Drug Safety Labeling Changes - October 2010

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October 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
Letairis (ambrisentan) tabletsBoxed WarningContraindicationsWarningsPrecautionsAdverse Reactions---
Invirase (saquinavir mesylate) tablets-ContraindicationsWarningsPrecautions----
Aldara (imiquimod) cream--WarningsPrecautions----
Depo-Provera Contraceptive injection (medroxyprogesterone acetate) injectable suspension--WarningsPrecautions----
Enablex (darifenacin) extended-release tablets--WarningsPrecautionsAdverse ReactionsPatient Package Insert--
Fragmin (dalteparin sodium) injection--WarningsPrecautions----
Gris-PEG (griseofulvin ultramicrosized) tablets--Warnings-Adverse Reactions---
Motrin Junior Strength chewable tablets, 100 mg--Warnings-----
Lamictal (lamotrigine) tablets, chewable dispersible tablets, Lamictal ODT (lamotrigine) orally disintegrating tablets, and Lamictal XR (lamotrigine) extended-release tablets--WarningsPrecautions----
Lasix (furosemide) tablets--WarningsPrecautionsAdverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Myfortic (mycophenolic acid) delayed-release tablet--WarningsPrecautions----
Nuvigil (armodafinil) tablets--Warnings-----
Precedex (dexmedetomidine hydrochloride) injection--WarningsPrecautionsAdverse Reactions---
Provigil (modafinil) tablets--Warnings-----
Rebetol (ribavirin) capsules and oral solution--WarningsPrecautions----
Rythmol SR (propafenone hydrochloride) extended-release capsules--WarningsPrecautionsAdverse Reactions---
Combivir (lamivudine/zidovudine) tablets---Precautions----
Cyanokit (hydroxocobalamin) intravenous use---Precautions----
Eligard (leuprolide acetate) for injectable suspension---Precautions----
Finacea (azelaic acid) gel---Precautions----
Drug Name BW C W P AR PPI MG PCI
Paxil (paroxetine HCl) tablets, oral solution and Paxil CR tablets---PrecautionsAdverse Reactions---
Stalevo (levodopa/carbidopa/entacapone) tablets---Precautions----
Cancidas (caspofungin acetate) for Injection----Adverse Reactions---
Lupron Depot and Lupron Depot 3 month (leuprolide acetate) for depot suspension----Adverse Reactions---
Proscar (finasteride) tablets----Adverse ReactionsPatient Package Insert--
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