Can Farxiga cause kidney damage?
Medically reviewed by Drugs.com. Last updated on May 14, 2020.
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.
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
- Shortness of breath
- Muscle twitching or cramps
- Itchy skin
- Chest pain or pressure
- Seizures or coma in severe cases
Are some patients more at risk of kidney damage?
Patients who have renal impairment are thought to be at higher risk of acute kidney injury and more likely to experience hypotension (low blood pressure) while on Farxiga. Treatment with Farxiga is only recommended for patients with normal kidney (renal) function or those with mild impairment. It is not recommended for use in patients with moderate or severe impairment of their kidney function.
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.
- Food and Drug Administration (FDA). FDA Drug Safety Communication: FDA strengthens kidney warnings for diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR). June 14, 2016. [Accessed May 14, 2020]. Available online at: https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-strengthens-kidney-warnings-diabetes-medicines-canagliflozin.
- National Kidney Foundation. Acute Kidney Injury (AKI). [Accessed May 14, 2020]. Available online at: https://www.kidney.org/atoz/content/AcuteKidneyInjury.
- Food and Drug Administration (FDA). Farxiga. Highlights of Prescribing Information. [Accessed May 14, 2020]. Available online at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202293s020lbl.pdf.
- Diabetes.co.uk. SGLT2 Inhibitors (Gliflozins). January 15, 2019. [Accessed May 14, 2020]. Available online at: https://www.diabetes.co.uk/diabetes-medication/sglt2-inhibitors.html.
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