Drug Safety Labeling Changes - May 2010

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May 2010

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
PrandiMet (repaglinide/metformin HCl fixed-dose combination) tablet-ContraindicationsWarningsPrecautions----
Camptosar (irinotecan HCl) injection--WarningsPrecautionsAdverse Reactions---
Cervidil (dinoprostone) vaginal insert--Warnings-Adverse Reactions---
Droxia and Hydrea (hydroxyurea) capsules--WarningsPrecautions----
NovoLog Mix 70/30 (70% insulin aspart protamine suspension and 30% insulin aspart [rDNA origin]) injection--WarningsPrecautionsAdverse Reactions---
Tekturna HCT (aliskiren/hydrochlorothiazide) tablets--WarningsPrecautions----
Zyprexa (olanzapine) tablet, orally disintegrating tablet, and injection--WarningsPrecautionsAdverse Reactions---
Asacol (mesalamine) 400 mg and Asacol HD (mesalamine) 800 mg delayed-release tablets---Precautions----
Prevacid (lansoprazole) delayed-release capsules and orally disintegrating tablets---Precautions----
Topicort (desoximetasone) ointment---Precautions----
Drug Name BW C W P AR PPI MG PCI
Wellbutrin XL (bupropion HCl) extended-release tablets---Precautions----
MS Contin (morphine sulfate) controlled-release tablets----Adverse Reactions---
Zyprexa Relprevv (olanzapine) for extended release injectable suspension----Adverse Reactions---
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