Drug Safety Labeling Changes - February 2009

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February 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
Fludara (fludarabine phosphate), 50 milligrams, for intravenous injectionBoxed Warning-WarningsPrecautionsAdverse Reactions---
Novantrone (mitoxantrone HCl) InjectionBoxed Warning-Warnings-----
Heparin Sodium in 5% Dextrose Injection--WarningsPrecautionsAdverse Reactions---
Heparin Sodium in 0.9% Sodium Chloride Injection--WarningsPrecautionsAdverse Reactions---
Implanon (etonogestrel implant) 68 mg--Warnings-----
Prograf (tacrolimus) Capsules, 0.5 mg, 1 mg, and 5 mg--WarningsPrecautionsAdverse Reactions---
Prograf (tacrolimus) Injection, 5 mg/ml--WarningsPrecautionsAdverse Reactions---
Toprol XL (metoprolol succinate) 25 mg, 50 mg, 100 mg, and 200 mg Extended Release Tablets--Warnings-----
Tracleer (bosentan) 62.5 and 125 mg Tablets--Warnings-Adverse Reactions---
Zerit (stavudine) Capsules, 15 mg, 20 mg, 30 mg and 40 mg--Warnings-Adverse ReactionsPatient Package Insert--
Drug Name BW C W P AR PPI MG PCI
Zerit (stavudine) Powder for Oral Solution, 1mg/mL--Warnings-Adverse ReactionsPatient Package Insert--
Altace (ramipril) 1.25, 2.5, 5, and 10 Capsules---Precautions----
Altace (ramipril) 1.25, 2.5, 5 and 10 mg Tablets---Precautions----
Capozide (captopril/hydrochlorothiazide) 25/15, 50/15, 25/25, 50/25 mg Tablets---Precautions----
Casodex (bicalutamide) Tablets---PrecautionsAdverse Reactions---
Monopril (fosinopril sodium) 10, 20, and 40 mg Tablets---Precautions----
Monopril HCT (fosinopril/hydrochlorothiazide) 20/12.5mg and 10/12.5mg Tablets ---Precautions----
Noxafil (posaconazole) Oral Suspension, 40mg/mL---Precautions-Patient Package Insert--
Roxicodone (Oxycodone Hydrochloride) Tablets USP---Precautions----
Stalevo (levodopa/carbidopa/entacapone) Tablets 200/50/200 mg---Precautions----
Drug Name BW C W P AR PPI MG PCI
Symmetrel (amantadine hydrochloride) Syrup and Tablets---PrecautionsAdverse Reactions---
Tasmar (tolcapone) Tablets---Precautions----
Xenical (orlistat) Capsules, 120 mg---PrecautionsAdverse ReactionsPatient Package Insert--
Zantac 150/300 (ranitidine hydrochloride) Tablets---PrecautionsAdverse Reactions---
Zantac (ranitidine hydrochloride) Syrup, USP---PrecautionsAdverse Reactions---
Zantac 25/150 (ranitidine hydrochloride) EFFERdose Tablets and 150 (ranitidine hydrochloride effervescent) Granules---PrecautionsAdverse Reactions---
Zantac (ranitidine hydrochloride) Injection and Injection Bulk Pharmacy Pack---PrecautionsAdverse Reactions---
Zantac (ranitidine hydrochloride) Injection Premixed---PrecautionsAdverse Reactions---
Zithromax (azithromycin) IV---Precautions----
Arthrotec (diclofenac sodium and misoprostol) Tablets----Adverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Baraclude (entecavir) tablets and oral solution----Adverse Reactions---
Cataflam (diclofenac potassium immediate-release tablets)----Adverse Reactions---
Cedax (ceftibuten capsules) 400 mg----Adverse Reactions---
Cedax (ceftibuten for oral suspension) 18 mg/mL----Adverse Reactions---
Emend (aprepitant) capsules 40 mg, 80 mg, and 125 mg----Adverse ReactionsPatient Package Insert--
Emend (fosaprepitant dimeglumine) for Injection, 115 mg/mL----Adverse ReactionsPatient Package Insert--
Voltaren (diclofenac sodium enteric-coated tablets)----Adverse Reactions---
Voltaren-XR (diclofenac sodium extended-release tablets)----Adverse Reactions---
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