Michael Phelan and Jonathan Petty | Virginia Trial Attorneys

INVOKANA: the risks keep growing

Invokana belongs to a newer class of Type 2 diabetes drugs called sodium-glucose cotransporter 2 (SGLT2) inhibitors . Instead of metabolizing blood sugar, which is how insulin and other Type-2 diabetes drugs work, Invokana, by design, stops glucose from being reabsorbed into the blood and converted into an energy source that the body can use. Instead, it causes the blood sugar to be pushed through the kidneys and urinated out. The first warnings concerning Invokana were that it can cause diabetic ketoacidosis, a condition that requires hospitalization and can cause fatal swelling of the brain, severe dehydration and coma. In 2016, warnings included kidney failure. If the body does not get enough water to urinate out all of the blood sugar, the body will extricate water from its own cells and fluid volume depletion occurs. When kidneys are depleted of fluid they go into failure. In essence, Invokana can cause the body to cannibalize itself.

The FDA approved Invokana based only on small sample short-term studies. The drug was launched in 2013. The warnings did not end with ketoacidosis and kidney failure, to wit:
* May 2015 – Diabetic Ketoacidosis (DKA) – DKA occurs when the body cannot use sugar (glucose) as a fuel source so it breaks
down fat for energy. This produces ketones that can build up in the body and become toxic.
* December 2015 – Blood Infection and Urinary Tract Infections (UTIs)
* June 2016 – Acute Kidney Injury (AKI) – AKI is where the kidneys suddenly stop working and allow waste to build up in the body
* August 2016 – beefed up Ketoacidosis warning (will die if not treated)
* February 2017 – Uroacidosis
* May 2017 – Leg and foot amputation

The FDA also required J&J to conduct post-marketing studies and a clinical trial after data showed an increase in the risk of cardiovascular problems such as stroke, blood clots and heart attacks. The results of the clinical trial are expected to be published this summer. In 2016, the FDA also received reports of acute pancreatitis in patients taking Invokana and other SGLT2 inhibitors.

Earlier this week, the FDA forced the manufacturers of Invokana to include a label warning that patients using Invokana are at a higher risk of leg and foot amputation. According to Forbes, Invokana was once seen as a breakthrough treatment for diabetes 2 as first in the class of SGLT2 inhibitors. Johnson & Johnson’s sales of Invokana already took a dip in the first quarter of 2017, and the addition of the black box warning about Invokana leg and foot amputations won’t help. A Drug Safety Communication from the FDA warns that Invokana doubles a patient’s chances of needing leg or foot amputations. The warning is based on two large clinical trials of Invokana.

You should notify your doctor right away if you are taking Invokana and develop new pain, tenderness, sores, ulcers or infections in your legs or feet. You should also not stop taking your diabetes medicine without first talking to your doctor.

If you or a loved one has been injured by Invokana, please contact Phelan Petty for a free, confidential consultation. You may call us toll free at 866-249-3164 or at 804-980-7100, or request a consultation by clicking on our Contact Form, which will be reviewed by one of our Invokana attorneys.