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” available via the link below 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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