FDA Adds Boxed Warning to Janssen's Type 2 Diabetes Drug Label

FDA Adds Boxed Warning to Janssen's Type 2 Diabetes Drug Label

Based on new data from two large clinical trials, the U.S. Food and Drug Administration (FDA) has concluded that the type 2 diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) causes an increased risk of leg and foot amputations.

Nearly exactly 1 year ago, the FDA issued an alert about interim results from the two trials that suggested the increased amputation risk, and promised an update when fuller data were available.

The new Boxed Warning, the strongest label the FDA can place on a prescription medication, will now inform patients about the risk of amputation from canagliflozin.

Canagliflozin is prescribed alongside diet and exercise to help patients with type 2 diabetes lower their blood sugar.

Lower-limb infections, gangrene, diabetic foot ulcers, and ischemia were the most common precipitating factors for amputations in the studies, the FDA said. It inhibits the sodium-glucose cotrasporter-2, and its effects are measured through the amount of sugar in the patient's urine, as the drug focuses its effects on the kidneys. The data showed that the incidence of leg and foot amputations occurred about twice as often in canagliflozin-treated patients vs. placebo patients. Healthcare professionals and patients can report adverse effects related to canagliflozin and other medicines to the FDA MedWatch program.

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Results showed that 5.9 out of every 1,000 patients treated with canagliflozin were amputated, compared to 2.8 out of every 1,000 patients treated with placebo who were also amputated.

A second trial showed the risk of amputation was equivalent to 7.5 out of every 1,000 patients treated with Invokana compared with 4.2 out of every 1,000 patients given a placebo.

RECOMMENDATION: 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.

Diabetic foot is a common problem in people with type-2 diabetes, a disease that causes chronic high-blood sugar levels. Patients with a baseline history of prior amputation, peripheral vascular disease, and neuropathy were found to be at greatest risk; clinicians should consider these risk factors prior to initiating treatment with canagliflozin.

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