FDA strengthens drug safety warning for type 2 diabetes medicines

FDA has strengthened the existing warning about the risk of acute kidney injury for the type 2 diabetes medicines canagliflozin (Invokana, Invokamet—Janssen Pharms) and dapagliflozin (Farxiga, Xigduo XR—AstraZeneca). Based on recent reports, the agency has revised the warnings in the drug labels to include information about acute kidney injury and added recommendations to minimize this risk. From March 2013 to October 2015, FDA received reports of 101 confirmable cases of acute kidney injury, some requiring hospitalization and dialysis, with canagliflozin or dapagliflozin use. FDA recommends health care professionals consider factors that may predispose patients to acute kidney injury prior to starting them on canagliflozin or dapagliflozin. These include decreased blood volume; chronic kidney insufficiency; congestive heart failure; and taking other medications such as diuretics, blood pressure medicines, and nonsteroidal anti-inflammatory drugs. Read more at link above.
http://www.fda.gov/Drugs/DrugSafety/ucm505860.htm