Label Changes for:

Diovan (valsartan) Tablets and Diovan HCT (valsartan/hydrochlorothiazide)

July 2012

Changes have been made to the CONTRAINDICATIONS, 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) – July 2012

 

 

CONTRAINDICATIONS

  • Do not use in patients with known hypersensitivity to any component.

WARNINGS AND PRECAUTIONS

Impaired Renal Function
  • Changes in renal function including acute renal failure can be caused by drugs that inhibit the renin-angiotensin system and by diuretics. Patients whose renal function may depend in part on the activity of the reninangiotensin system (e.g. patients with renal artery stenosis, chronic kidney disease, severe congestive heart failure, or volume depletion) may be at particular risk of developing acute renal failure on Diovan. Monitor renal function periodically in these patients. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function on Diovan.
Hyperkalemia
  • Some patients with heart failure have developed increases in potassium. These effects are usually minor and transient, and they are more likely to occur in patients with pre-existing renal impairment. Dosage reduction and/or discontinuation of Diovan may be required

ADVERSE REACTIONS

Heart Failure
  • About 93% of patients received concomitant ACE inhibitors. Discontinuations occurred in 0.5% of valsartan-treated patients and 0.1% of placebo patients for each of the following:
  • elevations in creatinine and elevations in potassium.
Post-Myocardial Infarction
  • Discontinuations due to renal dysfunction occurred in 1.1% of valsartan-treated patients and 0.8% of captopril-treated patients.
Post-Marketing Experience

Hypersensitivity

  • Some of these patients previously experienced angioedema with other drugs including ACE inhibitors. Diovan should not be re-administered to patients who have had angioedema.

Renal

  • renal failure

DRUG INTERACTIONS

CYP 450 Interactions
  • In vitro metabolism studies indicate that CYP 450 mediated drug interactions between valsartan and co-administered drugs are unlikely because of the low extent of metabolism.
Potassium
  • Concomitant use of valsartan with other agents that block the renin-angiotensin system, potassium sparing diuretics (e.g., spironolactone, triamterene, amiloride), potassium supplements, or salt substitutes containing potassium may lead to increases in serum potassium and in heart failure patients to increases in serum creatinine. If co-medication is considered necessary, monitoring of serum potassium is advisable.
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