Drug Safety Labeling Changes - June 2010

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June 2010

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
Novantrone (mitoxantrone HCl) injectionBoxed WarningContraindications------
Symbicort Inhalation Aerosol (budesonide and formoterol)Boxed Warning-WarningsPrecautionsAdverse Reactions---
Ceftriaxone for Injection and Dextrose Injection in the Duplex Container-ContraindicationsWarnings-Adverse Reactions---
Solu-Medrol (methylprednisolone sodium succinate) for injection-ContraindicationsWarningsPrecautions----
Hycamtin (topotecan hydrochloride) capsules--WarningsPrecautionsAdverse Reactions---
Ovidrel (choriogonadotropin alfa injection) prefilled syringe--Warnings-Adverse Reactions---
Rybix ODT (tramadol hydrochloride) orally disintegrating tablet--Warnings-----
Clinoril (sulindac) tablets---Precautions----
Cosopt (dorzolamide hydrochloride and timolol maleate) ophthalmic solution---PrecautionsAdverse Reactions---
Dilacor XR (diltiazem HCl) extended release capsules---Precautions----
Drug Name BW C W P AR PPI MG PCI
Trusopt (dorzolamide hydrochloride ophthalmic solution)---Precautions----
Zylet (loteprednol etabonate and tobramycin) ophthalmic suspension---Precautions----
Acanya (clindamycin phosphate and benzoyl peroxide) gel----Adverse Reactions---
Dexilant (dexlansoprazole) delayed release capsules----Adverse Reactions---
Peganone (ethotoin) tablets--------
Qualaquin (quinine sulfate USP) capsule--------
Tranxene T-Tab (clorazepate dipotassium) tablets--------
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