Three months after the Food and Drug Administration (FDA) warned that it was strengthening warnings on the type 2 diabetes drugs canagliflozin (Invokana and Invokamet) and dapagliflozin (Farxiga and Xigduo XR) regarding acute kidney injury, a new study claims the drugs may help protect kidney health.
People with type 2 diabetes are already at an increased risk of progressive kidney function loss and kidney disease. Researchers with the University Medical Center Groningen in the Netherlands who conducted the study said that SGLT2 inhibitors may offer therapeutic benefit to diabetics at risk of kidney problems. Three of the study’s authors are full-time employees of Janssen Research & Development, a subsidiary of Johnson & Johnson, which manufactures Invokana and Invokamet.
The findings are curious, considering in June the FDA announced that it was strengthening warnings regarding acute kidney injury with SGLT2 inhibitors and added recommendations to minimize the risk. The recommendations to health care professionals included considering factors that may predispose patients to acute kidney injury prior to prescribing 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,” the warning states.
Since March 2013, when canagliflozin was first approved, through October 2015, the FDA received reports of 101 confirmed cases of acute kidney injury, some requiring hospitalizations and dialysis, with canagliflozin or dapagliflozin.
“This number includes only reports submitted to FDA, so there are likely additional cases about which we are unaware,” the warning states. “In approximately half of the cases, the events of acute kidney injury occurred within one 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.”
Since SGLT2 inhibitors hit the market, the FDA has added new warnings or strengthened previous warnings regarding increased risk of bone fractures, bone mineral density loss, serious urinary tract infections and ketoacidosis, a condition in which too much acid builds up in the blood. The agency is currently investigating cases of lower limb amputations in patients who have used SGLT2 inhibitors.