Invokana has garnered considerable attention in the U.S. for safety issues, and the diabetes drug is now facing new scrutiny after a large industry-sponsored review found that it doubled the risk of lower limb amputations.
The study also found a small increase in diabetic ketoacidosis associated with Invokana use. Ketoacidosis is a serious and potentially fatal complication of diabetes that occurs when the body produces high levels of blood acids known as ketones, and is unable to produce enough insulin.
Link Between Invokana and Increased Amputations?
According to Medscape, the Pharmacovigilance Risk Assessment Committee (PRAC) has asked Johnson & Johnson’s Janssen unit for additional information about whether Invokana (canagliflozin) prompted an increase in toe amputations, and whether there should be modifications to the way the drug is used in the EU. The PRAC also requested data on other medications in the SGLT2 inhibitor class, including dapagliflozin and empagliflozin.
In May, the U.S. Food and Drug Administration (FDA) confirmed an increased risk of leg and foot amputations associated with canagliflozin, strengthened the warning on the drug’s label about an increased risk of bone fractures, and revised the “Adverse Reactions” portions of the Invokana and Invokamet labels. According to the FDA, patients with diabetes, particularly those whose condition is poorly controlled, are at an increased risk of infection and ulceration, which may lead to lower-limb amputations.
What is Invokana?
The FDA approved Invokana in March of 2013 as the first drug in a new class of oral agents to lower blood sugar in patients with Type 2 diabetes. Invokana, which is marketed by Janssen Pharmaceuticals, works by hindering the normal function of the kidney, which is to return any glucose to the blood while excreting waste products. Instead, Invokana causes substantial amounts of sugar to be excreted in the urine.