Entresto was evaluated in clinical trials involving more than 8,000 adults. It was shown to reduce the rate of cardiovascular death and hospitalization, compared to the drug enalapril. Most clinical trial participants were taking currently approved medications for heart failure, including β-blockers, diuretics, and mineralocorticoid antagonists.
Common side effects of Entresto included hypotension, hyperkalemia, and renal impairment, according to the agency. A more serious adverse effect was angioedema. Blacks and those with a history of angioedema are at higher risk of this reaction, the FDA said. Entresto should not be used with any angiotensin converting enzyme inhibitor, which would increase a user’s risk of angioedema. And women should discontinue Entresto as soon as possible if they become pregnant, the FDA warned.
“Heart failure is a leading cause of death and disability in adults,” Norman Stockbridge, MD, PhD, director of the division of cardiovascular and renal products in the FDA’s Center for Drug Evaluation and Research, said in a statement. “Treatment can help people with heart failure live longer and enjoy more active lives.”
Entresto is produced by Novartis, based in East Hanover, N.J.
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