FDA safety warning: Diabetes drug causes higher risk of foot, leg amputations

After reviewing the results of two large clinical trials, the Food and Drug Administration on Tuesday concluded the Type 2 diabetes treatment canagliflozin leads to increased risk of leg and foot amputations.

Here are four things to know.

1. One year-long study found 5.9 out of 1,000 diabetes patients treated with the drug — known by brand names Invokana and Invokamet — underwent an amputation. Only 2.8 of 1,000 patients taking a placebo experienced an amputation, according to an FDA report.

2. In a second trial, 7.5 out of 1,000 patients treated with the drug underwent an amputation, compared to just 4.2 out of 1,000 taking a placebo.

3. While removal of the toe and middle part of the foot were the most common, some patients did need leg amputations both below and above the knee, according to the report.

4. The FDA is requiring drugmakers — including Johnson & Johnson and Janssen Pharmaceuticals — to add a boxed warning about the amputation risks on the drug's label.

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