New Report Warns of Increasing SGLT2 & Invokana Risks

Thursday, August 4, 2016
Invokana Diabetes

A new class of diabetes drugs known as SGLT2 inhibitors has seen tremendous growth over the past few years. However, a leading consumer safety organization recently issued a troubling report uncovering a multitude of side effect concerns.

SGLT2 inhibitors are prescribed to patients with type 2 diabetes. They essentially make the kidneys excrete blood sugar and sodium instead of absorbing them.

The first SGLT2 drug introduced in 2013, and still the most prescribed, is Invokana. In just a few short years, it has grown by 600% to over 5 million prescriptions each year.

Last month, the Institute for Safe Medication Practices (ISMP) reported on a growing trend of SGLT2 and Invokana side effect complaints that patients should be aware of before switching to these new drugs.


Studies Uncover Dangerous Invokana Side Effects

At the time Invokana was approved by the FDA, only short-term studies were available to measure its potential side effects. Therefore, the agency ordered a long-term study of cardiovascular risks called the CANVAS study.

Although the CANVAS study isn’t due to be completed until 2017, the data received so far has shown patients using Invokana have an increased risk of bone fracture as well as foot and toe amputations.

Since the majority of patients taking Invokana are over the age of 65 and prone to falling, the risk of bone weakness and fracture is especially dangerous.


FDA Reports Show Invokana Ketoacidosis and Kidney Risks

The ISMP also reported on the growing number of Adverse Event reports to the FDA for ketoacidosis, kidney damage and infections among patients taking Invokana.

In 2015, the FDA received over 10,000 adverse event complaints for the three SGLT2 drugs Invokana, Farxiga and Jardiance. More than 10% of these were for ketoacidosis, a dangerous blood condition of high acid levels. Over 23% of complaints had to do with infections.

The agency also received a significant number of complaints that patients suffered kidney failure or damage while using Invokana, Farxiga or Jardiance.

So far, according to the ISMP, the FDA has issued five safety warnings so far for serious health risks associated with SGLT2 drugs in just over two years since they were released to the market.


Lawsuits for Ketoacidosis and Kidney Damage

DrugNews has discovered that, like the complaints to the FDA, the number of lawsuits linked to Invokana side effects is growing as well.

In both the United States and Canada, victims have started litigation against Janssen Pharmaceuticals for kidney damage and ketoacidosis. Due to the growing number of Invokana cases, lawyers are trying to consolidate them into a central multidistrict litigation court for faster handling.

For more information, or to speak with a lawyer about an Invokana lawsuit, contact DrugNews today.



QuarterWatch Annual Report. Dangerous Gamble with a New Class of Diabetes Drugs. ISMP. (June 29, 2016). Retrieved from



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