Trials find the drug doubles the risk of leg and foot amputation
In a recent communication, the U.S. Food and Drug Administration (FDA) warned patients that taking the type 2 diabetes drug canagliflozin (Invokana, Invokamet, Invokamet XR) can cause an increased risk of leg and foot amputations. The FDA says patients taking Invokana and similar drugs should notify their doctor as soon as possible if they find new pain and tenderness in their feet and legs.
Invokana and Invokamet are part of a newer class of type 2 diabetes drugs called SGLT-2 inhibitors. These drugs work by decreasing the reabsorption of glucose by the kidneys, causing those taking the drug to excrete more of the sugar that they consume. Janssen Pharmaceuticals (a division of Johnson & Johnson) says that taking this drug will lower blood sugar and A1C levels in those that have diabetes.
The FDA’s amputation risk finding is based on two large clinical trials that compared outcomes in patients taking Invokana and those taking placebo. The studies found that patients taking Invokana were twice as likely to need amputations of the feet and legs. While most patients only needed amputations of toes, some patients required amputations above the knee. A small number of patients taking the diabetes drug needed multiple amputations involving both legs.
The FDA is now requiring manufacturers of Invokana and Invokamet to place a warning about amputations on the box of the drug. The so-called “black box warning” is reserved for drugs that the FDA deems carry the risk of serious or life-threatening side effects.
This is not the first time that the FDA has revised the label for Invokana. In December 2015, the FDA warned patients that taking the diabetes drug could cause ketoacidosis, a condition where the body fails to regulate ketone production, causing the blood to become acidic. Diabetic ketoacidosis can cause vomiting, pain, weakness and confusion and, if left untreated, can be fatal.
Some patients taking Invokana or Invokamet have filed lawsuits against Johnson & Johnson, claiming that they might have taken another drug had they known about the severity of the side effects.
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