Drug Safety Labeling Changes - December 2011

Get news by email or subscribe to our news feeds.

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-ContraindicationsWarningsPrecautionsAdverse ReactionsPatient Package Insert--
Relenza (zanamivir) inhalation powder-Contraindications---Patient Package Insert--
Tyzeka (telbivudine) tablets and oral solution-ContraindicationsWarningsPrecautions----
Capoten (captopril) Tablets --WarningsPrecautions----
Danocrine brand of Danazol capsules--WarningsPrecautionsAdverse Reactions---
Desferal (deferoxamine mesylate) for injection--WarningsPrecautions----
Edarbi (azilsartan medoxomil) Tablets --WarningsPrecautions-Patient Package Insert--
Eloxatin (oxaliplatin)  for intravenous use--WarningsPrecautions----
Heparin Sodium Injection--WarningsPrecautions----
Isentress (raltegravir) scored, chewable tablets, film coated tablets--WarningsPrecautionsAdverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Keppra (levetiracetam) Tablets and oral solution--WarningsPrecautions----
Keppra (levetiracetam) Tablets and oral solution--WarningsPrecautions----
Onglyza (saxagliptin) tablets--WarningsPrecautionsAdverse Reactions---
Ovide (malathion) 0.5% lotion--Warnings-Adverse Reactions---
PegIntron (Peginterferon alfa-2b) Injection, Powder for Solution for Subcutaneous Use--WarningsPrecautions----
Plavix (clopidogrel bisulfate) tablets--WarningsPrecautions----
Remeron (mirtazapine) tablets and RemeronSolTab (mirtazapine) Orally Disintegrating tablets--Warnings-----
Remeron (mirtazapine) tablets and RemeronSolTab (mirtazapine) Orally Disintegrating tablets--Warnings-----
Zegerid (omeprazole/sodium bicarbonate) powder for oral suspension and capsules--WarningsPrecautions----
Avapro (irbesartan) Tablets---PrecautionsAdverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Diovan HCT (valsartan/hydrochloriothiazide) Tablets---Precautions-Patient Package Insert--
Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) tablets---Precautions----
Isoptin SR (verapamil hydrochloride) tablets---Precautions----
Nexterone (Amiodarone Hydrochloride) Premixed Injection for Intravenous Use---Precautions----
Solaraze (diclofenac sodium) gel 3%---Precautions----
Sustiva (efavirenz) capsules and tablets---Precautions----
Abraxane for Injectable Suspension (paclitaxel protein-bound particles for injectable----Adverse Reactions---
suspension) (albumin-bound), 100 milligram vial----Adverse Reactions---
Avastin (bevacizumab) Solution for intravenous infusion----Adverse Reactions---
Cleviprex (clevidipine) 0.5 mg/mL injectable emulsion----Adverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Elestat (epinastine hydrochloride ophthalmic solution) 0.05%----Adverse Reactions---
Femara (letrozole) tablets----Adverse Reactions---
Prezista (darunavir) suspension and tablets----Adverse Reactions---
Singulair (montelukast sodium) Tablets, Chewable Tablets, and Oral Granules----Adverse ReactionsPatient Package Insert--
Toviaz (fesoterodine fumarate) extended release tablets----Adverse Reactions---
Vancocin  (vancomycin hydrochloride) Capsules----Adverse Reactions---
Bystolic (nebivolol) Tablets--------
Hide
(web2)