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Spangenberg Shibley & Liber LLP | Sep 10, 2015

457 Serious Adverse Event Reports Related To Invokana And Other SGLT-2 Drugs

Categories: Invokana

When adverse event reports associated with the drug Invokana—and other similar drugs used to treat Type 2 diabetes—are examined, the reports suggest a broad range of serious side effects including diabetic ketoacidosis, kidney failure, kidney damage and heart problems. Invokana is an SGLT-2 inhibitor drug, in the same class as Farxiga, Invokamet, Jardiance, Xigduo XR and Glyxambi. In May 2015, the FDA warned of potential dangers associated with Invokana and the other five SGLT-2 inhibitor drugs, stating the medications could be responsible for the development of diabetic ketoacidosis. The FDA vowed to continue to investigate safety issues associated with the drugs to determine whether additional labeling changes are required.

Diabetic Ketoacidosis Linked to Invokana Use

Of the 457 adverse event reports, 23 were linked to patients taking Invokana who required either a trip to the emergency room or hospitalization to treat the very serious symptoms of diabetic ketoacidosis. Ketoacidosis can cause such serious complications as fluid buildup in the brain, death of bowel tissue, kidney failure and heart attack. In addition to ketoacidosis, new areas of concern were identified, including heart failure.

Did Janssen and J & J Conduct Sufficient Safety Trials for Invokana?

Johnson & Johnson was the first manufacturer to bring an SGLT-2 inhibitor drug to market, followed quickly by Farxiga, manufactured by AstraZeneca. Invokana enjoyed a rapid rise in sales, and has maintained a dominant position within the class of SGLT-2 inhibitor drugs. Unfortunately, as more people take Invokana, additional risks are surfacing which suggest Invokana may not have been thoroughly researched. Many are concerned about the lack of adequate labeling accompanying Invokana which warns patients of the potential risks.

At the same time the FDA issued its warning regarding SGLT-2 drugs, the Institute of Safe Medication Practices released a report which evaluated the adverse event reports submitted to the FDA. In this report, potential “safety signals” were identified regarding the toxicity of Invokana and other SGLT-2 drugs to the kidneys. There were also questions raised regarding whether the risks associated with Invokana outweighed the benefits provided by the drug. This, in turn, begs the question of why the FDA approved Invokana.

Generally speaking, FDA policy is to consider a drug safe if the risk/benefit ratio scales are tipped even slightly toward the benefits side. This means that while the FDA may have been aware of certain cardiovascular issues associated with Invokana, it is possible they made the determination that cardiovascular issues stemming from Type 2 diabetes created a greater safety hazard than cardiovascular issues associated with the drug.

Diabetic Ketoacidosis Injuries Could Be Higher Than Indicated by Adverse Event Reports

The reports of diabetic ketoacidosis brings a new concern. It is widely recognized that less than 10 percent of all those who suffer an adverse health issue associated with a drug or medical device will actually submit a report to the FDA. This means the 457 adverse event reports associated with Invokana are likely only a small percentage of the total problems associated with the drug. Despite this, the Institute of Safe Medication Practices found Invokana received more adverse event reports than 92 percent of other drugs the group routinely monitors.

Public Citizen Calls Invokana a “Do Not Use” Drug

Soon after Johnson & Johnson and Janssen began marketing Invokana, Public Citizen categorized the drug as a “do not use.” Public Citizen noted there were only nine controlled trials which lasted a mere 6-12 months, involving a total of 10,000 subjects. Eight of those nine trials were not designed to measure clinically meaningful results, and the one trial which evaluated adverse cardiovascular outcomes concluded a higher risk of those outcomes for patient taking Invokana as compared to older diabetic drugs such as metformin.

Many believe this is simply not sufficient data to determine whether Invokana’s benefits outweigh the potential safety concerns. Invokana was approved by an FDA panel vote of 10 to 5, despite the fact that several members of the panel raised concerns regarding impaired kidney function and cardiovascular risks. Those taking Invokana should be aware of the potentially serious risks associated with the drug and should consult an experienced attorney if they have suffered injury from the drug.