lunes, 14 de marzo de 2016

FDA MedWatch - February 2016 Drug Safety Labeling Changes includes 21 products with revisions to Prescribing Information.

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MedWatch - The FDA Safety Information and Adverse Event Reporting Program

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:
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

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