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The MedWatch February 2016 Safety Labeling Changes posting includes 21 products with safety labeling changes to the following sections: CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE.
The "Summary Page" table provides a listing of product names and safety labeling sections revised:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm489329.htm
The following drugs had modifications to the CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS sections:
Atacand (candesartan cilexetil) Tablets
Atacand HCT (candesartan cilexetil/hydrochlorothiazide)
Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate) Tablets
Avalide (irbesartan/hydrochlorothiazide) Tablets
Cimzia (certolizumab pegol) Lyophilized Powder and Solution for Subcutaneous Use
Complera (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) Tablets
Depacon (valproate sodium) Injection
Depakene (valproic acid) Capsules
Depakene (valproic acid) Oral Solution
Depakote (divalproex sodium) Delayed Release Tablets
Depakote ER (divalproex sodium) Extended Release Tablets
Depakote Sprinkle Capsules
Fluorescite (fluorescein injection)
Fosrenol (lanthanum carbonate) Chewable Tablets and Oral Powder
Gilenya (fingolimod) Capsules
Invirase (saquinavir mesylate) Capsules and Tablets
Stribild (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate) Tablets
Tecfidera (dimethyl fumarate)
Truvada (emtricitabine/tenofovir disoproxil fumarate) Tablets
Vistaril (hydroxyzine pamoate) Capsules and Oral Suspension
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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