New Boxed Warning on Diabetes Drug

The US Food and Drug administration is requiring a new box warning to be added to the labels for the sodium-glucose cotransporter-2 (SGLT2) inhibitor canagliflozin (Invokana, Invokamet, Invokamet XR) after 2 large clinical trials showed that patients taking canagliflozin had foot and leg amputations almost 2 times more often than those taking the placebo.

This addition is an update to the safety alert issued last year after 1 of the 2 ongoing trials showed a possible link between foot and leg amputation risk and treatment with canagliflozin.
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The most common amputations were of the toe and middle of the foot, but amputations of the leg, both above and below the knee, occurred as well. In addition, some patients had more than one amputation, and some patients had amputations that included both limbs.

Health care professionals should consider risk factors for amputations before prescribing canagliflozin, including a history of prior amputation, peripheral vascular disease, neuropathy, and diabetic foot ulcers. Patients taking canagliflozin should be monitored for any signs and symptoms associated with an increased risk for amputation and canagliflozin should be discontinued if any complications occur.

—Melissa Weiss

Reference:

Canagliflozin (Invokana, Invokamet): drug safety communication - increased risk of leg and Foot amputations [press release]. FDA. May 16, 2017. https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm558605.htm. Accessed May 17, 2017.