In May 2015, the Food and Drug Administration (FDA) warned doctors and patients that certain types of type 2 diabetes drugs, including Invokana (canagliflozin), could cause diabetic ketoacidosis (DKA) in some patients. This is a serious condition in which the blood becomes too acidic, and without treatment it can result in hospitalization, coma, and sometimes death.
Considering the concerns, researchers in a recent published article suggested that doctors learn more about the symptoms and risk factors for DKA, so they can help detect potentially vulnerable patients at an earlier time.
Researchers Note that Over 100 Patients Affected by DKA
The article was published in the journal Diabetes Care, and is written by researchers Julio Rosenstock of the Dallas Diabetes and Endocrine Center, and Ele Ferrannini, of Italy’s Institute of Clinical Physiology. They note that in addition to the 20 cases of DKA in patients taking SGLT2 inhibitors (like Invokana), the European Medicines Agency (EMA) announced a total of 101 cases of DKA reported worldwide as of May 2015. All were serious and required hospitalization.
“It is not unusual that serious safety issues related to a new drug go undetected during the relatively short clinical development programs for regulatory drug approval,” the researchers wrote. As new information about potential safety issues becomes available after the drug reaches the market, however, the authors explained that a labeling update may be required. Indeed, they commented that “[i] f serious enough, the issue may require a label warning and a mitigation plan or even consideration of drug withdrawal.”
While there has been no talk of an Invokana recall yet, patients who have been affected by DKA may be eligible to file a personal injury lawsuit to recover damages.
DKA May Be Missed in Type 2 Diabetes Patients
DKA is a condition that frequently occurs in patients with type 1 diabetes, but so far has been more rare in those with type 2 diabetes. This is one of the reasons that the FDA appeared surprised to find cases of type 2 diabetes patients who were taking drugs like Invokana and were diagnosed with DKA.
The researchers note that DKA can be very serious, and that diagnosis can be missed if patients have only mildly elevated blood sugar levels. Type 1 diabetes patients who develop DKA typically have high blood sugar levels, but the FDA found that the type 2 diabetes patients who were diagnosed with it had only mildly elevated blood glucose levels—which was surprising.
“DKA most commonly occurs in patients with type 1 diabetes and is usually accompanied by high blood sugar levels,” the FDA stated. They added that the cases they reviewed were not typical because most of the patients “had type 2 diabetes and their blood sugar levels, when reported, were only slightly increased compared to typical cases of DKA.”
The researchers on this latest study note that this one unusual characteristic could delay diagnosis and treatment, which could be dangerous for patients.
Researchers Advise Doctors to Watch Patients on Invokana for Signs of DKA
The researchers advise doctors to be on the lookout for patients with autoimmune diseases, as they may be more vulnerable to DKA when taking SGLT2 inhibitors. Patients who have intercurrent illnesses, or who are coming out of surgery, may also be at a greater risk for the condition. Those who have reduced food and fluid intake, or who have a history of alcohol use, should also be watched carefully.
The researchers also suggested that doctors advise patients taking drugs like Invokana to report any symptoms of unexplained nausea, or even just symptoms of not feeling well. Discovering DKA early is the best way to treat it before it can cause more serious damage.
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