Drug Safety Labeling Changes - February 2013

Get news by email or subscribe to our news feeds.

February 2013

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
Aceon (perindopril erbumine) Tablets-Contraindications-Precautions----
Ellence (epirubicin hydrochloride) for Injection-ContraindicationsWarningsPrecautionsAdverse Reactions---
Prinivil (lisinopril) Tablets-Contraindications-Precautions----
Prinzide (lisinopril hydrochlorothiazide) Tablets-Contraindications-Precautions----
Rythmol SR (propafenone HCl) Extended-Release Capsules-ContraindicationsWarningsPrecautions----
Aromasin (exemestane) Tablets--WarningsPrecautionsAdverse Reactions---
FML (fluorometholone) Ophthalmic Suspension and Ointment--Warnings-----
FML Forte (fluorometholone) Ophthalmic Suspension--Warnings-----
Intelence (etravirine) Tablets--WarningsPrecautionsAdverse ReactionsPatient Package Insert--
Kapvay (clonidine hydrochloride) Extended-Release Tablets--WarningsPrecautionsAdverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Lidocaine Hydrochloride and 5% Dextrose Injection--Warnings-Adverse Reactions---
Niaspan (niacin extended release) Tablet--WarningsPrecautionsAdverse Reactions---
Prezista (darunavir) Oral Suspension and Tablet--WarningsPrecautionsAdverse Reactions---
Simcor (niacin ER/simvastatin) Tablets--WarningsPrecautionsAdverse Reactions---
Tricor (fenofibrate) Tablets--WarningsPrecautions----
Victrelis (boceprevir) Capsules--WarningsPrecautions----
Zithromax (azithromycin) for Oral Suspension, Tablet, Single Dose Packet, and for Injection (IV infusion)--Warnings-----
Zmax (azithromycin extended release) for Oral Suspension--Warnings-----
Zortress (everolimus) Tablets--WarningsPrecautions----
Dextrose 5% in Lactated Ringer’s Injection---Precautions----
Drug Name BW C W P AR PPI MG PCI
Lexiva (fosamprenavir calcium) Tablets and Oral Suspension---Precautions----
Rifadin (rifampin) capsules and Rifadin IV (rifampin) for Injection---Precautions----
Rifater (rifampin, isoniazid, and pyrazinamide) Tablets---Precautions----
Eligard (leuprolide acetate) Injection----Adverse Reactions---
Orfadin (nitisinone) Capsules----Adverse Reactions---
Trileptal (oxcarbazepine) Tablets and Oral Suspension----Adverse Reactions---
Vimpat (lacosamide) Tablets, Injection, and Oral Solution----Adverse Reactions---
Zioptan (tafluprost) Ophthalmic Solution----Adverse Reactions---
Zoloft (sertraline hydrochloride) Tablets and Oral Concentrate----Adverse Reactions---
Hide
(web2)