Emily Sortor  |  July 19, 2020

Category: Diabetes

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diabetics face dangers of taking Invokana

Type-2 diabetics who have been prescribed Invokana (canagliflozin) or Invokamet may have heard about the dangers of taking Invokana, including amputations, ketoacidosis, urinary tract infections and more.

Initially hailed as a “miracle drug” for the treatment of type-2 diabetes, Invokana and other drugs of the gliflozin class have been linked to numerous serious side effects. Here, you will find answers to some important questions about this controversial medication.

What Are Gliflozin Drugs?

The gliflozin class of prescription medications, of which Invokana was the first to receive FDA approval, are also known as “SGLT2 inhibitors.” The initials stand for “sodium glucose transporter,” which is a protein that plays a key role in the reabsorption of glucose in the kidneys.

Invokana and other gliflozin drugs prevent this from happening; as a result, excess glucose is passed in the urine, resulting in lower blood sugar levels and better glycemic control.

These medications have also been found to help with weight loss and reduce blood pressure.

Why Does Invokana Increase Amputation Risk?

The exact mechanism by which taking Invokana raises a patient’s risk of lower limb amputations is not fully understood. However, an Invokana study presented in October of 2018 at the annual meeting of the European Association for the Study of Diabetes provides some clues.

The researchers found evidence to suggest connecting the use of Invokana with reduced blood flow to the lower extremities. Among the dangers of Invokana, this is especially serious for diabetics, many of whom already suffer from impaired circulation.

Dr. David Lam, assistant professor of medicine, endocrinology, diabetes and bone disease at the Icahn School of Medicine at Mount Sinai in New York City, said because SGLT2 inhibitors cause increased urination, the result could be dehydration. Any time the body becomes dehydrated, blood becomes thicker and does not circulate as well, and reduced circulation increases amputation risk.

To understand the possible dangers of taking Invokana, and to gain insight into why Invokana might increase a diabetes patient’s risk of amputation, it is important to understand the broader relationship between diabetes and amputation. Invokana aside, diabetes patients in general are at higher risk for amputation than those without diabetes. 

Nerve damage, or neuropathy, is one complication of diabetes. According to the Mayo Clinic, experts believe that uncontrolled diabetes can damage nerves over time. This can impair their ability to send signals to one another, which leads a patient with neuropathy to be less able to feel sensation in the affected area.

This means that if a diabetic patient with neuropathy injures a part of their body, their neuropathy might not allow them to feel pain and take steps to prevent further injury. To make matters worse, diabetes can decrease a patient’s ability to heal from wounds. As a result, if an injury does occur, it can quickly worsen, and may become infected.

If a wound is unable to heal and does become infected, amputation of the affected area may be required to prevent the infection from spreading to other parts of the patient’s body. 

Unfortunately, this is a serious issue for diabetes patient. Around 15 percent of people with diabetes will develop an ulcer at some point during their life. Once an ulcer develops, the prognosis is not positive. About 24 percent of people who get a foot ulcer will then need an amputation. Diabetic foot ulcers are the most common reason why a diabetic patient will be hospitalized, notes Health.com.

Is There an FDA Warning About the Risk of Amputations?

In May 2017, the FDA said two large clinical trials provided data that indicated Invokana caused an increased risk of leg and foot amputations. At that time, the FDA ordered its most prominent Boxed Warning be added to labels of Invokana, Invokamet and Invokamet XR regarding the risk.

Who Is Most at Risk of Amputations?

What are the dangers of taking Inovkana?Patients with diabetes who have peripheral vascular disease, neuropathy, diabetic foot ulcers or a history of a previous amputation are at a higher risk of another amputation. Patients are advised to pay attention to their legs and feet, and report to their health care provider the evidence of any new pain or tenderness, sores, ulcers or infection that could get out of control quickly.

Did the Drugmakers Know?

If Invokana’s manufacturers (Mitsubishi Tanabe and Janssen Pharmaceuticals) were unaware of the dangers of compromised blood flow, some patients argue they should not have been.

In 2013, just prior to Invokana being approved by the FDA, physician and consumer activist Dr. Sidney Wolfe pointed out that during the clinical trial, patients who took Invokana wound up with a significantly greater concentration of red blood cells, which in turn can lead to blood clotting and increased risk for stroke or heart attack – both of which result from a loss or blockage of blood flow.

Although this effect has been noted with other drugs of the gliflozin class, it was especially pronounced with Invokana. This would help to explain why the amputation dangers of taking Invokana are unique and not found among other SGLT2 inhibitors.

What Are Other Dangers of Taking Invokana?

In addition to elevated risk of lower limb amputations, other dangers of taking Invokana include:

  • acute pancreatitis
  • ketoacidosis (dangerously low blood pH levels)
  • kidney failure
  • osteoporosis
  • cardiovascular events (heart attacks and stroke)

I Was Affected – What Can I Do?

If you lost a lower limb or were otherwise injured after taking Invokana, you may have a legal claim against the drug’s manufacturers. Currently, there are approximately 900 lawsuits against Janssen Pharmaceuticals and its parent company, Johnson & Johnson, over the dangers of taking Invokana.

In October 2018, Johnson & Johnson reached an Invokana settlement with plaintiffs whose cases had been consolidated into multidistrict litigation before a federal court in New Jersey.

Contact an experienced Invokana attorney today to discuss your legal options if you or a loved one had to undergo a lower limb amputation after taking Invokana, Invokamet or Invokamet XR, including a toe amputation, foot amputation, knee amputation or leg amputation. Fill out the form on this page to obtain a FREE case evaluation with an Invokana amputation attorney.

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