Medication Guide App

Drug Safety Labeling Changes - February 2011

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February 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
Avandaryl (rosiglitazone maleate/glimepiride) TabletsBoxed Warning-WarningsPrecautionsAdverse Reactions---
Proquin XR (ciprofloxacin) Extended-Release TabletsBoxed Warning-WarningsPrecautionsAdverse Reactions---
Flector Patch (diclofenac epolamine topical patch)-Contraindications------
Increlex (mecasermin [rDNA origin] injection-ContraindicationsWarningsPrecautionsAdverse Reactions---
Zebeta (bisoprolol fumarate) Tablets--Warnings-----
Adalat CC (nifedipine)  Extended Release Tablets---PrecautionsAdverse Reactions---
Betapace (sotalol hydrochloride) and Betapace AF (sotalol hydrochloride) Tablets---Precautions----
Cataflam (diclofenac potassium immediate-release tablets)---PrecautionsAdverse Reactions---
NebuPent (pentamidine isethionate)---Precautions----
Talwin Nx (pentazocine hydrochloride and naloxone Hydrochloride) Tablets---Precautions----
Drug Name BW C W P AR PPI MG PCI
Tazorac (tazarotene) Gel---PrecautionsAdverse Reactions---
Viracept (nelfinavir mesylate) Oral Powder and Tablets---Precautions-Patient Package Insert--
Voltaren (diclofenac sodium enteric-coated tablets) and Voltaren-XR (diclofenac sodium extended-release) tablets---PrecautionsAdverse Reactions---
Adenoscan (adenosine) Injection----Adverse Reactions---
Micronase (glyburide) tablets----Adverse Reactions---
Pegasys (ß (peginterferon alfa-2a)----Adverse Reactions---
Simcor (niacin extended release/simvastatin) Tablets----Adverse Reactions---
Zometa (zoledronic acid for injection)----Adverse Reactions---
Brovana (arformoterol) Inhalation Solution--------
Symbicort (budesonide and formoterol) Inhalation Aerosol--------
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