FDA Warns of Amputation Risk With Antidiabetic Agent

FDA warns of foot, leg amputations with J&J diabetes drug

It belongs to a class of drugs called sodium-glucose cotransporter-2 inhibitors. Excessive urination can potentially cause dehydration and blood volume depletion in high-risk patients that exacerbates circulatory problems.

Data from 2 large clinical trials have confirmed that treatment of type 2 diabetes with canagliflozin (Invokana®, Invokamet®, and Invokamet XR®; Janssen Pharmaceuticals, Inc.) may lead to an increased risk of leg and foot amputations, according to a US Food and Drug Administration (FDA) Drug Safety Communication.

The FDA's decision follows a MedWatch safety alert from this time a year ago, which regulators issued after finding that patients in the Invokana arms of J&J's two cardiovascular outcomes studies for the med were about twice as likely to experience amputations than were those in the placebo groups. The agency is requiring new warnings, including a prominent "boxed warning", to be added to the canagliflozin drug labels to describe this risk. Canagliflozin lowers blood sugar by causing the kidneys to remove sugar from the body through the urine.

Most of the amputations were of toes or the middle of the foot, but some patients needed their entire foot or leg removed, sometimes even above the knee.

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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. Before initiating canagliflozin therapy, health care professionals should consider factors that may predispose patients to the need for amputations, including a history of prior amputation, peripheral vascular disease, neuropathy and diabetic foot ulcers. Health care professionals are also urged to monitor patients who receive the drug for signs and symptoms and to discontinue the drug if complications occur.

People with diabetes are already at risk of having lower limbs amputated because of circulatory and nerve damage that the disease does over time.

A number of patients had to undergo more than one amputation, and some of those involved both limbs.

The study was focused on determining how canagliflozin affected the renal endpoints in adults with type 2 diabetes. Healthcare professionals and patients can report adverse effects related to canagliflozin and other medicines to the FDA MedWatch program.

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