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SGLT2 inhibitors and diabetic ketoacidosis: PRAC makes recommendations to minimise risk to patients

February 14, 2016 – 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,

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SGLT2 Inhibitors and ketoacidosis: Warnings about too much acid in the blood and serious urinary tract infections included in new drug labels

December 5, 2015 – A safety review by the American Food and Drug Administration (FDA) has resulted in the addition of specific warnings to the drug labels of a specific class of type 2 diabetes medicines called sodium-glucose cotransporter-2 (SGLT2) inhibitors about the risks of too much acid in the blood and of serious urinary tract infections.

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Type 2 Diabetes: Risk for bone fracture and decreased bone mineral density under canagliflozin therapy

 September 12, 2015 – Drug Safety Information: The American Food and Drug Administration (FDA)  has just strengthened the warning for the type 2 diabetes medicines containing  canagliflozin as active ingredient, i.e. Invokana and Invokamet, related to the increased risk of bone fractures, and added new information about decreased bone mineral density in afflicted patients.

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Medicines based on SGLT2 inhibiton may result in ketoacidosis, a serious condition of too much acid in the blood

May 15, 2015 – The American Food and Drug Administration (FDA) is warning that the type 2 diabetes medicines Canagliflozin (Invokana), Dapagliflozin (Farxiga), and Empagliflozin (Jardiance) may lead to ketoacidosis,

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FDA approves Empagliflozin [Jardiance], a SGLT2 inhibitor, to treat type 2 diabetes

August 1, 2014 – The U.S. Food and Drug Administration today approved Jardiance (empagliflozin) tablets as an addition to diet and exercise to improve glycemic control in adults with type 2 diabetes. Type 2 diabetes affects approximately 26 million people and accounts for more than 90 percent of diabetes cases diagnosed in the United States.

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