FDA MedWatch - March 2010 Safety Labeling Changes: 40 drugs with changes to Boxed Warning, Warnings, Contraindications, Precautions, Adverse Reactions
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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)
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
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