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Invokana Toe Amputation Risk Under Review by EMA

Invokana Toe Amputation Risk Under Review by EMA

April 26, 2016 — European health regulators are asking Johnson & Johnson for more data after an ongoing clinical trial found a possible increased risk of toe amputations from the diabetes drug Invokana.

The European Medicines Agency (EMA) could recommend changes to the way Invokana is prescribed in the European Union if an increased risk of amputation is confirmed, according to MedscapeThe risk was seen in preliminary data from CANVAS, a long-term clinical trial comparing Invokana to a placebo in reducing cardiovascular (heart and blood vessel) disease.

The EMA estimates that 7 in 1,000 patients who take Invokana 100-mg for one year will experience a toe amputation, compared to 5 in 1,000 who take 300-mg doses and 3 in 1,000 who take a placebo.

CANVAS has enrolled 4,330 patients who were randomly assigned to take Invokana (100-mg or 300-mg) or a placebo every day. Researchers have tracked outcomes for an average of 4.5 years. The study should be completed in one year.

Type-2 diabetes is a risk-factor for foot complications, including amputations in the lower leg and toes. Poor blood-flow increases the risk of ulceration in the feet. These injuries tend to heal slowly and become infected, which can result in toe amputations. The EMA has sent a letter to doctors to remind them about the importance of treating foot injuries promptly and taking care to avoid cuts or sore that could lead to amputation.

Invokana is the first SGLT2 inhibitor and it has been on the market since 2013. It is one of the newest diabetes medications, but it has already been linked to a number of severe side effectsketoacidosis, severe urinary infections, kidney failure, bone fractures, and more.

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