Drug Safety Labeling Changes - November 2012

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November 2012

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
Luvox (fluvoxamine) Tablets-ContraindicationsWarnings-----
Luvox CR (fluvoxamine maleate) Extended-Release Capsules-ContraindicationsWarnings-----
Norpramin (desipramine hydrochloride) Tablets-ContraindicationsWarnings-----
Oleptro (trazodone hydrochloride) Extended-Release Tablets-ContraindicationsWarnings-----
Twynsta (telmisartan/amlodipine) Tablets-Contraindications-Precautions----
Victrelis (boceprevir) Capsules-ContraindicationsWarningsPrecautionsAdverse Reactions---
Acuvail (ketorolac tromethamine ophthalmic solution) 0.45%--WarningsPrecautions----
Cimzia (certolizumab pegol)--WarningsPrecautionsAdverse Reactions---
Cytotec (misoprostol) Tablets--WarningsPrecautions----
Effient (prasugrel hydrochloride) Tablets--WarningsPrecautions----
Drug Name BW C W P AR PPI MG PCI
Hepsera (adefovir dipivoxil) Tablets--WarningsPrecautions----
Norvir (ritonavir) Soft Gelatin Capsules, Tablets and Oral Solution--WarningsPrecautions----
PerioChip (chlorhexidine gluconate)--Warnings-----
Uloric (febuxostat) Tablets--Warnings-----
Zegerid (omeprazole/sodium bicarbonate) Powder for Oral SuspensionZegerid (omeprazole/sodium bicarbonate) Capsules--WarningsPrecautionsAdverse Reactions---
Zofran (ondansetron hydrochloride) Injection--WarningsPrecautions----
Arava (leflunomide) Tablets----Adverse Reactions---
Ditropan XL (oxybutynin chloride) Extended Release Tablets----Adverse Reactions---
Metvixia (methyl aminolevulinate HCl) Cream----Adverse Reactions---
NegGram (Nalidixic acid, USP) Caplet----Adverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Nplate (romiplostim)----Adverse Reactions---
Simponi (golimumab)----Adverse Reactions---
Zometa (zoledronic acid) Injection Single Dose Vial----Adverse Reactions---
Amitiza (lubiprostone) Capsule--------
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