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From the long term data in the Valsartan Heart Failure Trial, there did not appear to be any significant adverse events not previously identified. Post-Marketing Experience The following additional adverse reactions have been reported in post-marketing experience: Text Continues Below
Hypersensitivity: There are rare reports of angioedema; Digestive: Elevated liver enzymes and very rare reports of hepatitis; Renal: Impaired renal function; Clinical Laboratory Tests: Hyperkalemia; Dermatologic: Alopecia. Clinical Laboratory Test Findings
In controlled clinical trials, clinically important changes in standard laboratory parameters were rarely associated with administration of Diovan. Creatinine: Minor elevations in creatinine occurred in 0.8% of patients taking Diovan and 0.6% given placebo in controlled clinical trials of hypertensive patients. In heart failure trials, greater than 50% increases in creatinine were observed in 3.9% of Diovan-treated patients compared to 0.9% of placebo-treated patients. Hemoglobin and Hematocrit: Greater than 20% decreases in hemoglobin and hematocrit were observed in 0.4% and 0.8%, respectively, of Diovan patients, compared with 0.1% and 0.1% in placebo-treated patients. One valsartan patient discontinued treatment for microcytic anemia. Liver function tests: Occasional elevations (greater than 150%) of liver chemistries occurred in Diovan-treated patients. Three patients (< 0.1%) treated with valsartan discontinued treatment for elevated liver chemistries. Neutropenia: Neutropenia was observed in 1.9% of patients treated with Diovan and 0.8% of patients treated with placebo.
Serum Potassium:
In hypertensive patients, greater than 20% increases in serum potassium were observed in 4.4% of Diovan-treated patients compared to 2.9% of placebo-treated patients. In heart failure patients, greater than 20% increases in serum potassium were observed in 10.0% of Diovan-treated patients compared to 5.1% of placebo-treated patients. Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
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