Invokana Label Warning Updated to Include Risk of Ketoacidosis: Better Late Than Never | Levin Papantonio - Personal Injury Lawyers

Invokana Label Warning Updated to Include Risk of Ketoacidosis: Better Late Than Never

It took far too long, but as of this past August, the warning label for the diabetic drug Invokana (canagliflozin) was finally updated to include the risk of ketoacidosis. It was also updated for a rival drug, Farxiga (dapaglifozin), as well as Jardiance (empagliflozin). All three of these medications are part of the gliflozin class, which are designed to prevent the kidneys from reabsorbing blood sugar, allowing it to be passed in the urine. Ironically, these drugs have caused the same kind of kidney damage they were intended to prevent.

The new label warning acknowledges that “reports of ketoacidosis...have been identified in postmarketing surveillance in patients with Type 1 and Type 2 diabetes mellitus receiving sodium glucose co-transporter-2 (SGLT2) inhibitors...fatal cases of ketoacidosis have been reported in patients taking INVOKANA.” The new warning further adds that “INVOKANA is not indicated for the treatment of patients with Type 1 diabetes.” Patients and doctors are advised that “ketoacidosis associated with INVOKANA may be present even if blood glucose levels are less than 250 mg/dL.”

The FDA document points out that “in many of the postmarketing reports, and particularly in patients with Type 1 diabetes, ketoacidosis was not immediately recognized and institution of treatment was delayed because presenting blood glucose levels were below those typically expected for diabetic ketoacidosis”

It is curious as to why this type of warning had not been issued before. One patient, posting on an online forum for Type 1 diabetics, reported over two years ago that she had had her first bout with ketoacidosis after having taken Invokana for only two weeks. Keep in mind that Type 1 diabetes is a completely different disorder from Type 2, and is a genetic condition that runs in families. Between the time she started on Invokana and the time she was taken off it, she was hospitalized four times for ketoacidosis – despite having normal blood sugar levels. Yet, her doctors were mystified, unable to determine what the connection was. Another patient reported that she had never been hospitalized for ketoacidosis in her entire life – and again, physicians had no idea why she would have had the condition with such low blood sugar levels.

Diabetic ketoacidosis is a condition that results when glucose builds up in the bloodstream and levels become so high that the cells become overloaded. When this happens, the body starts breaking down fat cells to fuel metabolism. When this happens, the blood becomes dangerously acidic. Invokana and other SGLT2 inhibitors are supposed to eliminate that excess glucose through the urine. This is why doctors have been unable to figure out the connection.

It's possible – and even likely – that Johnson & Johnson was aware of the problem, however.