Summary Safety Review - SGLT2 inhibitors - Assessing the potential risk of a rare brain condition (posterior reversible encephalopathy syndrome) in patients who have developed high levels of acids in the blood (diabetic ketoacidosis)

After receiving two Canadian case reports involving canagliflozin, Health Canada reviewed the potential risk of PRES in patients treated with SGLT2 inhibitors who have developed DKA. SGLT2 inhibitors have been linked to an increased risk of DKA, which is a serious complication of diabetes. Posterior reversible encephalopathy syndrome is a rare condition which can affect the brain and is characterized by sudden changes in the nervous system including headaches, confusion, seizures, and vision trouble. It can develop in association with many conditions, such as severe infection or DKA, and drugs. When PRES is caused by a drug, it is important to stop the use of the drug as soon as possible to avoid complications.