FDA Medwatch-Drug Safety Labeling Changes

Looking For The Light


The FDA MedWatch-February 2016 Safety Labeling Changes 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

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