Drug Safety Labeling Changes - July 2010

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July 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
Duraclon (clonidine hydrochloride) injection--Warnings-----
Humatrope (somatropin [rDNA origin]) for injection--WarningsPrecautionsAdverse Reactions---
Imitrex (sumatriptan) injection, nasal spray and tablets--WarningsPrecautions----
Omeprazole 20 mg delayed-release tablets--Warnings-----
Percodan (oxycodone HCl and aspirin) tablets--Warnings-----
Relpax (eletriptan hydrobromide) tablets--Warnings-Adverse Reactions---
Vesicare (solifenacin succinate) tablet--WarningsPrecautionsAdverse Reactions---
Priftin (rifapentine) tablets---Precautions----
Creon (pancrelipase) delayed-release capsules----Adverse Reactions---
Sporanox (itraconazole) oral solution and capsules----Adverse ReactionsPatient Package Insert--
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