FDA Medwatch-Drug Safety Labeling Changes


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
Vistaril (hydroxyzine pamoate) Capsules and Oral Suspension

Complete and submit the report Online: http://www.fda.gov/MedWatch/report.
Download form or call 1-800-332-1088 to request a reporting form. Then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178



  1. Thank you this is such an important resource. I also think you raising awareness in an area (certainly within the Canadian Health Care system) where there is no mandatory reporting mechanism of adverse events of drugs. It’s something that not all people are doctor’s report so there is not great data about drugs that often behave quite differently once they are in the real world than they do in a clinical trial. It’s important as a patient to always be aware of the risk and to be clear about their own threshold for risk because there is also the reward component of most therapies. It’s a big picture, thanks for shining some light onto it. With respect, Harlon


    • Hi Harlon
      When I was diagnosed as Bipolar it took years before I paid attention. I’ve spent so many years taking care of grandparents as they died or sick myself. I have Chronic Lyme Disease, and take several IV therapies and about 50 pills. I know you can relate to the long struggle to get well or close.Canada is very difficult when it come to long term care. I’m glad you left your feedback. I have learned much by surfing and learning how to read doctor’s codes.
      I hope you have a great weekend.

      Liked by 1 person

I appreciate your comments, what you have to say is important. Thank you.

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