Can Farxiga cause kidney damage?

• Farxiga may cause acute kidney injury

• Signs to watch out for include urinating less or swelling in you legs or feet

• Before starting Farxiga your doctor will determine if you are at increased risk for acute kidney injury

Sodium-glucose cotransporter 2 (SGLT2) inhibitors, including Farxiga (dapagliflozin), may cause acute kidney injury (AKI), according to the results of postmarketing studies. Farxiga’s product label and Medication Guide provide warnings about the risk of kidney injury.

Some of the patients who developed AKI while taking a SGLT2 inhibitor, which are also known as gliflozins, required hospitalization and dialysis. At the time the initial post-marketing studies were done, Farxiga had only been approved for use in patients with type-2 diabetes mellitus so all the cases of AKI were reported in such patients. Farxiga was subsequently approved for the treatment of heart failure in May 2020 and chronic kidney disease (CKD) in April 2021.

What is acute kidney injury?

AKI is a sudden episode of kidney failure or damage. It has a rapid onset over the course of a few hours or days and results in the build-up of waste products in the blood. It also makes it difficult for the kidneys to regulate the level of fluid in the body.

What are the signs and symptoms of acute kidney injury?

In some cases patients may not have obvious signs or symptoms of AKI. However, signs and symptoms that do suggest AKI include:

• Decreased urine output
• Swelling in the legs or feet
• Tiredness
• Shortness of breath
• Nausea
• Muscle twitching or cramps
• Itchy skin
• Confusion
• Chest pain or pressure
• Seizures or coma in severe cases

But isn’t Farxiga used to treat chronic kidney disease?

In April 2021, the US Food and Drug Administration (FDA) approved Farxiga to reduce the risk of kidney function decline, kidney failure, cardiovascular death and hospitalization for heart failure in adults with CKD who are at risk of disease progression.

A large phase III trial called DAPA-CKD, which was conducted in patients with or without diabetes who had CKD stages 2-4, found that treatment with Farxiga was beneficial in this group of patients and prolonged survival. Patients with stage 2 kidney disease have a mild form of kidney disease, while those with stage 4 disease have moderate to severe damage to their kidneys.

Despite being approved for use in certain patients with CKD, Fargixa is not recommended for the treatment of type 2 diabetes in patients with a estimated glomerular filtration rate (eGFR) of less than 45 ml/min/1.73m², which indicates stage 3 kidney disease.

Before prescribing Farxiga, doctors will also consider factors such as whether you have congestive heart failure, decreased blood volume, or take medications such as a diuretic, angiotensin-converting enzyme (ACE) inhibitor, angiotensin receptor blocker (ARB) or nonsteroidal anti-inflammatory drug (NSAID), which may put you at greater risk of developing AKI while taking Farxiga.