Drug Safety Labeling Changes - June 2008

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June 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
Optison (Perflutren Protein -Type A Microspheres Injectable Suspension, USP)Boxed Warning-Warnings-----
Viramune (nevirapine) Tablets and Oral SuspensionBoxed WarningContraindicationsWarningsPrecautionsAdverse Reactions---
Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate) Tablets-ContraindicationsWarningsPrecautionsAdverse ReactionsPatient Package Insert--
Avodart (dutasteride) Soft Gelatin Capsules-ContraindicationsWarningsPrecautionsAdverse Reactions---
Kaletra (lopinavir and ritonavir) Tablet, Film Coated for Oral Use-Contraindications-PrecautionsAdverse ReactionsPatient Package Insert--
Kaletra (lopinavir and ritonavir) Solution for Oral Use-Contraindications-PrecautionsAdverse ReactionsPatient Package Insert--
Reclast (zoledronic acid) Injection-ContraindicationsWarningsPrecautionsAdverse ReactionsPatient Package Insert--
Zyvox (linezolid) Injection-Contraindications------
Zyvox (linezolid) Tablets-Contraindications------
Zyvox (linezolid) for Oral Suspension-Contraindications------
Drug Name BW C W P AR PPI MG PCI
Advil Allergy Sinus Caplets (ibuprofen, pseudoephedrine HCl, chlorpheniramine maleate)--Warnings-----
Advil Cold & Sinus (ibuprofen and pseudoephedrine HCl) Caplets--Warnings-----
Advil Cold & Sinus Liqui-Gels (ibuprofen and pseudoephedrine HCl) Capsules--Warnings-----
Advil Liqui-Gels (ibuprofen) Capsules--Warnings-----
Advil Migraine (ibuprofen) Capsules--Warnings-----
Advil PM (ibuprofen, diphenhydramine citrate) Caplets--Warnings-----
Advil PM Liqui-Gels (ibuprofen, diphenhydramine HCl) Capsules--Warnings-----
Advil (ibuprofen) Tablets--Warnings-----
Antara (fenofibrate) Capsules--Warnings-----
Celestone Soluspan (betamethasone sodium phosphate and betamethasone acetate Injectable Suspension, USP)--WarningsPrecautions----
Drug Name BW C W P AR PPI MG PCI
Children’s Advil Chewables (50 ibuprofen) Chewable Tablets--Warnings-----
Junior Strength Advil Chewables (100 mg ibuprofen) Chewable Tablets--Warnings-----
Children’s Advil (ibuprofen) Suspension--Warnings-----
Clozaril (clozapine) Tablets--Warnings-Adverse Reactions---
Cymbalta (duloxetine hydrochloride) Delayed-Release Capsules--WarningsPrecautionsAdverse Reactions---
Infants' Advil (ibuprofen) Concentrated Drops--Warnings-----
Junior Strength Advil (ibuprofen) Tablets--Warnings-----
Metvixia (methyl aminolevulinate) Cream, 16.8% For Topical Use Only--WarningsPrecautionsAdverse ReactionsPatient Package Insert--
Potassium Chloride Extended Release Tablets, USP--WarningsPrecautions----
Pulmicort Flexhaler (budesonide inhalation powder) For Oral Inhalation Only--WarningsPrecautions----
Drug Name BW C W P AR PPI MG PCI
Synercid I.V. (quinupristin and dalfopristin for injection)--WarningsPrecautions----
Vectibix (panitumumab) Injection For Intravenous Use--WarningsPrecautionsAdverse Reactions---
Amoxicillin/Clavulanate Potassium Tablets---Precautions----
Amoxil (amoxicillin capsules, tablets, chewable tablets, and powder for oral suspension)---PrecautionsAdverse Reactions---
Doryx (doxycycline hyclate) Delayed-Release Tablets---Precautions----
Ganirelix Acetate Injection---PrecautionsAdverse Reactions---
Levothyroxine Sodium Tablets, USP---Precautions----
Ortho Micronor (norethindrone) Tablets---Precautions----
Sarafem (fluoxetine hydrochloride) Capsules---Precautions----
Aciphex (rabeprazole sodium) Delayed Release Tablets----Adverse ReactionsPatient Package Insert--
Drug Name BW C W P AR PPI MG PCI
Baraclude (entecavir) Tablets and Oral Solution----Adverse ReactionsPatient Package Insert--
Gardasil [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant]----Adverse ReactionsPatient Package Insert--
Genotropin (somatropin [rDNA origin] for injection)----Adverse Reactions---
OxyContin (oxycodone HCl controlled-release) Tablets----Adverse Reactions---
Spiriva HandiHaler (tiotropium bromide inhalation powder)----Adverse ReactionsPatient Package Insert--
Vytorin (ezetimibe/simvastatin) Tablets----Adverse ReactionsPatient Package Insert--
Zetia (ezetimibe) Tablets----Adverse ReactionsPatient Package Insert--
Byetta (exenatide) Injection-----Patient Package Insert--
Forteo (teriparatide [rDNA origin]) Injection--------
PegIntron/REBETOL Combo Pack containing: PegIntron REDIPEN Single-dose Delivery System (peginterferon alfa-2b) and REBETOL (ribavirin, USP) Capsules--------
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