WASHINGTON D.C. — The U.S. Food and Drug Administration has issued a new safety alert that the diabetes drug canagliflozin (Invokana) has been associated with an increase in leg and foot amputations — largely affecting the toes.
The safety communication was released Wednesday.
The FDA is reportedly investigating the safety issue, but has yet to determine if taking canagliflozin (Invokana) is associated with an increased risk of leg and foot amputations.
The alert comes on the heels of a four-year interim analysis, completed by the independent monitoring committee for the Canagliflozin Cardiovascular Assessment Study (CANVAS).
The panel reportedly found that the rate of amputations — mostly of the toes — per every 1000 patients was equivalent to seven for 100 mg/day and five for 300 mg/day of canagliflozin — compared with three per 1000 patients taking placebo.
“Patients should not stop or change their diabetes medicines without first talking to their health care professional,” the communication states. “Doing so can lead to uncontrolled blood sugar levels that can be harmful. Over time, this can cause serious problems, including blindness, nerve and kidney damage, and heart disease.
“Patients taking canagliflozin should notify their health care professionals right away if they notice any new pain or tenderness, sores or ulcers, or infections in their legs or feet.”
The safety alert was issued nearly two weeks after the European Medicines Agency (EMA) announced that it was conducting an investigation into reports of lower limb amputations.
The FDA and EMA both approved Invokana in 2013 as a treatment for type 2 diabetes.
The FDA warned in a safety communication in May 2015 that these drug treatments may put patients at risk for a serious health condition known as ketoacidosis. Ketoacidosis occurs when the cells do not receive the glucose needed by the body for energy and begins to burn fat for energy, which produces ketones. When ketones build up in the blood, it becomes more acidic and can poison the body.
The FDA continues to investigate potential complications caused by Invokana, and claims are being investigated against the drug manufacturer, Janssen Research & Development, LLC, for failing to produce a safe and reliable medication.
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