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Characterized by the heart's inability to pump enough blood, the progressive disease affects some 5.1 million people in the United States. Heart attack, high blood pressure and other conditions that damage the heart are primary causes, the agency said in a news release.
"Heart failure is a leading cause of death and disability in adults," Dr. Norman Stockbridge, director of the division of cardiovascular and renal products in the FDA's Center for Drug Evaluation and Research, said in the news release. "Treatment can help people with heart failure live longer and enjoy more active lives."
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 (Vasotec). Most clinical trial participants also took standard heart failure medications, including beta blockers, diuretics and mineralocorticoid antagonists.
Common side effects of Entresto included low blood pressure, elevated blood potassium and impaired kidney function, according to the agency.
A more serious adverse effect was angioedema, an allergic reaction characterized by swelling of the lips or face. Blacks and people with a history of angioedema are at higher risk of this reaction, the FDA said. People taking the drug should seek immediate medical help if they develop facial swelling or trouble breathing, the agency said.
Entresto should not be used with any ACE inhibitor drug, 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.
Entresto is produced by Novartis, based in East Hanover, N.J.
-- Scott Roberts
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