Novartis' heart failure drug needs monitoring for safety, says AdverseEvents

17 July 2015

Independent research on Entresto (sacubitril and valsartan), Swiss drug major Novartis’ (VX:NOVN) new heart failure drug, has asked for a post-market safety analysis to monitor the increased risk of angioedema and falls observed during clinical trials and a potential theoretical risk of developing Alzheimer's disease.

The research published by US independent informatics company AdverseEvents said that in addition to the already established risks there are some serious off-label RxSignals for adrenal insufficiency, rhabdomyolysis and psychiatric side effects.

The US Food and Drug Association earlier this month approved Novartis’ Entresto that has shown significant reduction in mortality and hospitalization.

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