After a full year of investigation, the U.S. Food and Drug Administration asked Tuesday Johnson & Johnson to add warnings to its diabetes drug, Invokana, about the risk of foot and leg amputations. A similar requirement was previously introduced for Invokana by the European Medicines Agency (EMA).
In addition to Invokana, the warning applies to dapagliflozin (Farxiga and Xigduo) and empagliflozin (Jardiance and Glyxambi).It was not yet clear why and how canagliflozin (which belongs to a class of drugs called SGLT2 Inhibitors) increases amputation risks. INVOKANA® is a once-daily pill that works around the clock lowering blood sugar in adults living with type 2 diabetes. Using it. although it’s not a blood pressure medicine, you may see lower systolic blood pressure. It may also help to weight loss on average of 3 percent. The drug is recommended by the American Diabetes Association. However, safety warnings until now enumerated important side effects, including dehydration, vaginal or penis yeast infection, ketoacidosis, urinary tract infections, serious allergic reactions and hypoglycemia.
The actual new warning imposed is the most important and dangerous and resulted from trials.In fact, over a year’s time, 7 out of every 1,000 patients on 100 mg of Invokana and 5 out of every 1,000 patients on 300 mg of Invokana had a risk of amputation. This is not a good thing !