Welcome to the FDA Drug Safety Podcast for health care professionals from the Division of Drug Information. This is Lesley Navin Advanced Practice Nurse.
On May 16, 2017, based on new data from two large clinical trials, the FDA concluded that the type 2 diabetes medicine canagliflozin (brand names Invokana, Invokamet, Invokamet XR) causes an increased risk of leg and foot amputations. We are requiring new warnings, including our most prominent Boxed Warning, be added to the canagliflozin drug labels to describe this risk.
Health care professionals should consider factors that may predispose patients to the need for amputations before starting canagliflozin, including history of prior amputation, peripheral vascular disease, neuropathy, and diabetic foot ulcers. Monitor patients receiving canagliflozin and discontinue if these complications occur.
Untreated, type 2 diabetes can lead to serious problems, including blindness, nerve and kidney damage, and heart disease. Canagliflozin belongs to a class of drugs called sodium-glucose cotransporter-2 (SGLT2) inhibitors and lowers blood sugar by causing the kidneys to remove sugar from the body through the urine.
Final results from two clinical trials –CANVAS (Canagliflozin Cardiovascular Assessment Study) and CANVAS-R (A Study of the Effects of Canagliflozin on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus) – showed that leg and foot amputations occurred twice as often in patients treated with canagliflozin compared to patients treated with placebo. The CANVAS trial showed that over a year’s time, the risk of amputation for patients in the trial were equivalent to:
- 5.9 out of every 1,000 patients treated with canagliflozin
- 2.8 out of every 1,000 patients treated with placebo
The CANVAS-R trial showed that over a year’s time, the risk of amputation for patients in the trial were equivalent to:
- 7.5 out of every 1,000 patients treated with canagliflozin
- 4.2 out of every 1,000 patients treated with placebo
Amputations of the toe and middle of the foot were the most common; however, amputations involving the leg, below and above the knee, also occurred. Some patients had more than one amputation, some involving both limbs.
Report side effects involving canagliflozin and other medicines to the FDA MedWatch program at fda.gov/medwatch.
A link to the full communication detailing specific information for health care professionals and the complete Data Summary can be found at fda.gov/DrugSafetyCommunications. If you have drug questions, you can reach us at email@example.com.
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- FDA Drug Safety Communication: FDA confirms increased risk of leg and foot amputations with the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR)
- FDA Drug Safety Podcast: FDA confirms increased risk of leg and foot amputations with the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR)