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EC number: 604-045-2
CAS number: 137862-53-4
It can be summarized that repeated dosing of high doses of valsartan
(200 to 600 mg/kg/day) caused a reduction of red blood cell parameters
(erythrocytes, hemoglobin, hematocrit) and changes in renal hemodynamics
(slightly raised BUN, and renal tubular hyperplasia and basophilia in
males) in rats. In marmosets at comparable doses, the changes were
similar though more severe, particularly in the kidney where the changes
developed to nephropathy including raised BUN and creatinine.
Hypertrophy of the renal juxtaglomerular cells was also seen in both
species. All changes were considered to be caused by an exaggerated
pharmacological action of valsartan which produced prolonged
hypotension, particularly in marmosets.
Given the wealth of clinical data which have accumulated over the many
years of use in man, data on repeated dose toxicity in animals are not
considered of real relevance.
In controlled clinical studies in adult patients with hypertension, the
overall incidence of adverse reactions (ADRs) was comparable with
placebo and is consistent with the pharmacology of valsartan. The
incidence of ADRs did not appear to be related to dose or treatment
duration and also showed no association with gender, age or race.
The following events have been observed during clinical trials in
hypertensive patients irrespective of their causal association with the
study drug: arthralgia, asthenia, back pain,
diarrhea, dizziness, headache, insomnia, libido decrease, nausea, edema,
pharyngitis, rhinitis, sinusitis, upper respiratory tract infection,
Hypertensive patients with Impaired Glucose Tolerance at cardiovascular
In the NAVIGATOR study, adverse events with DIOVAN were similar to those
reported previously for patients with hypertension.
Post-myocardial infarction and/or heart failure
The safety profile seen in controlled-clinical studies in patients with
post-myocardial infarction and/or heart failure varies from the overall
safety profile seen in hypertensive patients. This may relate to the
patients underlying disease. ADRs that occurred in post-myocardial
infarction and/or heart failure patients are as follows:
Dizziness, postural dizziness (common); hypotension, orthostatic
hypertension (common); renal failure and impairment (common)
In addition to the safety experience gained from clinical trials,
analysis of adverse event reports received from the market since the
first introduction in 1996 has revealed very rare cases of angioedema,
rash, pruritus, and other hypersensitivity/allergic reactions including
serum sickness and vasculitis. Very rare cases of impaired renal
function have also been reported. In addition, myalgia was observed as a
rare adverse event with valsartan in a Prescription-Event-Monitoring
study of around 13,000 patients in England [CRD-49]. Another study of
monitoring adverse events in England reported that dyspnea was one of
the most commonly reported events in association with valsartan. Based
on post-marketing reports, several European countries have included the
occurrence of very rare cases of bleeding and thrombocytopenia in
association with valsartan into the local product information. Based on
post-marketing reports, hyponatremia was added to the local product
information in the EU.
Exposure in number of patient treatment years was calculated on the
basis of sales data assuming an average daily dose of one tablet per day
per patient. Total exposure to valsartan until 30 Apr 2014 is
approximately 95 million patient treatment years for adults and 28,654
patient treatment years for pediatric use based on the amount of
valsartan tablets sold.
(Ref.: Investigators Brochure, Edition 24, December, 2014)
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