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CANVAS and CANVAS-R, two large clinical trials that began in 2009 with 10,000 patients on canagliflozin or a placebo, released early data previous year that prompted the FDA to warn about amputation risks.

The US Food and Drug Administration (FDA) has announced that a new warning must be added to the label of Invokana (canagliflozin), a type 2 diabetes drug.

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The FDA observed that the results of one clinical trial showed that over the course of a year, the risk of amputation in patients treated with Invokana was equivalent to 5.9 out of 1,000, as against 2.8 out of 1,000 for patients given a placebo. 99 out of 140 amputated patients receiving the drug had their toe or mid-foot removed, while amputations involving the leg and the knee accounted for 41 out of 140 amputations. In May 2016 the FDA noted a correlation between Invokana and amputation risk, but required more evidence to prove causality. Canagliflozin is available through prescription as a single-ingredient drug, or in combination with metformin, sold as Invokamet. Talk to your health care professional if you have questions or concerns. It belongs to a class of drugs called sodium-glucose cotransporter-2 (SGLT2) inhibitors. It is recommended for use by diabetic adults along with diet and exercise to reduce levels of blood sugar. It will alert patients to be watchful and notify health care providers about ulcers, infections, or any new pain or tenderness in their legs and feet. Canagliflozin lowers blood sugar by causing the kidneys to remove sugar from the body through the urine. Do not stop taking your diabetes medicine without first talking to your physician. Patients now on the drug should be monitored closely for conditions such as infections and foot ulcers that may lead to amputation; the drug should be discontinued if these appear. After all, SGLT2 rival Jardiance from Eli Lilly and Boehringer Ingelheim has already showed it can cut the combined rate of heart attack, stroke and cardiovascular death in high-risk Type 2 patients, and J&J is crossing its fingers that its med can do the same in an upcoming trial. Patients with a baseline history of prior amputation, peripheral vascular disease, and neuropathy were found to be at greatest risk; clinicians should consider these risk factors prior to initiating treatment with canagliflozin.