Risk of leg and foot amputations under Canagliflozin (Invokana, Invokamet)

May 17, 2017 – Following up on an earlier Drug Safety Communication from May 2016 and based on new data from two large clinical trials, the American Food & Drug Administration (FDA) has concluded that the type 2 diabetes medicines Canagliflozin (Invokana), Canagliflozin/Metformin (Invokamet),  and Canagliflozin/Metformin (Invokamet XR) cause an increased risk of leg and foot amputations. Consequently, FDA is requiring new warnings, including the most prominent Boxed Warning, to be added to the drug labels of all Canagliflozin-containing drug labels to describe this risk (see this new Drug Safety Communication here).

Final results from two clinical trials, a) the CANVAS (Canagliflozin Cardiovascular Assessment Study) and b) the 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 about twice as often in patients treated with Canagliflozin-containing medicines compared to patients treated with placebo, which is an inactive treatment. 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.
Canagliflozin (Invokana), Canagliflozin/Metformin (Invokamet), and Canagliflozin/Metformin (Invokamet XR) are prescription medicines used with diet and exercise to lower blood sugar in adults with type 2 diabetes. Canagliflozin belong to a class of pharmaceutically active compounds called sodium-glucose cotransporter-2 (SGLT2) inhibitors. Canagliflozin lowers blood sugar by causing the kidneys to remove sugar from the body through the urine.
Patients taking Canagliflozin-containing medicines should notify their health care professionals right away if they develop new pain or tenderness, sores or ulcers, or infections in their legs or feet. They should talk to their health care professional if they have questions or concerns. Patients should not stop taking their diabetes medicine without first talking to their health care professional.
Health care professionals should, before starting canagliflozin, consider factors that may predispose patients to the need for amputations. These factors include a history of prior amputation, peripheral vascular disease, neuropathy, and diabetic foot ulcers. Monitor patients receiving canagliflozin for the signs and symptoms described above and discontinue canagliflozin if these complications occur. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Programm by completing  and submitting the report online at www.fda.gov/MedWatch/report or by downloading the form or calling  001-800-332-1088 to request a reporting form, then completing and returning to the address on the pre-addressed form, or submitting by fax to 001-800-FDA-0178.
 
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thassodotcom

Ph.D.; Professor in Pharmacology and Toxicology. Senior expert in theragenomic and personalized medicine and individualized drug safety. Senior expert in pharmaco- and toxicogenetics. Senior expert in human safety of drugs, chemicals, environmental pollutants, and dietary ingredients.

Posted in Adverse Drug Reaction [ADR], New Safety Information, Regulatory Announcement, Thasso Post, Theragenomic Medicine
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