The FDA recently issued a Safety Communication warning type-2 diabetes patients they may be at increased risk for amputations if they take a widely used diabetes drug known by brand names Invokana or Invokamet. Canagliflozin, sold under brand names Invokana or Invokamet, is a sodium-glucose cotransporter-2 (SGLT2) inhibitor that works to lower blood sugar in adults suffering from type-2 diabetes, has been shown to increase the risk of extremity amputation with long-term use.
Interim safety results from clinical trials following patients taking canagliflozin for an average of 4.5 years showed these patients suffered twice as many incidents of foot and leg amputations, mostly involving toe amputations, as patients taking a placebo. Based on these findings, the FDA will conduct additional safety tests to investigate whether an increased risk of amputation comes with using canagliflozin drugs and will notify the public with any additional information.
Despite the FDA warning, diabetes patients are cautioned NOT to stop taking this medication without speaking first with their healthcare provider. Patients using this drug should be acutely aware of any new pain or changes in their pain, tenderness, sores or ulcers in their feet and legs, and should immediately notify their healthcare provider of any changes.
Healthcare providers who prescribe canagliflozin drugs should advise patients to notify them promptly if they begin to experience any of the above-listed symptoms in their extremities. Healthcare providers must closely monitor patients taking canagliflozin for these symptoms and are requested to notify the FDA of any reported side effects.
The FDA also asks patients to report any side effects experienced with canagliflozin use, or side effects with any other medication or medical devices, by filing a report with the FDA MedWatch program at www.accessdata.fda.gov/scripts/medwatch/
You can also download a report at www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM163919.pdf.
Or you can call the FDA at 800-332-1088.