsPatient Package Insert--
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