Moda Health. Healthcare from your head to your toes. Delta Dental | Moda Health

FDA Drug Safety Communication: FDA strengthens kidney warnings for diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR)

The U.S. Food and Drug Administration (FDA) has strengthened the existing warning about the risk of acute kidney injury for the type 2 diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR). Based on recent reports, we have revised the warnings in the drug labels to include information about acute kidney injury and added recommendations to minimize this risk.

Patients should seek medical attention immediately if they experience signs and symptoms of acute kidney injury. This is a serious condition in which the kidneys suddenly stop working, causing dangerous levels of wastes to build up in the body. Signs and symptoms of acute kidney injury may include decreased urine or swelling in the legs or feet. Patients should not stop taking their medicine without first talking to their health care professionals. Doing so can lead to uncontrolled blood sugar levels that can be harmful.

Health care professionals should consider factors that may predispose patients to acute kidney injury prior to starting them on canagliflozin or dapagliflozin. These include decreased blood volume; chronic kidney insufficiency; congestive heart failure; and taking other medications such as diuretics, blood pressure medicines called angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs), and nonsteroidal anti-inflammatory drugs (NSAIDs). Assess kidney function prior to starting canagliflozin or dapagliflozin and monitor periodically thereafter. If acute kidney injury occurs, promptly discontinue the drug and treat the kidney impairment.

Canagliflozin and dapagliflozin are prescription medicines used with diet and exercise to help lower blood sugar in adults with type 2 diabetes. They belong to a class of drugs called sodium-glucose cotransporter-2 (SGLT2) inhibitors. Canagliflozin and dapagliflozin lower blood sugar by causing the kidneys to remove sugar from the body through the urine. Untreated, type 2 diabetes can lead to serious problems, including blindness, nerve and kidney damage, and heart disease.

From March 2013, when canagliflozin was approved, to October 2015, FDA received reports of 101 confirmable cases* of acute kidney injury, some requiring hospitalization and dialysis, with canagliflozin or dapagliflozin use (see Data Summary). This number includes only reports submitted to FDA, so there are likely additional cases about which we are unaware. In approximately half of the cases, the events of acute kidney injury occurred within 1 month of starting the drug, and most patients improved after stopping it. Some cases occurred in patients who were younger than 65 years. Some patients were dehydrated, had low blood pressure, or were taking other medicines that can affect the kidneys.

We urge health care professionals and patients to report side effects involving canagliflozin, dapagliflozin, or other medicines to the FDA MedWatch program.

Moda Health Provider Network

Find a physician, pharmacy or clinic

Opt in for medical

Tell us you're interested and we'll be in touch with details.

Get Started  Get Started

Questions?

If you can't find an answer, please feel free to contact our Customer Service Customer Service Customer Service

Questions?

If you can't find an answer, please feel free to contact our Customer Service

Employer web tools

Benefit Tracker

Check benefits and eligibility

Log in

Account help

Request an account

Provider Reports

For value-based provider programs, including Synergy, Summit, Beacon, Affinity, CPC+, and EOCCO

Log in

Join our email list


Benefit Tracker

Check benefits, eligibility, incentive and utilization

Log In

Account help

Create an account

Producer web tools


Hello.

We have exciting news to share. ODS is changing its name to Moda Health.

Moda comes from the latin term "modus" and means "a way". We picked it because that's what we are here to do: help our communities find a way to better health.

Together, we can be more, be better.

Please select the state you live in, or the state where your employer is headquartered, so we can tailor your experience:

Hello.

Please select the state you live in, or the state where your employer is headquartered, so we can tailor your experience:

Changing your location to Oregon

You can return to your previous location in the site header.