European Officials Ask for Invokana Amputation Risk Data

April 26, 2016 — Johnson & Johnson’s diabetes drug Invokana is under investigation by European regulators after a clinical trial discovered a possible increased risk of toe amputations.

People with type-2 diabetes, especially those with pre-existing heart problems or uncontrolled blood-sugar, have an increased risk of infection and ulceration in the feet that can result in toe amputations.

The European Medicines Agency (EMA) started a review after an increase in amputations, mostly in the toes, was seen in an ongoing clinical trial called CANVAS.

CANVAS is a long-term study investigating whether Invokana reduces cardiovascular disease. It compares outcomes for patients on Invokana vs. a placebo. The study involves about 4,300 patients throughout Europe who have been tracked for an average of 4.5 years. The study should be completed next year.

The rate of lower-limb amputation in the study is currently 7 in 1,000 patient-years with Invokana 100-mg daily and 5 in 1,000 patient-years with Invokana 300-mg daily, compared with 3 in 1,000 patient-years with a placebo. One patient-year is equivalent to one patient taking the medicine for one year.

While the review is ongoing, European health officials have sent a letter to healthcare providers reminding them of the importance of routine foot care to avoid cuts or sores on the feet. Any injuries should be treated promptly to avoid complications like infection, ulceration, and amputation.

Medscape reports that regulators have asked drug-makers for more information about whether Invokana triggered a spike in lower-limb amputations. If so, regulators may recommend changes to the way Invokana is used in the European Union.

Invokana was the first member of a new class of diabetes drugs known as SGLT2 inhibitors. It has only been on the market since 2013, but is already associated with ketoacidosis, severe urinary infections, kidney problems, bone fractures, and other severe side effects.

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