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, according to Harris Martin.

According to a May 16 alert, the FDA is requiring the drug’s manufacturers to include a Boxed Warning regarding the risk of amputation to be added to the drug’s labeling.

The CANVAS (Canagliflozin Cardiovascular Assessment Study) trial showed that over a year, the risk of amputation for patients in the trial was equivalent to 5.9 out of every 1,000 patients treated with canagliflozin and 2.8 out of every 1,000 patients treated with placebo.

And the CANVAS-R (A Study of the Effects of Canagliflozin on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus) trial showed that over a year, the risk of amputation for patients in the trial was equivalent to 7.5 out of every 1,000 patients treated with canagliflozin and 4.2 out of every 1,000 patients treated with placebo.

The agency has cautioned health care professionals to consider factors that may predispose patients to the need for amputations before prescribing canagliflozin. Those factors include a history of prior amputation, peripheral vascular disease, neuropathy, and diabetic foot ulcers. Patients receiving canagliflozin should be monitored for those signs and symptoms and canagliflozin should be discontinued if such complications occur, the FDA says.

Invokana (canagliflozin) belongs to a class of drugs called Sodium Glucose Cotransporter 2 (SGLT2) Inhibitors, which aid the kidneys in lowering blood glucose levels in patients with type 2 diabetes. Janssen Pharmaceuticals Inc. manufactures Invokana.

Numerous lawsuits have been filed alleging that the drugs cause injuries, including diabetic ketoacidosis and kidney damage, and that the manufacturers failed to adequately test the drug and failed to properly warn users that injury could result from ingesting SGLT2s. In December, the federal lawsuits were transferred to a multidistrict litigation docket in the U.S. District Court for the District of New Jersey for coordinated pretrial proceedings.

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