FDA issues warning against canagliflozin as it increases amputation risk

Glen Mclaughlin
May 18, 2017

Canagliflozin is one of the new class of SGLT-2 inhibitors that reduce blood glucose levels by inducing sugar to be excreted in urine. Excessive urination can potentially cause dehydration and blood volume depletion in high-risk patients that exacerbates circulatory problems.

Based on new data from two large clinical trials, the Food and Drug Administration has concluded that type 2 diabetes drug Invokana (canagliflozin) poses an increased risk of leg and foot amputations.

Researchers also found that the risk of amputation in patients treated with Invokana in one year was equivalent to 5.9 out of every 1,000 patients as compared with 2.8 out of every 1,000 patients who were given a placebo.

The Boxed Warning is an update to a May 18, 2016, safety alert for canagliflozin (Invokana, Janssen), which strengthened the existing warning about the risk for acute kidney injury in patients; it is also available in combination with metformin under the brand name Invokamet. This is a risk-factor for infections that do not heal very well, otherwise known as ulcers, and tissue necrosis that requires amputation.

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Most of the amputations were of toes or the middle of the foot, but some patients needed their entire foot or leg removed, sometimes even above the knee.

The FDA advised patients taking canagliflozin to notify their health care professionals right away if they develop new pain or tenderness, sores or ulcers, or infections in the legs or feet. Factors that increase the risk of amputation include a history of a peripheral vascular disease, previous amputations, and neuropathy.

The study was focused on determining how canagliflozin affected the renal endpoints in adults with type 2 diabetes. Despite the increased risk of amputation, patients should not stop treatment for type 2 diabetes without discussing options with their providers, according to the release. However, amputations of the leg, below and above the knee, also occurred, and some patients had more than 1 amputation. However, in two clinical trials of the drug canagliflozin, marketed as Invokana, Invokamet, and Invokamet XR, patients taking the drug were twice as likely to need amputations. Healthcare professionals and patients can report adverse effects related to canagliflozin and other medicines to the FDA MedWatch program.

Other reports by MaliBehiribAe

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