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Invokana, Invokamet may increase amputation risk

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Interim safety results from an ongoing clinical trial have linked Invokana and Invokamet to an increased risk for leg and foot amputations, according to a press release from the FDA.

The FDA is currently investigating the possible safety issue but has not determined whether Invokana (canagliflozin, Janssen) and Invokamet (canagliflozin, Janssen) increase the risk.

Patients should not change or stop their medications without talking to their physician. Health care providers of patients prescribed these medications should follow the recommendations in the drug labels as well as monitor patients.

In the ongoing Canagliflozin Cardiovascular Assessment Study (CANVAS), over 1 year, amputations occurred in seven out of every 1,000 patients treated with 100 mg daily of canagliflozin, five out of every 1,000 patients treated with 300 mg daily and three out of every 1,000 patients treated with placebo.