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FDA strengthens Invokana warning


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As lawsuits continue to be filed alleging that the use of the diabetes drug Invokana (canagliflozin) produced the unreasonable risk of diabetic ketoacidosis and its complications, the U.S. Food and Drug Administration has ramped up its warnings about Invokana and about similar drugs.

The FDA issued a warning in May about the risk of ketoacidosis in patients using Invokana or another SGLT-2 inhibitor – going no further than stating that the matter would be further investigated. But the FDA’s latest warning, which was issued Friday, involved labeling changes for these drugs. That’s how serious the risk is.

Ketoacidosis is serious, too.

“As fat is broken down,” the U.S. National Library of Medicine wrote, “acids called ketones build up in the blood and urine. In high levels, ketones are poisonous. This condition is known as ketoacidosis.” The library, which belongs to the National Institutes of Health, reported the following possible complications of ketoacidosis:

· Fluid buildup in the brain (cerebral edema)

· Heart attack and death of bowel tissue due to low blood pressure

· Kidney failure

Many Invokana patients who filed suit may feel vindicated by the federal agency’s most recent intervention.

“SGLT2 inhibitors,” according to the FDA, “are a class of prescription medicines that are FDA-approved for use with diet and exercise to lower blood sugar in adults with type 2 diabetes.”

FDA officials examined adverse event reports that they received from March 2013 through October 2014. They found 73 cases of ketoacidosis among patients using Invokana or a drug in its class.

“All patients required hospitalization or treatment in an emergency department,” the FDA reported Friday. “In many cases, ketoacidosis was not immediately recognized because the blood glucose levels were below those typically expected for diabetic ketoacidosis. As a result, treatment of the ketoacidosis was delayed in some cases. We also identified 19 cases of life-threatening blood infections (urosepsis) and kidney infections (pyelonephritis) that started as urinary tract infections with the SGLT2 inhibitors … All 19 patients were hospitalized, and a few required admission to an intensive care unit or dialysis in order to treat kidney failure.”

Medical science, of course, has been examining the risk that plaintiffs in Invokana lawsuits assert. For instance, the August 2015 edition of the Journal of Clinical Endocrinology and Metabolism published a literature review that researchers with NIH and with the University of Maryland School of Medicine wrote.

They concluded, “Based on the physiology of SGLT2 and the pharmacology of SGLT2 inhibitors, there are several biologically plausible mechanisms whereby this class of drugs has the potential to increase the risk of developing diabetic ketoacidosis.”

The FDA examined the totality of the ketoacidosis risk, on the one hand, and the risks of serious blood and kidney infections, on the other hand.

“As a result, we have added new Warnings and Precautions to the labels of all SGLT2 inhibitors to describe these two safety issues, and to provide prescribing and monitoring recommendations,” the FDA wrote Friday. “We are also requiring manufacturers of SGLT2 inhibitors to conduct a required post-marketing study. This required enhanced pharmacovigilance study requests that manufacturers perform analyses of spontaneous post-marketing reports of ketoacidosis in patients treated with SGLT2 inhibitors, including specialized follow-up to collect additional information, for a period of 5 years.”

This class of drugs, in addition to Invokana, includes Farxiga (dapagliflozin) and Jardiance (empagliflozin).

Someone who has used Invokana or another SGLT2 drug and who has since suffered from diabetic ketoacidosis or a blood or kidney infection may be entitled to receive compensation for medical expenses and for other losses. One way to find out whether you have a case is to contact an attorney at Reich & Binstock.

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