Canagliflozin Products (Invokana and Invokamet) Potentially Associated With Increased Risk of Lower Limb Amputations
May 18, 2016
An interim analysis of the ongoing Canagliflozin Cardiovascular Assessment Study (CANVAS) revealed an association between canagliflozin and an increased risk of lower limb amputation. This trial compares 2 different dosages of canagliflozin against placebo and the average patient follow-up is 4.5 years. The annualized rate of lower limb amputation was 7/1,000 patients treated with canagliflozin 100 mg daily and 5/1,000 patients treated with canagliflozin 300 mg daily compared with 3/1,000 patients treated with placebo. Amputations were most commonly of toes. This association has not been seen in a similar trial, CANVAS-R, but patient follow-up time is a much shorter 9 months. FDA has not determined whether canagliflozin increases the risk of lower limb amputations and is still investigating this safety issue.
Canagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor used to treat adults with type 2 diabetes. It is available as a single agent (Invokana) and in combination with metformin (Invokamet). Health care professionals should follow the current prescribing information for canagliflozin and monitor patients for new sores, ulcers, or infections on their lower limbs. Patients should not stop taking canagliflozin without discussing the decision with their health care professional because uncontrolled blood sugar levels can cause serious health problems. Advise patients to contact their health care professional if they experience new pain or tenderness in their lower limbs or notice sores or ulcers on their legs or feet.
More information is available at the following links:
- FDA MedWatch Alert
- FDA Drug Safety Communication
May 18, 2016; University of Utah, Drug Information Service. Copyright 2016, Drug Information Service, University of Utah, Salt Lake City, UT.