The FDA has announced it is adding a stronger warning about acute kidney problems to the label for Invokana and related diabetes medications.

The announcement was issued in a drug safety communication from June 2016. The agency says it will strengthen the existing warning about the risk of acute kidney injury associated with Invokana and certain other type 2 diabetes medications.

The new label will include recommendations for how patients can minimize the risk associated with Invokana side effects. The FDA says that doctors should consider the risks of Invokana side effects particularly in patients who are already predisposed to having kidney trouble.

The new warning applies to certain diabetes medications known as sodium-glucose cotransporter-2 inhibitors, or SGLT-2 inhibitors. These drugs help patients with type 2 diabetes keep their blood sugar levels under control by stimulating the kidneys to remove sugar from the blood and excrete it from the body through urine.

Canagliflozin, the generic name for the drug marketed as Invokana, is one of the SGLT-2 inhibitors affected by the new warning. Canagliflozin is also used in combination with metformin, one of the older diabetes medications, under the brand name Invokamet.

Both Invokana and Invokamet are products of Janssen Pharmaceuticals. The two medications are also both relatively new to the market, with Invokana having first been approved by the FDA in 2013 and Invokamet in 2014.

The FDA’s Reports on Diabetes Medications and Kidney Problems

The FDA says it based its decision to strengthen the warning on a review of reports of Invokana side effects and side effects associated with other drugs, filed through the agency’s Adverse Event Reporting System.

A review of reports filed between March 2013 and October 2015 revealed 101 reports of acute kidney problems associated with SGLT-2 inhibitors, 73 of which came from patients taking canagliflozin-based drugs like Invokana.

Of the total number of cases, the FDA says 96 had to be hospitalized, with 22 of those requiring admission to an intensive care unit. Fifteen patients had to be treated with dialysis.

Moreover, in over half of the cases, the patients’ acute kidney injury had an onset within one month or less of initiating the drug.

According to these reports, most of the patients who suffered Invokana side effects and discontinued the drug experienced improvement in their kidney symptoms. However, 11 patients did not recover, and four of those cases ended in death.

In the communication, the FDA encourages patients taking Invokana to seek medical attention immediately if they notice any signs or symptoms of acute kidney injury.

The agency says these signs and symptoms may include “decreased urine or swelling in the legs or feet.”

Other Possible Invokana Side Effects

The new warning about kidney problems comes not long after an earlier warning from May 2016, in which the FDA alerted to an increased risk of amputations associated with Invokana and Invokamet.

The agency said that interim results from an ongoing clinical trial found an increased incidence in leg and foot amputations, particularly involving the toes, among patients taking canagliflozin-based drugs.