There are reported cases of serious, sometimes life-threatening cases of diabetic ketoacidosis in patients with type 2 diabetes treated with SGLT2-inhibitors. This is reported by the manufacturers after consultation with the European Medicines Agency (EMA) and the Bulgarian Drug Agency (BDA).
In a number of these reports the clinical presentation of the condition is atypical, as only moderately elevated blood glucose levels are observed. The statement says that such atypical clinical presentation of diabetic ketoacidosis in patients with diabetes could delay diagnosis and treatment.
The patients treated with inhibitors of SGLT2, with symptoms of acidosis should be tested for ketones to prevent the delay in diagnosis and treatment.
Cases of diabetic ketoacidosis have also been reported in patients with type 1 diabetes mellitus, who were given inhibitors of SGLT2. The pharmaceutical companies remind the prescribing physicians that type 1 diabetes is not permitted therapeutic indication for this class of drugs.
In Bulgaria dapagliflozin is registered from this class of inhibitors under the trade name Forxiga 100 mg x 30.