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Since Invokana was introduced as the first member of a new class of diabetes drugs, a steady stream of serious health concerns have emerged, including a risk of diabetic ketoacidosis, amputations and other injuries. However, a new study suggests that the medication may be better for the heart than other diabetes drugs from different classes, such as Byetta and Victoza.
In a study published this month in the medical journal The BMJ, researchers from Brigham and Women’s Hospital and Harvard Medical School indicate that Invokana appears to have a better cardiovascular safety profile than drugs known as DPP-4 inhibitors, GLP-1 receptor agonists or sulfonylureas.
Invokana (canagliflozin) was introduced in March 2013, as the first member of a new class of diabetes drugs, known as sodium-glucose cotransporter 2 (SGLT2) inhibitors, which works in a unique way by impacting some normal kidney functions. Other members of this class include Invokamet, Jardiance, Farxiga, Xigduo and others, but Invokana has remained the biggest seller, amid aggressive marketing.
This latest study only looked at Invokana, comparing heart outcomes to diabetes drugs from other classes, but did not compare it to drugs from the same class.
Researchers conducted a nationwide sample of patients with type 2 diabetes from a large U.S. commercial healthcare database. They looked at data on patients 18 years of age or older who took Invokana or a non-SGLT-2 inhibitor diabetes drug between April 2013 and September 2015. They then looked at rates of heart failures, heart attacks and strokes that resulted in hospitalization.
According to the findings, Invokana was linked to a lower risk for heart failure admission to a hospital compared to drugs from all of the other classes of diabetes medications. It had similar risks of other cardiovascular endpoints identified by the study.
“In this large cohort study, canagliflozin was associated with a lower risk of heart failure admission to hospital and with a similar risk of myocardial infarction or stroke in direct comparisons with three different classes of non-gliflozin diabetes treatment alternatives as used in routine care,” the researchers concluded. “Our study also suggests that the potential beneficial effect of canagliflozin with regard to heart failure admission to hospital tends to occur early, within the first six months after treatment initiation.”
The findings may be good news for Johnson & Johnson and it’s Janssen subsidiary, who manufacture the popular diabetes drug, and who have come under fire and face increasing litigation as more of the drug’s side effects have been revealed.
Invokana Side Effects
As more and more diabetics have switched to Invokana, a steady stream of post-marketing adverse event reports have led the FDA to require several warning label updates in recent years, adding information about potential side effects for consumers and doctors that was not initially disclosed by the drug maker.
In December 2015, the FDA required Johnson & Johnson to add new diabetic ketoacidosis warnings to Invokana, indicating that the medication increases 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.
More 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 manufacturers now face about 1,000 Invokana lawsuits pending in the federal court system, which each raise similar allegations that the medication was not adequately researched before it was introduced, and that important safety information was withheld and concealed.
Given common questions of fact and law, the cases are currently centralized before U.S. District Judge Brian R. Martinotti in New Jersey to reduce duplicative discovery into common issues, avoid conflicting pretrial rulings and to serve the convenience of the parties, witnesses and the judicial system.
As part of the coordinated pretrial proceedings in the federal multidistrict litigation (MDL), it is expected that a small group of “bellwether” cases will be prepared for early trial dates to help the parties gauge how juries may respond to certain evidence and testimony that will be repeated throughout the litigation.
Following any bellwether trials, if Invokana settlements or another resolution for the cases is not found, hundreds of claims may later be remanded to U.S. District Courts nationwide for separate trial dates.