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Peter J. Brodhead | Mar 15, 2015

Clinical Trial Data Links Invokana With Kidney Failure

Categories: Invokana

Invokana, a drug approved by the FDA in March 2013 for the treatment of Type 2 diabetes, has been associated with kidney failure and cardiovascular injuries as well as other serious, adverse health issues. In a Phase 3 Clinical Trial Program implemented by the manufacturer of Invokana, Janssen Pharmaceuticals, there were issues associated with impaired renal function. The clinical trial noted that Invokana (canagliflozin) increases serum creatinine, while decreasing eGFR. Patients with hypovolemia—a decreased volume of circulating blood in the body—are likely more susceptible to the serum creatinine increases and the eGFR decreases.

Caution Warranted when Prescribing Invokana to the Elderly

The trial also concluded that renal function abnormalities can occur after patients begin taking Invokana, therefore frequent renal function monitoring is recommended for at-risk patients. Further, it appears the elderly are at a significantly higher risk of developing renal function abnormalities as well as Invokana side effects such as hypotension, dehydration, syncope and dizziness on standing. Invokana also raises the risk of hyperalkemia (high potassium levels), particularly in patients who take blood pressure medication. Hyperalkemia can, in turn, lead to heart rhythm abnormalities.

How Invokana Works

Invokana is a SGLT-2 (sodium-glucose co-transporter) inhibitor which lowers blood sugar levels in Type 2 diabetes patients. Invokana inhibits SGLT-2, a carrier which aids in the reabsorption of glucose into the bloodstream, via the kidneys. Invokana, unlike many older diabetic drugs, immediately attacks blood sugar, flushing the excess sugar out through the urine. Due to the way Invokana works in the kidneys, there was some concern at the time the drug received FDA approval regarding potential harm to those with kidney disease. Since kidney disease is relatively common among diabetics, Invokana could lead to additional harm to the kidneys.

Another Link between Invokana and Kidney Damage

In May 2015, the Institute for Safe Medication Practices discussed the possible correlation linking kidney damage and Invokana. Four hundred and fifty seven occurrences of kidney issues related to Invokana have been identified since the drug was approved in 2013. These reports included patients who developed kidney stones, dehydration, urinary tract infections, compromised kidney functioning and kidney failure while taking Invokana. These statistics led the ISMP to question whether the benefits of Invokana outweigh the risks.

FDA Warns Invokana Could Lead to Ketoacidosis and Kidney Failure

At the same time the ISMP released their report, the FDA issued their own warning regarding SGLT-2 inhibitor drugs. The agency warned that Invokana and other drugs like it could be responsible for ketoacidosis, a serious medical issue which can subsequently lead to diabetic coma, kidney failure and death. Ketoacidosis is a condition in which the body produces extreme levels of ketones (blood acids). When vomiting is present, ketoacidosis can be a life-threatening condition which develops over a few hours. Early symptoms of ketoacidosis include dry mouth, excessive thirst, frequent urination and high blood sugar levels.

Ketoacidosis Can Result in Kidney Failure

In a patient who has ketoacidosis from Invokana, kidney failure may also occur. Symptoms of kidney failure include:

· Diminished appetite,

· Nausea;

· Vomiting;

· Little urine output;

· Confusion;

· Restlessness;

· Unusual tiredness or sleepiness;

· Pain below the rib cage, and

· Swelling in the feet and legs.

Did Janssen and Johnson & Johnson Fail to Warn Consumers About Invokana Dangers?

The very core of product liability law is that products—including drugs and medical devices—must be reasonably safe for their intended purpose. A manufacturer can be held liable for a failure to provide adequate warnings if a consumer suffers injury due to the lack of such warning. In a failure to warn case the manufacturer must have been aware of the inherent dangers of the drug. In the case of Invokana, it would be hard to imagine J & J and Janssen were not aware of the dangers associated with the drug. This is particularly true when considering the manufacturers own clinical trials, as well as the more than 450 adverse event reports sent to the FDA during Invokana’s first year on the market.