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Are Doctors Taking Diabetic Patients Off Invokana After Latest FDA Warning?

diabetes-2058045_1920-300x173A new research article asks if physicians are starting to move patients away from Invokana use? It’s a good question. On this blog, I’ve written about Invokana numerous times. For a detailed history of the drug, you can read some of my past articles which are cited at the end of this post.

What is Invokana? The drug is in a class of medications known as sodium-glucose cotransporter 2 (SGLT2) inhibitors. Other drugs in this class include Farxiga, Jardiance, Glyxambi, and Xigduo XR. SGLT2 inhibitors work by altering kidney function to stop reabsorption of glucose into the blood stream.

Diabetes is a huge health problem in the United States. Here, in Alabama, we suffer one of the highest rates of diabetes. Diabetic patients need good medical care. What they do not need are pills that carry more risk than benefit. While we need medications, we need those medications to be tested and safe for use. That’s why the growing list of serious injuries associated with Invokana is an important issue to Alabama patients (and a frequent topic of this blog).

What potential injuries have been linked to the drug? Diabetic Ketoacidosis. Kidney Damage. Bone Fractures. Foot and Leg Amputations. Keep in mind, the FDA only approved Invokana in March 2013. After approval, Invokana sales exploded. Drug maker Johnson & Johnson has earned huge profits from Invokana and the related drug Invokamet. While Johnson & Johnson’s drug sales exploded, so did the avalanche of potential injuries and adverse events.

In June 2016, the FDA required new Invokana labels warning about the risk of kidney damage. According to the June 2016 FDA communication:

The U.S. Food and Drug Administration (FDA) has strengthened the existing warning about the risk of acute kidney injury for the type 2 diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR). Based on recent reports, we have revised the warnings in the drug labels to include information about acute kidney injury and added recommendations to minimize this risk.

In May 2017, the FDA issued a new and very serious warning about the risk of foot and leg amputations from Invokana use. According to this FDA alert:

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.

This new article discussing reduced Invokana prescription trends is titled, Some Physicians Switch Patients Off Invokana After FDA Warning. According to the author:

Some physicians and their hospital-affiliated medical groups are scurrying to take patients off of the diabetes drug canagliflozin (Invokana), after results from CANVAS, the big FDA-mandated cardiovascular outcomes trial, found it doubled the risk of lower limb amputations compared with placebo .  .  .

While some healthcare providers continue to regularly prescribe Invokana, the new article discusses several well-known groups that have taken action to reduce or end its use. The article cites Kaiser Permanente in California:

In California statewide, Kaiser Permanente had few patients among its 8.5 million enrollees taking canagliflozin, but it sent its doctors names of patients who received the drug for closer monitoring. Kaiser also suggested they discontinue the drug for patients with certain conditions, such as foot ulcers.

The article also cites Dr. Steven Nissen, Chairman of Cardiovascular Medicine at the Cleveland Clinic. The article quotes Nissen as saying he is now “uncomfortable prescribing [Invokana] in view of the amputation risk.”

At the Blackwell Law Firm, we have followed Invokana and the growing health concerns involving the drug. You can follow the drug’s history since market approval by reading our prior posts. They are:

If you or a family member may have suffered personal injury following Invokana use, we are available to answer your questions. We specialize in personal injury claims. Consultations are always free and confidential.