Diabetes drug raises risk of foot and leg amputation

FDA Issues Safety Alert for Canagliflozin

Based on new data from two large clinical trials, the FDA has concluded that the type 2 diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) causes an increased risk of leg and foot amputations.

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. The trials, dubbed Canvas and Canvas-R, showed that leg and foot amputations occurred twice as often in patients treated with Invokana vs. 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.

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The FDA's decision follows a MedWatch safety alert from this time previous year, which regulators issued after finding that patients in the Invokana arms of J&J's two cardiovascular outcomes studies for the med were about twice as likely to experience amputations than were those in the placebo groups. This warning is an update to the safety communication issued on May 18, 2016. Canagliflozin is SGLT2 inhibitor indicated to lower blood glucose levels in patients with type 2 diabetes along with diet and exercise.

FDA Drug Safety Communication: Interim clinical trial results find increased risk of leg and foot amputations, mostly affecting the toes, with the diabetes medicine canagliflozin (Invokana, Invokamet); FDA to investigate. The drugs help remove excess blood sugar through urine. Talk to your health care professional if you have questions or concerns.

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The warning comes as last May, the European Medicines Agency (EMA), the UK's Medicines and Healthcare products Regulatory Agency and Janssen told health professionals of the increased risk.

Untreated type 2 diabetes can cause blindness, nerve and kidney damage and heart disease.

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The FDA recommends patients taking canagliflozin notify their health care professional if they develop new pain or tenderness, sores or ulcers, or infections in the legs or feet. 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. Patients should also be monitored for the signs and symptoms of complications.

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