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The MedWatch November 2014 Safety Labeling Changes posting includes 30 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT.
The "Summary Page" table provides a listing of product names and safety labeling sections revised:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm425985.htm
The following drugs had modifications to the CONTRAINDICATIONS, or WARNINGS and PRECAUTIONS sections:
Adcetris (brentuximab vedotin) for Injection
Arava (leflunomide) Tablets
AVELOX (moxifloxacin hydrochloride) Tablets and IV
Bosulif (bosutinib) Tablets
Cardizem (diltiazem hydrochloride) Tablets
Cubicin (daptomycin for injection) Intravenous
Cymbalta (duloxetine) Delayed-release Capsules
Foscavir (foscarnet sodium) Injection
Lopid (gemfibrozil) Tablets
Mycobutin (rifabutin) Capsules
Mytelase (ambenonium chloride) Tablets
Sensipar (cinacalcet hydrochloride) Tablets
Sovaldi (sofosbuvir) Tablet
Sylatron (peginterferon alfa-2b)
Taxotere (docetaxel) Injection Concentrate
Unasyn (ampicillin sodium/sulbactam sodium) Injection
Votrient (pazopanib hydrocholoride) Tablets
Zelboraf (vemurafenib) Tablet
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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