Colistin-related risk of pseudo-Bartter syndrome

Excerpt

Colistin (colistimethate sodium) is associated with a risk of pseudo-Bartter syndrome, according to findings of a safety review conducted by Health Canada. The safety review was triggered by cases reported in scientific literature,Colistin is an antibacterial drug which is authorised in Canada for the treatment of acute and chronic infections, and is administered by injections in specialised settings such as hospitals.Health Canada reviewed all available evidence from searches of the Canada Vigilance database, international databases and scientific literature. At the time of the review, Health Canada had not received any Canadian reports of pseudo-Bartter syndrome related to the use of colistin. However, Health Canada reviewed seven international cases of pseudo-Bartter syndrome in patients who were administered colistin. All cases were found to be probably (n=6) or possibly (1) linked to the use of colistin.Adverse events reported in all cases included hypokalaemia, metabolic alkalosis, and loss of potassium in the urine. Some cases also reported hypomagnesaemia and hypocalcaemia. In all cases, electrolyte abnormalities resolved or significantly improved after colistin was discontinued.Health Canada considered that the available information found a link between the use of colistin and the risk of pseudo-Bartter syndrome, and is working with the manufacturers to update the Canadian product monograph for colistin-containing products with a warning about reported cases of pseudo-Bartter syndrome.Health Canada is encouraging patients and healthcare professionals to report any adverse events related to the use of colistin products to the Canada Vigilance Program. …