Medication Guide App

Drug Safety Labeling Changes - July 2008

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July 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
Baraclude (entecavir) Tablets and Oral SolutionBoxed Warning-WarningsPrecautionsAdverse Reactions---
Exforge (amlodipine and valsartan) TabletsBoxed Warning-WarningsPrecautions-Patient Package Insert--
Strattera (atomoxetine hydrochloride) CapsulesBoxed Warning-WarningsPrecautionsAdverse Reactions---
Advair HFA (fluticasone propionate and salmeterol) Inhalation Aerosol for Oral Inhalation Only--Warnings-----
Avandia (rosiglitazone maleate) Tablets--WarningsPrecautionsAdverse Reactions---
Diovan HCT (valsartan and hydrochlorothiazide USP) Tablets--WarningsPrecautionsAdverse ReactionsPatient Package Insert--
FazaClo (clozapine, USP) Orally Disintegrating Tablets--Warnings-Adverse Reactions---
Januvia (sitagliptin) Tablets--WarningsPrecautions----
Lopressor (metoprolol tartrate) Tablets--Warnings-Adverse Reactions---
Lopressor (metoprolol tartrate) Injection, Solution--Warnings-Adverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Lopressor HCT (metoprolol tartrate USP and hydrochlorothiazide USP) Tablets--Warnings-Adverse Reactions---
Lovenox (enoxaparin sodium injection) for Subcutaneous and Intravenous Use--WarningsPrecautionsAdverse Reactions---
Mirena (levonorgestrel-releasing intrauterine system)--WarningsPrecautionsAdverse ReactionsPatient Package Insert--
Primaquine (primaquine phosphate tablets, USP)--Warnings-----
Cancidas (caspofungin acetate) for Injection (Intravenous Use Only)---PrecautionsAdverse Reactions---
Capastat Sulfate (capreomycin for injection, USP) for Intramuscular and Intravenous Infusion Only---PrecautionsAdverse Reactions---
Colazal (balsalazide disodium) Capsules---PrecautionsAdverse Reactions---
Coreg (carvedilol) Tablets---Precautions----
Duac Topical Gel (clindamycin, 1% - benzoyl peroxide, 5%)---PrecautionsAdverse Reactions---
Flovent HFA (fluticasone propionate) Inhalation Aerosol for Oral Inhalation Only---Precautions-Patient Package Insert--
Drug Name BW C W P AR PPI MG PCI
Fortamet (metformin hydrochloride) Extended-Release Tablets---Precautions----
Levoxyl (levothyroxine sodium) Tablets---Precautions----
Natacyn (natamycin ophthalmic suspension) 5%---PrecautionsAdverse Reactions---
Prandin (repaglinide) Tablets ---Precautions----
Starlix (nateglinide) Tablets---Precautions----
Symbicort (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol for Oral Inhalation Only---Precautions----
Synthroid (levothyroxine sodium tablets, USP)---Precautions----
Abraxane for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) [albumin-bound]----Adverse Reactions---
Imuran (azathioprine) 50 mg Tablets and 100 mg (as the sodium salt) for Intravenous Injection----Adverse Reactions---
Simcor (simvastatin/niacin extended-release) Tablet, Film Coated, Extended Release for Oral Use----Adverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Anaprox/Anaprox DS (naproxen sodium tablets)--------
Naprosyn (naproxen suspension)--------
Enbrel (etanercept) for Subcutaneous Injection--------
Vicoprofen (hydrocodone bitartrate/ibuprofen) Tablets--------
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