Invokana Manufacturers Seek New FDA Heart Indication for Controversial Diabetes Drug

Although a growing number of Invokana lawsuits continue to be filed against Johnson & Johnson’s Janssen subsidiary, alleging that inadequate warnings were provided about serious and potentially life-threatening injuries linked to the new-generation diabetes medication, the drug makers are asking federal regulators to approve use of Invokana for the prevention of heart problems.

In a press release issued on October 2, Janssen announced that is seeking a new FDA indication for Invokana to be marketed as a method of reducing the risk of major heart problems.

Invokana (canagliflozin) is part of a controversial 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 since it hit the market in March 2013.

The application for the new indication, if approved, would allow the company to market Invokana, Invokana XR and Invokamet as a prophylactic for heart attacks, stroke, and cardiovascular death among adults with type 2 diabetes. While doctors may prescribe drugs for any reason they wish, it is illegal for drug manufacturers to market their products for reasons not approved by the FDA.

The request comes following recent findings from a clinical trial known as CANVAS, which was published this summer and suggested that Invokana could be beneficial for the prevention of heart problems in type 2 diabetics. However, the same study highlighted a serious amputation problems with Invokana, and the medication has been linked to a steady stream of new health concerns as more diabetics switch to the treatment.

The CANVAS study found an increased risk of amputation among Invokana users, with 6.3 amputations per 1,000 patient years, compared to 3.4 among those given the placebo. Those researchers calculated that Invokana use increased the risk of amputations by 97%.

Following a review of the data earlier this year, the FDA required a warning label update in May 2017, adding information about the potential Invokana amputation risks. Information about an increased incidence of leg, foot and toe amputations seen in the study was placed in a prominent black box on the label, which is one of the strongest warnings the agency can require a prescription medication to carry.

Those warnings come following a prior label update in December 2015, where the FDA required diabetic ketoacidosis warnings for Invokana and other SGLT2 inhibitors, indicating for the first time that users may face of risk of developing this serious condition. Prior 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, which is critical for avoiding serious complications from diabetic ketoacidosis.

Concerns about a potential link between Invokana and kidney failure have also emerged since the drug hit the market. In June 2016, the FDA required that new information be added to the drug label about the risk of acute kidney injury and other kidney issues.

Invokana Litigation

According to allegations raised in hundreds of product liability lawsuits filed nationwide against Johnson & Johnson and it’s Janssen subsidiary, the drug makers have placed their desire for profits before consumer safety by continuing to push wider use of the medication without adequately researching the potential side effects of Invokana, or warning about health risks the drug makers knew or should have known about.

Given similar questions of fact and law raised in lawsuits filed throughout the federal court system, the Invokana litigation has been centralized before U.S. District Judge Brian Martinotti in the District of New York for coordinated discovery and pretrial proceedings.

Known as a federal MDL, or multidistrict litigation, it is expected that Judge Martinotti will schedule a series of early “bellwether” trials involving each of the injury categories over the next few years.

While the outcomes of these early trials are not binding on other plaintiffs, they are designed to help the parties gauge the strengths of their evidence and facilitate potential Invokana settlements, without the need for hundreds of individual trials to be scheduled in U.S. District Courts nationwide.