Canagliflozin is used for patients with type 2 diabetes that are not currently using insulin. It works by reducing the amount of glucose (sugar in the blood) that is reabsorbed in the kidneys. This increases the amount of glucose that ends up in the urine, ultimately lowering the concentration of glucose in the blood stream.
The Food and Drug Administration added a boxed warning to the label of canagliflozin for the risk of lower limb amputation. There is an approximately 2-fold increase in the risk of needing a lower limb amputation when canagliflozin is used. This was found in two clinical trial CANVAS (Canagliflozin Cardiovascular Assessment Study) and CANVAS-R (A Study of the Effects of Canagliflozin on Renal Endpoints in Adult Participants with Type 2 Diabetes Mellitus). Both trials were large involving more than 10,000 patients, randomized, placebo-controlled trials in patients with type 2 diabetes.
The most common amputations reported in the trials were amputations of the toes and midfoot while amputations involving the leg (both below and above the knee) were also observed. The trials found that some patients experienced multiple amputations on both legs.
These trials followed the patients for an average of 5.7 years and 2.1 years. They found that lower-limb infections, gangrene, diabetic foot ulcers, and signs of lack of blood flow commonly occurred prior to the need for amputation.
Prior to using this medication, a careful assessment of factors that increase the risk of amputation need to be taken into account. These include any history of prior amputation, peripheral vascular disease, diabetic foot ulcers, and neuropathy.
The FDA also advises physicians to consider the discontinuation of this medication in patients that have elevated cholesterol, fragility fractures, yeast infections, episodes of low blood sugar, urinary tract infections, low blood pressure, and elevated potassium levels.
Report any adverse events involving canagliflozin or any drug to FDA MedWatch program.
The Metabolism Clinic is established as the destination for weight loss and reversal of diabetes. Based in Charlotte, North Carolina. www.themetabolismclinic.com