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

A Johnson & Johnson building is shown in Irvine California U.S

Johnson & Johnson's type 2 diabetes medicine Invokana (canagliflozin) will now be required to carry a black box warning for an increased risk of foot and leg amputations, the Food and Drug Administration said Tuesday in a safety alert posted to its website.

The FDA will now require Johnson & Johnson to add a boxed warning to its Invokana/Invokamet labels.

The FDA's decision was based on new study data from the 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) trials.

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




Researchers also found that the risk of amputation in patients treated with Invokana in one year was equivalent to 5.9 out of every 1,000 patients as compared with 2.8 out of every 1,000 patients who were given a placebo. This warning is an update to the safety communication issued on May 18, 2016.

Invokana belongs to a relatively new class of type 2 diabetes drugs called SGLT-2 inhibitors, which help remove excess blood sugar through urine. Although it is usually sold under its commercial name Invokana, it is also combined with metformin in Invokamet and Invokamet XR.

Patients on canagliflozin are urged to notify their health care professional right away if they notice new pain or tenderness, sores or ulcers, or infections in their legs or feet. Talk to your health care professional if you have questions or concerns. These drugs block the reabsorption of glucose in the kidneys, increase glucose excretion and lower blood glucose levels.

The warning comes as last May, the European Medicines Agency (EMA), the UK's Medicines and Healthcare products Regulatory Agency and Janssen told health professionals of the increased risk. If left untreated, type 2 diabetes can lead to kidney damage, heart disease, and blindness. Patients taking canagliflozin should be monitored for signs and symptoms of those conditions, and the drug should be discontinued if such complications occur. 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.

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