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On June 14, 2016, the Food and Drug Administration (FDA) released another safety communication concerning the type 2 diabetes medication, Invokana (canagliflozin). It warned physicians and patients that Invokana and other similar medications (like Farxiga and Xigduo XR) can increase the risk of serious kidney injuries.

This follows another safety communication that was released last May, in which the FDA warned that the use of Invokana could increase the risk of diabetic ketoacidosis (DKA), a serious condition in which the blood becomes too acidic, causing symptoms like dehydration, shortness of breath, and unusual fatigue.

Over 100 Reports of Serious Kidney Injury Following New Invokana Prescription

Based on recent reports, the FDA is requiring stronger warnings on the labels for these drugs to include information about acute kidney injury. These drugs belong to a class called “sodium-glucose cotransporter-2 (SGLT2) inhibitors, which lower blood sugar by causing the kidneys to excrete it through the urine.

Between March 2013 and October 2015, the FDA received 101 reports of acute kidney injury in patients using the drugs. A total of 73 of these were connected with Invokana, while 28 were connected with other drugs (dapagliflozin).

Most of these patients were hospitalized for their conditions, and fifteen had to receive dialysis. The FDA believes that there were probably other similar cases that it is unaware of because they weren’t reported.

In about half the cases, the kidney injury occurred within one month of starting the drug, highlighting the need to watch patients carefully when they first start taking it. Among the 84 cases that reported an age, more than half were younger than 60 years. The median age of the patients was 57—they ranged in age from 28 to 79. Symptoms of serious kidney injury include decreased urine or swelling in the legs and feet.

In the 78 cases in which people stopped taking the drugs after experiencing problems, 56 reported improvement. Eleven didn’t recover, and four died.

Doctors Should Watch Out for Conditions that Increase the Risk of Kidney Injury

The FDA also warned healthcare professionals that some patients may not be suitable for Invokana because of preexisting health conditions. Those who have congestive heart failure, who are taking medications like diuretics or blood pressure medications, or who are already having kidney problems should look at alternative treatments for their diabetes.

The FDA also warned patients to talk to their doctors about their potential underlying risks for kidney problems. They advised patients to tell their doctors about all medications they are taking, including water pills, blood pressure medications, and nonsteroidal anti-inflammatory drugs like aspirin, ibuprofen, and naproxen.

This new FDA warning comes as a growing number of individuals are pursuing Invokana lawsuits around the country. Most involve allegations that the manufacturer failed to provide adequate warnings in the first place, and should have conducted additional safety studies before releasing the drug on the market.

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