Drug Safety Labeling Changes - January 2009

Get news by email or subscribe to our news feeds.

January 2009

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
Avelox (moxifloxacin hydrochloride) Tablets, 400 mg--Warnings-Adverse Reactions---
Avelox (moxifloxacin hydrochloride in NaCl injection) I.V., 160 mg/mL--Warnings-Adverse Reactions---
Celexa (citalopram hydrobromide) solution--Warnings-----
Lexapro (escitalopram oxalate) tablets--Warnings-----
Lexapro (escitalopram oxalate) oral solution--Warnings-----
Cymbalta (duloxetine hydrochloride) Delayed-Release Capsules 20, 30 and 60 mg--Warnings-----
Effexor XR (venlafaxine HCl) Extended-Release Capsules and Effexor (venlafaxine HCl) Tablets--Warnings-----
Hycodan (hydrocodone and homatropine) Tablets--WarningsPrecautionsAdverse Reactions---
Nicardipine Hydrochloride Injection 25 mg/Vial, 2.5 mg/ml--WarningsPrecautions----
Paxil (paroxetine HCl) tablets--Warnings-----
Drug Name BW C W P AR PPI MG PCI
Paxil (paroxetine HCl) CR tablets--Warnings-----
Paxil (paroxetine) oral suspension--Warnings-----
Pexeva (paroxetine mesylate) tablets--Warnings-----
Pristiq (desvenlafaxine succinate) Extended-Release tablets--Warnings-----
Prozac (fluoxetine HCl) pulvules--Warnings-----
Prozac (fluoxetine HCl) oral solution--Warnings-----
Prozac Weekly (fluoxetine HCl) delayed-release capsules--Warnings-----
Tygacil (tigecycline)--WarningsPrecautionsAdverse Reactions---
Tyzeka (telbivudine) 600 mg tablets--Warnings-----
Venlafaxine hydrochloride extended release tablets--Warnings-----
Drug Name BW C W P AR PPI MG PCI
Zoloft (sertraline HCl) Tablets and Oral Concentrate--Warnings-----
ActoPlus Met (pioglitazone HCl plus metformin HCl tablets), 15 mg/500mg and 15 mg/850 mg---Precautions----
Duetact (pioglitazone HCl plus glimepiride fixed-dose combination tablets), 30 mg/2 mg and 30 mg/4 mg---Precautions----
Lotensin (benazepril hydrochloride) 2.5, 5, 10 and 20 mg---Precautions----
Lotensin HCT (benazepril/hydrochlorothiazide) 5/6.25, 10/12.5, 20/12.5 and 20/25mg Tablets---Precautions----
Nexium IV (esomeprazole sodium) for Injection---Precautions----
Nexium (esomeprazole magnesium) for Delayed-Release Capsules and Delayed-Release Oral Suspensions---Precautions----
Plasma-Lyte 148 and 5% Dextrose Injection in Plastic Container Plasma-Lyte 148 Injection in Plastic Container (includes Plasma-Lyte A Injection pH 7.4)---Precautions----
Augmentin ES-600 (amoxicillin/clavulanate potassium) 600 mg/5 mL Powder for Oral Suspension----Adverse Reactions---
Isentress (raltegravir potassium) 400 mg tablets----Adverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Rapamune (sirolimus) Oral Solution----Adverse Reactions---
Rapamune (sirolimus) Tablets----Adverse Reactions---
Singulair (montelukast sodium) tablets, chewable tables and oral granules----Adverse Reactions---
Crestor (rosuvastatin calcium) Tablets--------
Vytorin (ezetimibe/simvastatin) Tablets--------
Hide
(web1)