FDA issues Boxed Warning for canagliflozin

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Clinical trials have shown several cases of leg and foot amputations in type 2 diabetes patients who were treated with the drug Invokana, as against to those who were given a placebo. As a result, the FDA is requiring new warnings, including a Boxed Warning, to be added to canagliflozin and canagliflozin-containing drug labels to address this risk. "Some patients had more than one amputation, some involving both limbs", said the FDA.

The FDA encourages health care professionals and patients to report adverse events or side effects related to the use of canagliflozin to the FDA's MedWatch Safety Information and Adverse Event Reporting Program at www.fda.gov/MedWatch/report or 800-332-1088 to request a reporting form.

Canagliflozin is available as a single-ingredient drug as well as in combination with metformin. Talk to your health care professional if you have questions or concerns.

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Invokana is part of a class of diabetes drugs known as SGLT-2 inhibitors, which cause the kidneys to remove sugar from the body through urine and thereby lower blood sugar levels in patients with diabetes. Do not stop taking your diabetes medicine without first talking to your physician. After all, SGLT2 rival Jardiance from Eli Lilly and Boehringer Ingelheim has already showed it can cut the combined rate of heart attack, stroke and cardiovascular death in high-risk Type 2 patients, and J&J is crossing its fingers that its med can do the same in an upcoming trial. Patients taking canagliflozin should be monitored for signs and symptoms of those conditions, and the drug should be discontinued if such complications occur.

Patients taking canagliflozin should notify your health care professionals right away if you develop new pain or tenderness, sores or ulcers, or infections in your legs or feet. History of prior amputation, peripheral vascular disease, neuropathy, and diabetic foot ulcers are all factors that may put patients at an increased risk. It can cause hypotension, ketoacidosis, kidney problems, a large amount of potassium in the blood, urinary infections, high cholesterol, yeast infections, bone fractures, and low blood sugar if combined with other drugs for treating diabetes.

Canagliflozin is an antidiabetic medication used with diet and exercise to improve glycemic control in adults with type 2 diabetes.