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Label Changes for:

Diovan HCT (Valsartan/Hydrochlorothiazide)

August 2012

Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – April 2010, June and December 2011, February and August 2012


August 2012



  • Monitor renal function and potassium in susceptible patients
Potassium Abnormalities
  • Valsartan:Some patients with heart failure have developed increases in potassium with Diovan therapy…