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