(RxWiki News) The US Food and Drug Administration (FDA) has approved the first diabetes medication of its class to treat a certain type of heart failure.
Available in tablet form, this medication appears to lower the risk of cardiovascular death and hospitalization tied to heart failure.
Heart failure happens when the heart does not pump enough blood to support what the body needs. In the type of heart failure that Farxiga has been approved to treat (reduced ejection fraction), the heart's left ventricle is weak, which means the heart can't pump enough blood.
“Heart failure is a serious health condition that contributes to one in eight deaths in the U.S. and impacts nearly 6.5 million Americans,” said Dr. Norman Stockbridge, director of the FDA's Division of Cardiology and Nephrology, in a press release. “This approval provides patients with heart failure with reduced ejection fraction an additional treatment option that can improve survival and reduce the need for hospitalization."
The recommended dose of Farxiga to lower the risk of hospitalization for heart failure is 10 mg once daily, according to the FDA. The safety and effectiveness of dapagliflozin was studied in a randomized, double-blind, placebo-controlled study of nearly 5,000 participants.
Common side effects of dapagliflozin include urinary tract infections and genital yeast infections. Serious side effects may include low blood pressure and ketoacidosis (acid buildup in the blood).
Farxiga is already approved, in combination with diet and exercise, to treat adults with type 2 diabetes. This medication is also approved to lower the risk of hospitalization due to heart failure in those with type 2 diabetes and other risk factors.
This new approval was granted to AstraZeneca Pharmaceuticals LP Wilmington, DE.
Speak with your health care provider if you have any questions.