Invokana Kidney Failure Adverse Event Reports Higher Than Similar Drugs: Study
Researchers indicate that a new class of diabetes drugs, which include Invokana, Farxiga, Jardiance and other blockbuster medications, are linked to a higher rate of acute kidney failure than other diabetes treatments, with Invokana kidney failure rates standing out in the class.
In a study published last month in the medical journal Nutrition, Metabolism and Cardiovascular Diseases, Israeli researchers evaluated the association between sodium-glucose contransporter-2 (SGLT-2) inhibitors and acute renal failure in the FDA adverse event reporting system.
The class of diabetes drug was introduced in March 2013, when Invokana (canagliflozin) was approved by the FDA. Since then, other SGLT-2 inhibitors have been approved, including Invokamet, Jardiance, Farxiga, Xigduo and others, but Invokana remains the most widely used.
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Among adverse event reports submitted to the FDA between January 2013 and September 2016, researchers indicate that Invokana and other SGLT-2 inhibitors were associated with an increase in the proportion of reports involving acute renal failure compared to other drugs.
Out of 3.8 million reports during that time period, nearly 19,000 were linked to SGLT-2 inhibitors. Of those reports, drugs like Invokana, Jardiance and Farxiga were associated with 1,224 cases of acute renal failure (ARF).
According to the findings, the proportion of reports involving acute renal failure were almost three times higher when SGLT-2 inhibitors were involved
Out of the members of the new class, Invokana kidney failure reports accounted for the highest proportion of events at 7.3%, compared to Jardiance at 4.7%, and Farxiga at 4.8%.
“SGLT-2 inhibitors are associated with an increase in the proportion of reports of ARF compared to other medications,” the researchers concluded. “SGLT-2-inhibitor agents may differ from one another in their respective risk for ARF.”
Invokana Side Effects
Although Invokana and other SGLT-2 inhibitors have been aggressively promoted as superior new diabetes treatments, a steady stream of new health risks have emerged as more users switched to the medications.
In December 2015, the FDA required new diabetic ketoacidosis warnings for Invokana and other SGLT-2 inhibitors, indicating that the medications increase the risk of this serious condition, which typically results in the need for emergency treatment to avoid life-threatening injury.
Prior to the update, the Invokana warnings failed to alert consumers about the importance of seeking immediate medical attention if they experience symptoms like abdominal pain, fatigue, nausea, respiratory problems or vomiting.
In June 2016, the FDA required additional label warnings about the link between Invokana and kidney risks, indicating that the medication may increase the risk of acute kidney injury and other severe health problems.
Most recently, in May 2017, the FDA required an Invokana warning update regarding the risk of leg and foot amputation, which manufacturers of other SGLT2 inhibitors claim is a unique risk with Invokana, not seen with their competing drugs.
The latest study comes amid a growing number of kidney failure lawsuits, as well as diabetic ketoacidosis lawsuits, heart attack lawsuits and amputation lawsuits filed against the drug makers in recent months, each raising similar allegations about label deficiencies.
Given the similar questions of fact and law raised in complaints filed throughout the federal court system, the Invokana litigation has been centralized before U.S. District Judge Brian Martinotti in the District of New Jersey for coordinated discovery and pretrial proceedings.
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