Articles Tagged with Invokana

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INVOKANA USE MAY LEAD TO FOOT AND LEG AMPUTATIONS

On May 16, the Food and Drug Administration (FDA) issued a new warning about the diabetes drug Invokana. Now, the FDA “has concluded” based on tests that the drug presents an increased risk of foot and leg amputations. Specifically, the FDA safety alert says:

Based on new data from two large clinical trials, the FDA has concluded that the type 2 diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) causes an increased risk of leg and foot amputations. FDA is requiring new warnings, including the most prominent Boxed Warning, to be added to the canagliflozin drug labels to describe this risk.

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Our office has closely followed developments related to the diabetes drug Invokana. For more details on the medication and how it works, you can read a report under the Hot Topics section of our firm website. As we discuss on our website, Invokana is a relatively new diabetes drug manufactured by Johnson & Johnson. Yet, in just a few years on the market, the FDA has issued numerous safety communications about the drug.

  • Diabetic ketoacidosis.
  • Kidney damage.
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Our office has closely followed developments with the diabetes drug Invokana. Invokana is in a class of drugs known as sodium-glucose cotransporter 2 (SGLT2) inhibitors. This is a relatively new class of drugs also including Farxiga, Jardiance, Glyxambi, and Xigduo XR. These drugs treat diabetes by altering kidney function to stop reabsorption of glucose into the patient’s blood stream. We have a page on our firm website discussing these drugs, how they work and their link to diabetic ketoacidosis. Despite being a new drug at the time we published our initial page, Invokana had already been linked to numerous adverse health reports. Since then, even more potential injury risks have emerged. You can read about these developments in several posts on this blog.

In its recent QuarterWatch report, the Institute for Safe Medication Practices (ISMP) calls Invokana a “dangerous gamble.” The ISMP report opens with the following paragraph:

The nation’s gamble in embracing new drugs for long-term use with only short-term clinical testing was most apparent in the rapid acceptance into clinical practice of a new class of oral diabetes drugs called sodium-glucose cotransporter-2 (SGLT2) inhibitors. There are now three such agents, canagliflozin (INVOKANA), dapagliflozin (FARXIGA), and empagliflozin (JARDIANCE). Since approval, evidence of multiple safety problems has emerged.