Medication Guide App

Drug Safety Labeling Changes - November 2008

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November 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
Truvada (emtricitabine/tenofovir disoproxil fumarate) TabletsBoxed Warning-WarningsPrecautionsAdverse ReactionsPatient Package Insert--
Viread (tenofovir disoproxil fumarate) TabletsBoxed Warning-WarningsPrecautionsAdverse ReactionsPatient Package Insert--
Promethazine HCl and Codeine Phosphate Oral Solution-ContraindicationsWarningsPrecautions----
Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution-ContraindicationsWarningsPrecautions----
Sucraid (sacrosidase) Oral Solution-Contraindications---Patient Package Insert--
Aldactone (spironolactone tablets, USP)--Warnings-----
Avastin (bevacizumab) For Intravenous Use--WarningsPrecautionsAdverse Reactions---
Boniva (ibandronate sodium) Tablets--WarningsPrecautionsAdverse ReactionsPatient Package Insert--
Ethyol (amifostine) For Injection--WarningsPrecautionsAdverse Reactions---
Selzentry (maraviroc) Tablets--WarningsPrecautionsAdverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Triglide (fenofibrate) Tablets--WarningsPrecautions----
Combivent Inhalation Aerosol (ipratropium bromide and albuterol sulfate)---PrecautionsAdverse ReactionsPatient Package Insert--
Emend (aprepitant) Capsules---Precautions----
Neulasta (pegfilgrastim)---Precautions----
Qualaquin (quinine sulfate) Capsules, USP---Precautions----
VESIcare (solifenacin succinate) Tablets----Adverse Reactions---
Accutane (isotretinoin capsules)--------
Levemir (insulin detemir [rDNA origin] injection)-----Patient Package Insert--
Levemir (insulin detemir [rDNA origin] injection) FlexPen--------
MoviPrep (PEG-3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid) Oral solution-----Patient Package Insert--
Drug Name BW C W P AR PPI MG PCI
NovoLog (insulin aspart [rDNA origin] injection)-----Patient Package Insert--
NovoLog (insulin aspart [rDNA origin] Injection) FlexPen-----Patient Package Insert--
NovoLog Mix 70/30 (70% insulin aspart protamine suspension and 30% insulin aspart injection, [rDNA origin])-----Patient Package Insert--
NovoLog Mix 70/30 (70% insulin aspart protamine suspension and 30% insulin aspart injection, [rDNA origin]) FlexPen-----Patient Package Insert--
Pegasys (peginterferon alfa-2a)--------
Viracept (nelfinavir mesylate) Tablets and Oral Powder-----Patient Package Insert--
Vyvanse (lisdexamfetamine dimesylate) Capsules--------
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