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Frederick Owens
May 18, 2017

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.

Due to these results, the FDA will require new warnings on Invokana, including the attention-getting boxed warning.

Final results from two clinical trials - 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) - showed that leg and foot amputations occurred about twice as often in patients treated with canagliflozin compared with patients treated with placebo. However, amputations of the leg, below and above the knee, also occurred, and some patients had more than 1 amputation.

The Division of Drug Information (DDI)- serving the public by providing information on human drug products and drug product regulation by FDA. Invokana and Jardiance belong to a class of drugs called SGLT2 inhibitors. 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. 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.

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The CANVAS-R trial found the amputation risk was equivalent to 7.5 out of every 1,000 Invokana patients compared to 4.2 out of every 100 placebo patients.

J&J's Janssen subsidiary began the Canvas trial in December 2009 to examine the potential cardiovascular benefit of Invokana. Researchers examined benefits of Invokana on the kidneys.

People with diabetes are already at risk of having lower limbs amputated because of circulatory and nerve damage that the disease does over time. Jardiance was the first Type 2 diabetes drug to get approval for cutting the risk of cardiovascular death.

Still, the entire SGLT2 needs to grow for Jardiance to meet or beat forecasts.

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