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The FDA is strengthening a warning on the labels of two diabetes drugs to reflect risk of acute kidney injuries.
New labels for the two sodium-glucose transport 2 (SGLT-2) drugs -- canagliflozin (Invokana) and dapagliflozin (Farxiga) -- will have more information about acute kidney injuries and add recommendations about how to minimize risk, said the FDA .
The agency says that the strengthened warning comes after they have received reports of 101 confirmable cases of acute kidney injury from March of 2013 to October of 2015. Some of those cases required hospitalization and dialysis. "This number includes only reports submitted to FDA, so there are likely additional cases about which we are unaware," according to the posted statement.
It added that healthcare professionals should consider factors that could predispose somebody to acute kidney injury like any of the following:
- decreased blood volume
- chronic kidney insufficiency
- congestive heart failure
- taking other medications such as diuretics, 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," recommended the agency. "If acute kidney injury occurs, promptly discontinue the drug and treat the kidney impairment."
A stated that in about half of the cases, the acute kidney injury within 1 month of starting the drug, and that most patients improved after discontinuing the drug. The warning does not apply to a third drug in the same class, empagliflozin (Jardiance), which was recently reported to be associated with a slower progression of kidney disease than placebo.
A study reported at the annual meeting of the American Diabetes Association found that canagliflozin was associated with slower decline of kidney function in diabetic patients. Robert Eckel, MD, of the University of Colorado School of Medicine said after looking at those results that they weren't surprising. "We have seen in other studies that drugs in this class appear to have renal benefits. I think that what was seen with canagliflozin in this study is a class effect of the SGLT-2 drugs," he said.
One of the authors of that study, , of the University of Groningen in the Netherlands, told Medpage Today that the evidence that they saw was obtained from a randomized controlled trial, and not real-world condiditions. It is possible that the SGLT-2 inhibitors are prescribed less carefully in the real world, and Heerspink pointed out that the observed associations between acute kidney injury and SGLT-2 use "do not suggest causality."
As to why empagliflozin was not included in the warning, Heerspink gues that it might be because empagliflozin "is is not often used in the U.S., and there are only few post-marketing reports related to empagliflozin."
The FDA asked that adverse events related to these drugs be reported to its .