May 2012 Safety Labeling Changes

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The MedWatch May 2012 Safety Labeling Changes posting includes 41 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT.

The “Summary Page” provides a listing of drug names and safety labeling sections revised:

 http://www.fda.gov/Safety/MedWatch/SafetyInformation/Safety-RelatedDrugLabelingChanges/ucm306941.htm

The following drugs had modifications to the BOXED WARNINGS, CONTRAINDICATIONS and WARNINGS sections:

Lotensin (benazepril)
Divigel (estradiol gel)
Focalin (dexmethylphenidate hydrochloride)
Focalin XR (dexmethylphenidate hydrochloride)
Gilenya (Fingolimod)
2% Chlorhexidine Gluconate (CHG)    
Aciphex (rabeprazole sodium)
Actoplus Met (pioglitazone hydrochloride plus metformin hydrochloride)
Aredia (pamidronate disodium)
Avagard Surgical and Healthcare Personnel Hand Antiseptic (chlorhexidine gluconate 1% solution and ethyl alcohol 61% w/w)
Biaxin Filmtabs (clarithromycin tablets, USP)
Biaxin Granules (clarithromycin for oral suspension, USP)
Biaxin XL Filmtabs (clarithromycin extended release tablets)
Catapres (clonidine hydrochloride)
Catapres-TTS (clonidine) Transdermal Therapeutic System
Chlorascrub Swabsticks
Dexilant (dexlansoprazole)
Folotyn (pralatrexate injection)
Hibiclens (4% w/v chlorhexidine gluconate)
Hibistat (0.5% chlorhexidine gluconate solution and 70% isopropyl alcohol w/w)
Omeprazole/Sodium Bicarbonate/Magnesium Hydroxide Tablets
Prevacid (lansoprazole)
Protonix (pantoprazole sodium) For Injection
Protonix (pantoprazole sodium) For Delayed-Release Oral Suspension
Protonix (pantoprazole sodium) Delayed-Release Tablets
Scrub-Stat 2% and Scrub-Stat 4% (chlorhexidine gluconate 2% and 4%)     
Ultravist (brand of iopromide)
Ultravist (brand of iopromide) Injection Pharmacy Bulk Pack
Zarontin (ethosuximide)

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