Medication Guide App

Drug Safety Labeling Changes - April 2011

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April 2011

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
Aplenzin (bupropion hydrobromide) Extended-Release TabletsBoxed Warning-WarningsPrecautionsAdverse Reactions---
Advil PM Liqui-Gels (ibuprofen 200 mg/diphenhydramine hydrochloride 25 mg) capsules--Warnings-----
Aleve (naproxen sodium) tablets--Warnings-----
Cyanokit (hydroxocobalamin for Injection)--WarningsPrecautions----
Eligard (leuprolide acetate) injectable suspension--WarningsPrecautions----
Fuzeon (enfuvirtide) for Injection--WarningsPrecautions----
Gleevec (imatinib mesylate) Tablets--WarningsPrecautionsAdverse Reactions---
Janumet (sitagliptin/metformin hydrochloride) Tablets--WarningsPrecautionsAdverse Reactions---
Omnitrope (somatropin [rDNA origin] injection)--WarningsPrecautions----
Pregnyl (chorionic gonadotropin for Injection, USP)--Warnings-----
Drug Name BW C W P AR PPI MG PCI
Zemplar (Paricalcitol) Injection--WarningsPrecautionsAdverse Reactions---
Aclovate (alclometasone dipropionate) Cream---Precautions----
Aptivus (tipranavir) Capsules and Oral Solution---Precautions----
Diflucan (fluconazole) Tablets and I.V.---Precautions----
Exjade (deferasirox) Tablets for Oral Suspension---Precautions----
Kytril (granisetron hydrochloride) Intravenous Injection---Precautions----
Qualaquin (quinine sulfate USP) Capsules---Precautions----
Voltaren Ophthalmic (diclofenac sodium ophthalmic solution)---PrecautionsAdverse Reactions---
Arimidex (anastrozole) Tablets----Adverse Reactions---
Propecia (finastride) Tablet----Adverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Prozac Weekly (fluoxetine hydrochloride)----Adverse Reactions---
Relpax (eletriptan) Tablets----Adverse Reactions---
Symbyax (olanzapine and fluoxetine HCL) Capsules----Adverse Reactions---
MoviPrep (PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride,Sodium Ascorbate, and Ascorbic Acid for Oral Solution)--------
Rythmol SR Extended-Release Capsules-----Patient Package Insert--
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