Updated FDA Safety Alert: Invokana and Invokamet for Diabetes

Roni Shye
Roni Shye, PharmD BCGP BCACP, is a licensed pharmacist in the states of Florida, Ohio, and Pennsylvania.
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On May 16th, 2017, the FDA issued an update on canagliflozin-containing medications, like Invokana and Invokamet, as part of a year-long ongoing review.

This update is the result of new data from the CANVAS and CANVAS-R clinical trials. This research showed that leg and foot amputations occurred two times more often in patients treated with canagliflozin than in patients who were given a placebo sugar pill. Amputations of the toe and foot were the most common; however, amputations involving the leg and knee also occurred.

Because of this finding, the FDA is now requiring manufacturers of these medications to add new warnings to drug labels, including a Black Boxed Warning.

What are these medications indicated for?

Invokana, Invokamet, and Invokamet XR are indicated, in addition to diet and exercise, for the treatment of type 2 diabetes. Doctors prescribe a canagliflozin-containing medication if the benefits of one of these medications outweigh any of their risks or serious side effects.

Before prescribing a canagliflozin-containing medication, your healthcare provider should consider your history of prior amputation, peripheral vascular disease, neuropathy and diabetic foot ulcers.

What signs and symptoms should a person prescribed a canagliflozin-containing medication look out for?

If you have been prescribed a canagliflozin-containing medication and think you are experiencing a severe side effect, some signs you should look out for include new pain or tenderness, sores or ulcers, or infections in your legs and feet.

Be sure to speak with your doctor if you experience any of these side effects. Do not stop taking any medication for your diabetes without talking to your healthcare provider. Doing so can lead to uncontrolled blood sugar levels that can be harmful. Over time, this can cause serious problems like blindness, nerve and kidney damage and heart disease

Are there any similar medications my doctor could switch me to?

Yes. Both Jardiance (empagliflozin) and Farxiga (dapagliflozin) work just like canagliflozin.

At this time, only medications containing canagliflozin are of concern. The FDA has not issued any safety communications or warnings about other medications in the SGLT-2 inhibitor class.

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