Label Changes for:
Diovan HCT (Valsartan/Hydrochlorothiazide)
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
WARNINGS AND PRECAUTIONS
- Monitor renal function and potassium in susceptible patients
- Valsartan:Some patients with heart failure have developed increases in potassium with Diovan therapy…