Invokana Poses 2X Leg, Foot Amputation Risk: FDA Black Box Warning

Invokana Poses 2X Leg, Foot Amputation Risk: FDA Black Box Warning

Consumers who are taking canagliflozin to treat their type 2 diabetes are being warned that the drug carries an increased risk of leg and foot amputations.

The FDA included a new boxed warning to the label of canagliflozin (Invokana, Invokamet, Janssen) to describe the risk for leg and foot amputations. The new warning is based on recent data from 2 clinical trials, CANVAS (Canagliflozin Cardiovascular Assessment Study) and CANVAS-R, that demonstrated an increased risk of leg and foot amputation, mostly affecting toes.

Some Invokana patients suffered more than one amputation, with a portion of those patients needing amputations on both limbs.

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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. This warning is an update to the safety communication issued on May 18, 2016. It belongs to a class of drugs called sodium-glucose cotransporter-2 (SGLT2) inhibitors. Canagliflozin is available through prescription as a single-ingredient drug, or in combination with metformin, sold as Invokamet. It will alert patients to be watchful and notify health care providers about ulcers, infections, or any new pain or tenderness in their legs and feet. Talk to your health care professional if you have questions or concerns. It lowers blood sugar by causing the kidneys to remove sugar from the body through the urine. Do not stop taking your diabetes medicine without first talking to your health care professional. If left untreated, type 2 diabetes can lead to kidney damage, heart disease, and blindness.

Before prescribing canagliflozin, according to the FDA's advice, healthcare professionals should consider factors that might predispose patients to amputations, including a history of prior amputation, peripheral vascular disease, neuropathy, and diabetic foot ulcers. However, in two clinical trials of the drug canagliflozin, marketed as Invokana, Invokamet, and Invokamet XR, patients taking the drug were twice as likely to need amputations.

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

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