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The MedWatch August 2010 Drug Safety Labeling Changes posting includes 24 products with safety labeling changes to the following sections: 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/ucm225299.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.
The following drugs had modifications to the CONTRAINDICATIONS and WARNINGS sections:
Advil Allergy Sinus (ibuprofen, chlorpheniramine maleate, and pseudoephedrine)
Aleve (naproxen sodium)
Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate)
Biltricide (praziquantel)
Childrens Advil Cold (ibuprofen and pseudoephedrine)
Cubicin (daptomycin)
Exelon Patch (rivastigmine)
Flagyl (metronidazole)
Heparin Sodium in the 5% Dextrose injection and in the 0.9% Sodium Chloride injection
Meridia (sibutramine hydrochloride)
Plavix (clopidogrel bisulfate)
Risperdal (risperidone)
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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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