New Drug Safety Announcement By European Medicines Agency (EMA) Intended To Help Minimize Risk Of DKA Side Effect With This Class Of New Diabetes Drugs
The Sodium-Glucose Cotransporter-2 (SGLT2) Inhibitors diabetes drugs currently available in the US are:
Invokana — FDA Approval: 2013
Invokamet — FDA Approval: 2014
Farxiga — FDA Approval: 2014
Xigduo XR — FDA Approval: 2014
Jardiance — FDA Approval: 2014
Glyxambi — FDA Approval: 2015
Synjardy — FDA Approval: 2015
These new SGLT-2 inhibitors diabetes medications are distinctive from other diabetes drugs insofar that they make the kidneys extract a significant amount of sugar from the blood to be excreted in urine.
On February 12, 2016 the European Medicines Agency (EMA) issued a drug safety alert about the possibility of atypical cases of diabetic ketoacidosis (DKA) associated with this relatively new class of medications used to treat type 2 diabetes.
This EMA announcement, "SGLT2 inhibitors: PRAC makes recommendations to minimise risk of diabetic ketoacidosis", followed a review conducted by the agency's Pharmacovigilance Risk Assessment Committee (PRAC).
From this February 2015 EMA drug safety alert concerning Invokana, Farxiga, Jardiance, and similar diabetes drugs we get these facts about this DKA side effect:
Diabetic ketoacidosis is a serious complication of diabetes caused by low insulin levels. Rare cases of this condition, including life-threatening ones, have occurred in patients taking SGLT2 inhibitors for type 2 diabetes and a number of these cases have been atypical, with patients not having blood sugar levels as high as expected.
An atypical presentation of diabetic ketoacidosis can delay diagnosis and treatment. Healthcare professionals should therefore consider the possibility of ketoacidosis in patients taking SGLT2 inhibitors who have symptoms consistent with the condition even if blood sugar levels are not high.
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We get some context for this latest development as regards the drug safety of Invokana, Farxiga, and Jardiance from this February 12, 2016 Medscape Medical News article, "EMA on Lowering Risk of Diabetic Ketoacidosis With SGLT2 Inhibitors":
The issue initially came to light in May 2015, when the US Food and Drug Administration issued a notice on the basis of 20 cases of DKA associated with SGLT2 inhibitors reported to the agency's adverse-event reporting system. A month later, the EMA initiated its review and identified 101 cases worldwide associated with type 2 diabetes.
Diabetic ketoacidosis is a serious complication of diabetes caused by low insulin levels. The issue is of considerable concern because ketoacidosis is not typically observed in patients with type 2 diabetes....
Despite the concerns, US organizations such as the American Association of Clinical Endocrinologists (AACE) and the American College of Endocrinology (ACE) have advised that use of SGLT2 inhibitor drugs should continue in patients with type 2 diabetes, in line with current recommendations.
Cases of DKA associated with off-label use of SGLT2 inhibitors in type 1 diabetes have also been reported; the AACE also said that the investigational use of this drug class in type 1 should continue, since initial results have shown a promising impact on glycemic control.
We will watch for additional drug safety warnings for Invokana, Farxiga, Jardiance, and similar diabetes drugs about incidents of atypical diabetic ketoacidosis (DKA) as well as other serious side effects.