Drug Safety Labeling Changes - May 2012

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May 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
Lotensin (benazepril)Boxed Warning-WarningsPrecautionsAdverse Reactions---
Divigel (estradiol gel)-ContraindicationsWarningsPrecautions----
Focalin (dexmethylphenidate hydrochloride)-Contraindications--Adverse Reactions---
Focalin XR (dexmethylphenidate hydrochloride) -Contraindications--Adverse Reactions---
2% Chlorhexidine Gluconate (CHG) Cloth--Warnings-----
Aciphex (rabeprazole sodium) Delayed-Release Tablets--WarningsPrecautions----
Actoplus Met (pioglitazone hydrochloride plus metformin hydrochloride) Tablets--WarningsPrecautionsAdverse Reactions---
Aredia (pamidronate disodium) for Injection--WarningsPrecautionsAdverse Reactions---
Avagard Surgical and Healthcare Personnel Hand Antiseptic (chlorhexidine gluconate 1% solution and ethyl alcohol 61% w/w) Lotion--Warnings-----
Biaxin Granules (clarithromycin for oral suspension, USP)--WarningsPrecautions----
Drug Name BW C W P AR PPI MG PCI
Biaxin Filmtabs (clarithromycin tablets, USP)--WarningsPrecautions----
Biaxin XL Filmtabs (clarithromycin extended release tablets) --WarningsPrecautions----
Catapres (clonidine hydrochloride) Tablets--WarningsPrecautions----
Catapres-TTS (clonidine) Transdermal Therapeutic System--WarningsPrecautions----
Chlorascrub Swabsticks--Warnings-----
Folotyn (pralatrexate injection)--WarningsPrecautionsAdverse Reactions---
Hibiclens (4% w/v chlorhexidine gluconate) solution--Warnings-----
Hibistat (0.5% chlorhexidine gluconate solution and 70% isopropyl alcohol w/w)--Warnings-----
Omeprazole/Sodium Bicarbonate/Magnesium Hydroxide Tablets--WarningsPrecautions----
Prevacid (lansoprazole) Delayed-Release CapsulesPrevacid (lansoprazole) Delayed-Release Orally Disintegrating Tablets--WarningsPrecautions----
Drug Name BW C W P AR PPI MG PCI
Protonix (pantoprazole sodium) For Delayed-Release Oral SuspensionProtonix (pantoprazole sodium) Delayed-Release Tablets--WarningsPrecautions----
Scrub-Stat 2% and Scrub-Stat 4% (chlorhexidine gluconate 2% and 4%) Solutions--Warnings-----
Ultravist (brand of iopromide) Injection--WarningsPrecautionsAdverse Reactions---
Ultravist (brand of iopromide) Injection Pharmacy Bulk Pack--WarningsPrecautionsAdverse Reactions---
Zarontin (ethosuximide) Capsules--WarningsPrecautionsAdverse Reactions---
Cubicin (daptomycin for injection) Intravenous---Precautions----
Effexor (venlafaxine HCl) TabletsEffexor XR (venlafaxine HCl) Extended-Release Capsules---Precautions----
Ella (ulipristal acetate)---Precautions----
Levemir (insulin detemir [rDNA origin]), Injection---PrecautionsAdverse Reactions---
Prolia (denosumab) ---Precautions----
Drug Name BW C W P AR PPI MG PCI
Venlafaxine HCl Extended-release Tablets---Precautions----
Amevive (alefacept)----Adverse Reactions---
DuoNeb (albuterol sulfate and ipratropium bromide) Inhalation Solution----Adverse Reactions---
Dysport (abobotulinumtoxinA)--------
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