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 on its website Tuesday.
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.