Drug Safety Labeling Changes - July 2011

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July 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
Epogen/Procrit (epoetin alfa) and Aranesp (darbepoetin alfa)Boxed Warning-WarningsPrecautions----
Nitrostat (nitroglycerin, USP) Sublingual Tablets-Contraindications-Precautions-Patient Package Insert--
Bentyl (dicyclomine hydrochloride, USP) Capsules/Tablets, Oral Syrup, Injection--WarningsPrecautions----
Gilenya (fingolimod) capsules 0.5 mg--WarningsPrecautions----
Kenalog-10 (triamcinolone acetonide) Injection Kenalog-40 (triamcinolone acetonide) Injection--Warnings-Adverse Reactions---
Micardis (telmisartan) Tablets---Precautions----
Prograf (tacrolimus) Capsules, Injection--WarningsPrecautionsAdverse Reactions---
Seroquel (quetiapine fumarate) Tablets Seroquel (quetiapine fumarate) XR--WarningsPrecautionsAdverse Reactions---
Tev-Tropin (somatropin [rDNA origin]) for injection--WarningsPrecautionsAdverse Reactions---
Zegerid OTC (omeprazole 20mg and sodium bicarbonate 1100 mg) capsules--Warnings-----
Drug Name BW C W P AR PPI MG PCI
Cordran (flurandrenolide, USP) Lotion---PrecautionsAdverse Reactions---
 ---Precautions----
Mobic (meloxicam) Tablets, Oral Suspension---Precautions----
Spiriva HandiHaler (tiotropium bromide inhalation powder)---Precautions----
Wellbutrin XL (bupropion hydrochloride) Extended-Release Tablets Aplenzin (bupropion hydrobromide) Extended-Release Tablets---Precautions----
Wellbutrin (bupropion hydrochloride) Wellbutrin SR (bupropion hydrochloride) Sustained-Release Tablets ---Precautions----
Coreg (carvedilol) Tablets Coreg CR (carvedilol phosphate) Extended Release Capsules----Adverse Reactions---
Flovent HFA (fluticasone propionate) Inhalation Aerosol----Adverse Reactions---
Colcrys (colchicine) Tablets--------
Fentora (fentanyl buccal tablets)--------
Drug Name BW C W P AR PPI MG PCI
Tikosyn (dofetilide) Capsules--------
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