OmniPod Insulin Management System by Insulet: There are reported cases of needle mechanism deployment failure or delay.  The affected Pod lots have resulted in 66 medical device reports, of which three required medical intervention. See the Press Release for a listing of affected product lots.


FDA Adds New Warnings on SGLT2 Inhibitors: Calls attention to ketoacidosis, UTI risks.  The FDA said Friday that SGLT2 (sodium-glucose cotransporter-2) inhibitors such as empagliflozin (Jardiance), dapagliflozin (Farxiga), and canagliflozin (Invokana) will need new warnings on the risks of ketoacidosis, urinary tract infections, and other serious illnesses.  More than 70 cases of ketoacidosis have been reported to the agency, as well as 19 “life-threatening” cases of urosepsis and pyelonephritis, according to an FDA drug safety communication.