Drug Safety Labeling Changes - January 2014

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January 2014

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
Cozaar (losartan) 25 mg, 50 mg, and 100 mg Tablets Boxed Warning-WarningsPrecautions-Patient Package Insert--
Hyzaar (losartan/hydrochlorothiazide) 50/12.5 mg, 100/12.5 mg, and 100/25 mg TabletsBoxed Warning-WarningsPrecautions-Patient Package Insert--
Lidocaine Hydrochloride (4% and 8%) and Dextrose 5% Injection -ContraindicationsWarningsPrecautionsAdverse Reactions---
Victrelis (boceprevir), 200 mg capsules-Contraindications-Precautions----
Cerebyx (fosphenytoin)--WarningsPrecautions----
Doribax (doripenem) for Injection --WarningsPrecautions----
FeverAll (acetaminophen) 80 mg, 120 mg, 325 mg, and 650 mg Suppositories --Warnings-----
Multaq (dronedarone hydrochloride) 400 mg Tablets--WarningsPrecautions----
Revatio 20 mg Tablets Revatio 10 mg/12.5 mL for Injection Revatio 10 mg/mL Powder for Oral suspension--WarningsPrecautions-Patient Package Insert--
Topamax (topiramate) Tablets (25mg, 50mg, 100mg, and 200mg)Topamax (topiramate) Sprinkle Capsules (15mg, and 25mg)--WarningsPrecautions----
Drug Name BW C W P AR PPI MG PCI
Vidaza (azacitidine) for Injection--WarningsPrecautions----
Accuretic (quinapril/hydrochlorothiazide) 10/12.5 mg, 20/12.5 mg, and 20/25 mg Tablets ---PrecautionsAdverse Reactions---
Aldactazide (spironolctone/hydrochlorothiazide) 25/25 mg, and 50/50 mg Tablets---PrecautionsAdverse Reactions---
Dilantin - 125 (phenytoin) Oral Suspension Dilantin (phenytoin) Injection---PrecautionsAdverse Reactions---
Eliquis (apixaban) 2.5 and 5 mg Tablets ---Precautions----
Tegretol (carbamazepine) Chewable Tablets, Tegretol (carbamazepine) Oral Suspension Tegretol-XR (carbamazepine extended-release) Tablets ---Precautions----
Cordarone (amiodarone HCl) Tablets ----Adverse Reactions---
Propecia (finasteride) Tablet, 1 mg ----Adverse ReactionsPatient Package Insert--
Viramune (nevirapine) tablets and oral suspension----Adverse Reactions---
Viramune XR (nevirapine) extended-release tablets----Adverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Zyvox (linezolid) Oral Tablets, 400 mg and 600 mgZyvox (linezolid) IV Injection, 2 mg/mLZyvox (linezolid) for Oral Suspension, 100 mg/5mL----Adverse Reactions---
Letairis (ambrisentan) 5 mg and 10 mg Tablets --------
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