The MedWatch March 2010 Drug Safety Labeling Changes posting includes 40 drug products with safety labeling changes

The MedWatch March 2010 Drug Safety Labeling Changes posting includes 40 drug products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE.

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

http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm207384.htm

Clicking on a drug product name in the Summary View will take you to the "detailed view" page, which identifies safety labeling sections and subsections revised, along with a brief summary of new or modified safety information to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections.

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


Plavix (clopidogrel bisulfate)
Caduet (amlodipine besylate/atorvastatin calcium)
Lotrel (amlodipine besylate/benazapril hydrochloride)
Meridia (sibutramine hydrochloride)
Skelid (tiludronate disodium)
Avelox (moxifloxacin)
ChloraPrep [chlorhexidine gluconate (2% w/v) and isopropyl alcohol (70% v/v)]
DuraPrep Surgical (iodine povacrylex (0.7% available iodine) and isopropyl alcohol (74% w/w)
Emend (fosaprepitant dimeglumine)
Femara (letrozole)
Fosamax Plus D (alendronate sodium/cholecalciferol)
Hycamtin (topotecan hydrochloride)
Rapaflo (silodosin)
Sustiva (efavirenz)
Toprol XL (metoprolol succinate)
Vivitrol (naltrexone for extended-release)
Vytorin (ezetimibe/simvastatin)
Zocor (simvastatin)