European Registry Data Shows High Chance of Jardiance Amputation Risk

European registry data has revealed that diabetes patients taking certain drugs may face a Jardiance amputation risk. Ketoacidosis and amputation are two of the most common and serious problems associated with taking these kinds of medications. These drugs are known as SGLT2 inhibitors.

Even though SGLT2 inhibitors are used commonly for the treatment of type-2 diabetes, patients might not have realized they may come with a higher risk of both amputation and ketoacidosis. SGLT2 diabetes drugs like Jardiance can lead to a twice-higher risk of lower limb amputation, studies report. Patients with diabetes already have a higher chance of a limb being amputated.

What Are SGLT2 Inhibitors?

The abbreviation “SGLT” stands for “Sodium Glucose co-Transporter.” This is a specific protein found in the kidney and plays an important role in the reabsorption of blood sugar, or glucose. Normally, the kidneys re-release this excess blood sugar into the bloodstream as it is needed. However, type-2 diabetics suffering from insulin resistance (a condition in which the body’s cells no longer respond properly to insulin) are unable to metabolize this glucose.

SGLT inhibitors such as Jardiance disables the mechanism that allows the kidneys to absorb excess glucose. Instead, it is passed out of the body through urination, helping the patient to maintain a normal blood sugar level.

When the first drug of this class was introduced in January of 2013, it was touted by the drugmaker as a medical miracle. However, according to a Frontline report, some prominent physicians, including consumer activist Dr. Sidney Wolfe, expressed serious concerns about whether or not Jaridance had been thoroughly tested for safety. At the time, Wolfe argued that the drugmaker’s claims of efficacy were based solely on the medicine’s effect on a patient’s hemoglobin A1C levels, which are only one indicator of how well glucose levels are being managed.

Despite physicians’ doubts, the FDA went ahead and approved the new medication on the condition that the manufacturer would conduct “post-marketing surveillance” and be aware of any potential problems. Since that time, SGLT2 inhibitors have been implicated in numerous serious side effects, including diabetic ketoacidosis, kidney disease, urogenital infections, and even gangrene.

What Scientific Research Showed

The European study, known as CANVAS, was a major cardiovascular research project exploring the outcomes for SGLT2 inhibitors. These results were published in BMJ in November 2018 and pointed out that toe or metatarsal amputations were the most common.

The Jardiance amputation risk had already been noticed by some patients who went through the loss of a toe or foot. Case reports are filed directly with the FDA when a patient experiences problems.

More Dangerous Side Effects

Outside of problems with the Jardiance amputation risk, patients have also reported issues with acute kidney injury, urinary tract infections, and diabetic ketoacidosis. Furthermore, although more research is pending, there are also some possible issues with acute pancreatitis.

In order to determine the connection between side effects and the drug itself, the CANVAS study looked at registry data drawn from Danish and Swedish databases. They looked at more than 21,000 people who were new to using the SGLT2 inhibitors and over 27,000 users of receptor agonists.

Of those who were using an SGLT2 inhibitor drug, a total of 98 percent of those patients were using Jardiance or Farxiga. In addition to the study showing that 2.7 lower limb amputations occurred for every 1,000 patient-years of treatment, the study found that patients using SGLT2 inhibitors were much more likely to receive a diagnosis of diabetic ketoacidosis.

In general, even though the risk of having a limb amputated was quite small, the impact of an amputation can be severe and life-changing. The study researchers stated that preventative foot care was important for patients taking these drugs. Smoking cessation and increased physical activity were found to help with the reduced risk of amputation to begin with.

Did the Drug Manufacturers Know?

Some patients who had to go through lower limb amputations argue that these risks were not adequately represented on the warning labels of the drugs, meaning that patients were not able to make an informed decision about taking the drug at all.

The European Medicines Agency had previously pushed for getting more of these amputation warnings posted on the drug’s label. That agency had launched their own investigation into whether SGLT2 drugs were associated with higher chances of an amputation.

Increasingly, other studies have indicated that patients who already face the risk of amputation due to their diabetes diagnosis and other factors should be aware of the dangers of losing a toe or foot just for taking their drugs to treat their condition.