FDA MedWatch - May 2012 Safety Labeling Changes includes 41 products with revisions to Prescribing Information

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.

Jun 14th, 2012


The "Summary Page" provides a listing of drug names and safety labeling sections revised.

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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