Drug Safety Labeling Changes - December 2011
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December 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 |
| Norvir (ritonavir) Soft Gel capsules, tablets, and oral solution | - |  | | | | | - | - |
| Relenza (zanamivir) inhalation powder | - | | - | - | - | | - | - |
| Tyzeka (telbivudine) tablets and oral solution | - | | | | - | - | - | - |
| Capoten (captopril) Tablets | - | - | | | - | - | - | - |
| Danocrine brand of Danazol capsules | - | - | | | | - | - | - |
| Desferal (deferoxamine mesylate) for injection | - | - | | | - | - | - | - |
| Edarbi (azilsartan medoxomil) Tablets | - | - | | | - | | - | - |
| Eloxatin (oxaliplatin) for intravenous use | - | - | | | - | - | - | - |
| Heparin Sodium Injection | - | - | | | - | - | - | - |
| Isentress (raltegravir) scored, chewable tablets, film coated tablets | - | - | | | | - | - | - |
| Drug Name |
BW |
C |
W |
P |
AR |
PPI |
MG |
PCI |
| Keppra (levetiracetam) Tablets and oral solution | - | - | | | - | - | - | - |
| Keppra (levetiracetam) Tablets and oral solution | - | - | | | - | - | - | - |
| Onglyza (saxagliptin) tablets | - | - | | | | - | - | - |
| Ovide (malathion) 0.5% lotion | - | - | | - | | - | - | - |
| PegIntron (Peginterferon alfa-2b) Injection, Powder for Solution for Subcutaneous Use | - | - | | | - | - | - | - |
| Plavix (clopidogrel bisulfate) tablets | - | - | | | - | - | - | - |
| Plavix (clopidogrel bisulfate) tablets | - | - | | | - | - | - | - |
| Remeron (mirtazapine) tablets and RemeronSolTab (mirtazapine) Orally Disintegrating tablets | - | - | | - | - | - | - | - |
| Remeron (mirtazapine) tablets and RemeronSolTab (mirtazapine) Orally Disintegrating tablets | - | - | | - | - | - | - | - |
| Zegerid (omeprazole/sodium bicarbonate) powder for oral suspension and capsules | - | - | | | - | - | - | - |
| Drug Name |
BW |
C |
W |
P |
AR |
PPI |
MG |
PCI |
| Avapro (irbesartan) Tablets | - | - | - | | | - | - | - |
| Diovan HCT (valsartan/hydrochloriothiazide) Tablets | - | - | - | | - | | - | - |
| Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) tablets | - | - | - | | - | - | - | - |
| Isoptin SR (verapamil hydrochloride) tablets | - | - | - | | - | - | - | - |
| Nexterone (Amiodarone Hydrochloride) Premixed Injection for Intravenous Use | - | - | - | | - | - | - | - |
| Solaraze (diclofenac sodium) gel 3% | - | - | - | | - | - | - | - |
| Sustiva (efavirenz) capsules and tablets | - | - | - | | - | - | - | - |
| Abraxane for Injectable Suspension (paclitaxel protein-bound particles for injectable | - | - | - | - | | - | - | - |
| suspension) (albumin-bound), 100 milligram vial | - | - | - | - | | - | - | - |
| Avastin (bevacizumab) Solution for intravenous infusion | - | - | - | - | | - | - | - |
| Drug Name |
BW |
C |
W |
P |
AR |
PPI |
MG |
PCI |
| Cleviprex (clevidipine) 0.5 mg/mL injectable emulsion | - | - | - | - | | - | - | - |
| Elestat (epinastine hydrochloride ophthalmic solution) 0.05% | - | - | - | - | | - | - | - |
| Femara (letrozole) tablets | - | - | - | - | | - | - | - |
| Prezista (darunavir) suspension and tablets | - | - | - | - | | - | - | - |
| Singulair (montelukast sodium) Tablets, Chewable Tablets, and Oral Granules | - | - | - | - | | | - | - |
| Singulair (montelukast sodium) Tablets, Chewable Tablets, and Oral Granules | - | - | - | - | | | - | - |
| Toviaz (fesoterodine fumarate) extended release tablets | - | - | - | - | | - | - | - |
| Vancocin (vancomycin hydrochloride) Capsules | - | - | - | - | | - | - | - |
| Bystolic (nebivolol) Tablets | - | - | - | - | - | - | - | - |
