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 Invokana, Farxiga, Jardiance, and similar new diabetes drugs in the Sodium-Glucose Cotransporter-2 (SGLT2) Inhibitors class of drugs. These still relatively new medicines 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.
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 other SGLT2 inhibitors 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.
The SGLT-2 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
We will watch for additional drug safety warnings for these new diabetes drugs about incidents of atypical diabetic ketoacidosis (DKA) as well as other serious side effects.[Read this article in full at original source]
Invokana / Farxiga / Jardiance
Free Case Evaluation
Strictly Confidential, No Obligation.