Drug Safety Labeling Changes - May 2011

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May 2011

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
Imuran (azathioprine) Tablets and InjectionBoxed Warning-Warnings-Adverse Reactions---
Imuran (azathioprine) Tablets and InjectionBoxed Warning-Warnings-Adverse Reactions---
Biaxin Filmtab (clarithromycin tablets, USP)Biaxin XL Filmtab (clarithromycin extended-release tablets)Biaxin Granules (clarithromycin for oral suspension, USP)-ContraindicationsWarnings-Adverse Reactions---
Biaxin Filmtab (clarithromycin tablets, USP)Biaxin XL Filmtab (clarithromycin extended-release tablets)Biaxin Granules (clarithromycin for oral suspension, USP)-ContraindicationsWarnings-Adverse Reactions---
Afinitor (everolimus) Tablets--WarningsPrecautions----
Afinitor (everolimus) Tablets--WarningsPrecautions----
Avandia (rosiglitazone maleate)Avandamet (rosiglitazone maleate/metformin hydrochloride)Avandaryl (rosiglitazone maleate/glimepiride) Tablets--WarningsPrecautions----
Avandia (rosiglitazone maleate)Avandamet (rosiglitazone maleate/metformin hydrochloride)Avandaryl (rosiglitazone maleate/glimepiride) Tablets--WarningsPrecautions----
Benicar HCT (olmesartan medoxomil/hydrochlorothiazide) Tablets--Warnings-----
Benicar HCT (olmesartan medoxomil/hydrochlorothiazide) Tablets--Warnings-----
Drug Name BW C W P AR PPI MG PCI
Genotropin (somatropin [rDNA origin] for Injection--WarningsPrecautionsAdverse Reactions---
Humalog (insulin lispro [rDNA origin]) Injection--WarningsPrecautions----
Humalog (insulin lispro [rDNA origin]) Injection--WarningsPrecautions----
Levatol (penbutolol sulfate) Tablets--WarningsPrecautions----
Levatol (penbutolol sulfate) Tablets--WarningsPrecautions----
Micardis HCT (telmisartan/hydrochlorothiazide) Tablets--WarningsPrecautions----
Norditropin Cartridges (somatropin [rDNA origin] injection)--WarningsPrecautionsAdverse Reactions---
Purinethol (mercaptopurine) Tablets--Warnings-----
Seroquel (quetiapine fumarate) Tablets--WarningsPrecautions----
Sutent (sunitinib malate) Capsules--WarningsPrecautionsAdverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Teveten HCT (eprosartan mesylate/hydrochlorothiazide) Tablets--WarningsPrecautions----
Uniretic (moexipril hydrochloride/hydrochlorothiazide)--Warnings-----
Uniretic (moexipril hydrochloride/hydrochlorothiazide)--Warnings-----
Zegerid (omeprazole/sodium bicarbonate) Capsules and Powder for Oral Suspension--WarningsPrecautionsAdverse Reactions---
Ziac (bisoprolol fumarate/hydrochlorothiazide) Tablets--Warnings-----
Ziac (bisoprolol fumarate/hydrochlorothiazide) Tablets--Warnings-----
Azor (amlodipine and olmesartan medoxomil) Tablets---PrecautionsAdverse Reactions---
Lexiva (fosamprenavir calcium) Tablets and Oral Suspension---Precautions----
Teveten (eprosartan mesylate) Tablets---Precautions----
Teveten (eprosartan mesylate) Tablets---Precautions----
Drug Name BW C W P AR PPI MG PCI
Valturna (aliskiren/valsartan) Tablets---Precautions----
Vibramycin (doxycycline monohydrate) Oral Suspension----Adverse Reactions---
Vibra-Tabs (doxycycline hyclate) ----Adverse Reactions---
Foradil Aerolizer (formoterol fumarate inhalation powder)--------
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